Regulatory Consultants

Medsafe has been informed that the following people provide independent regulatory, clinical and other consultancy services to the pharmaceutical sector in New Zealand (as of July 2007). These people work independently from Medsafe. Medsafe accepts no liability for the qualifications, accuracy or reliability of these consultants. No warranty or recommendation is to be assumed from the provision of this information or the omission of contact details for any other consultant.

Consultant	Service(s)
Ranjan Acharya HLS Innovations Limited PO Box 12-1365 Henderson, Auckland Mobile: +64-27-356-1732 USA: +1-206-801-1966 E-mail: enquiries@hlsinnovations.com Web: http://www.hlsinnovations.com/	Control system engineering support (GAMP Lifecycle, cGMP, ERES, 21 CFR Part 11, PIC/S Annex, ISA S95, ISA S88); Technical documentation for manufacturing systems; Control system obsolescence; MES and OEE; Control system security.
ADVANTAGE Medical Products Consulting Pty Ltd Bren Milsom and Associates 5 Yatama Place (PO Box 339) Currumbin Waters QLD 4223 AUSTRALIA Branch Offices in Adelaide and Brisbane Phone: +61 7 5522 4880 Fax: +61 7 5522 4128 Mobile: +61 (0) 407 533 048 Email: bmilsom@advantagempc.com.au Website: www.advantagempc.com.au	We provide guidance and advice on: TGA and MEDSAFE liaison Classification, ARTG registration and listing, device inclusion, All TGA & Medsafe, on line systems ELF, DEAL, COMET, WAND, GMDN coding etc Advertising Formulation, Packaging and Labelling Manufacturing, GMP compliance, site master files Importing and Exporting Trade Practices Appeals Problem Reports and Recalls Poisons scheduling Complementary Medicines and Sports Supplements NICNAS/ERMA: Cosmetics and Toiletries Other government requirements
Gillian Alexander Saltarelo Holdings Ltd PO Box 51 598 AUCKLAND Phone/fax: (09) 533 7171 Mobile: 021 868 200 E-mail: Saltarelo@xtra.co.nz	Regulatory Affairs - high, medium and low risk products Medical devices and WAND notifications Dietary supplement advice and COMET notifications Rescheduling applications PHARMAC submissions and issues Strategic planning Advertising writing and review
Rob Allman Consulting 14 Spencer Street Crofton Downs Wellington New Zealand Phone 04 4791029 Mobile 021 1024268 E mail: rl.allman@xtra.co.nz	Specialist advice on regulatory affairs issues and the administration of legislation and regulations Strategic planning and advice Development, implementation and monitoring of quality assurance systems Project management Advice on products at the medicine/food interface
Nikki Anderson Anderson Consulting & Contracting Ltd 66 Waiora Rd Stanmore Bay Whangaparaoa Auckland 0932 Mobile: (0276) 300297 Ph/Fax: (09) 4240457 Email: warren_nikki@xtra.co.nz	20+ years auditing and regulatory experience Quality management audits & consultancy GMP advice & assistance Regulatory advice SOP preparation Pharmacy Pre-purchase Inspection Pre-Audit preparation Post-Audit compliance
API-Tek Pty Ltd Evelyn Yeoh PO Box 190 Gordon NSW 2072 Australia Phone/Fax (612) 9498 4409 Mobile: (61) 0402 338185 Email: yeoh@ozemail.com.au	Medical Device Applications Regulatory Advice & Support for Complementary, Non-Prescription & Precription Medicines
Archer Emery & Associates Paul Archer Julie Emery Alan Duff Ruby Campbell Phone: +61 1300 786 477 Fax +61 2 6281 3872 Email: info@archeremery.com.au Website: www.archeremery.com.au	50 years TGA experience at your service Archer Emery and Associates provides advice and assistance to companies that import, manufacture or sell medicines in Australia and New Zealand. Consultants Paul Archer, Julie Emery, Alan Duff and Ruby Campbell have a wealth of experience in the pharmaceutical industry including a combined 50 years with the TGA. We know and understand TGA and Medsafe legislation, procedures and systems and the industry they serve. Our experience will help you achieve your goals quickly and cost-effectively. Our services include advice on: New product concepts Relationships with the TGA and Medsafe Applications to the TGA and Medsafe Manufacturing and GMP of medicines and medical devices Medicines scheduling and ‘switch’ applications to NDPSC Sunscreen and cosmetic regulation Preparation for the ANZTPA In addition we provide: On-the job staff training and mentoring Review and update of product labels and technical specifications
Leo Barnes CELEO P O Box 294 Lindfield NSW 2070 AUSTRALIA Phone/Fax/Ans: +61 (0)2 8904 0092 Mobile: + 61 (0)4 1234 8085 Email: leo.barnes@ihug.com.au	International Medical Regulatory Accreditations include: European Notified Body (TUV SUD) – Lead Auditor for Medical Devices Directive (MDD) and Active Implantable Medical Devices Directive (AIMDD). Technical Certifier for IECEE CB Scheme FDA third party reviewer of 510(k) submissions Canada Medical Devices Regulations – ISO 13485: 2003 auditor. Japan PAL auditor (new).
BELTAS Ltd Clinical Research Organisation PO Box 99 728, Newmarket Auckland, NEW ZEALAND Phone: +64 9 520 2410 Fax: + 64 9 520 2442 E-mail: contact.health@beltas.com Website: www.beltas.com North America BELTAS Phone: (650) 276 0422 Europe BELTAS BV Phone: +31 (63) 862 0467	BELTAS CRO provides clinical research services in New Zealand, Australia and Europe on behalf of local and international clients. BELTAS manages Phase I - IV clinical trials for pharmaceutical, biotechnology and medical device companies, and conducts clinical studies on behalf of international CRO’s. Services Trial Feasibility & Site Selection Study Design & Data Management Project Management & Planning Regulatory & Ethics (IRB) Approval Quality Assurance & Auditing Study Start-up Study Monitoring Medical & Report Writing Regulatory Affairs Training Resources Authorities & FAQs
Biotech Regulatory Solutions Katy King Principal Consultant PO Box 135 Church Point NSW Australia 2105 Phone: +61 2 9979 2180 Fax: + 61 2 9979 2170 Mobile: +61 (0)409 747 074 Email: katy@biotechregulatory.com.au Website: www.biotechregulatory.com.au	Regulatory strategic consultancy (Rx, biotech, OTC, medical devices and food) Regulatory dossier review, gap analysis, submission and project management (prescription, biotech, generic, OTC) Drug development planning and project management Clinical Research Services - regulatory applications & assistance with clinical trial set-up Literature Based Submissions Orphan Drug applications Import Permits
BRANDWOOD : BIOMEDICAL Pty Ltd ACN 128 762 505 Suite 4.08, 460 Pacific Highway St Leonards NSW 2065 Australia Web: www.brandwoodbiomedical.com.au Email: clientenquiry@brandwoodbiomedical.com.au Phone: +61 (0)2 9906 2984	Brandwood Biomedical provides technical and regulatory consulting and training services, particularly suited to the needs of smaller medical device developers. The Principal, Dr Arthur Brandwood has over 20 years experience in the medical technology field in commercial product development, academia and government including as Director of Devices Registration and Assessment, and of the Biomaterials and Engineering Laboratories at the TGA. We can help you to: develop the right technical and regulatory strategy for your business; achieve appropriate solutions for preclinical and clinical product testing including compliance to ISO 10993, conduct ISO 14971 risk assessment develop and implement ISO 13485 quality systems prepare regulatory submissions for Australia, US FDA, Europe and other jurisdictions develop your skills through training and short courses in regulatory affairs and medical device development.
Michelle Carbines PO Box 224 Matakana 0948 Rodney District Phone (09) 423 8855 Mobile (027) 292 2172 Email: mcarbines@slingshot.co.nz	Regulatory Affairs Dossier review and preparation Ethical and generic applications Rescheduling applications Medical Devices and Wand notifications Ethics Committee and Scott applications ANZTPA preparation Medical Affairs Advertising Compliance Assessment Pharmacovigilance Quality Medicine Recalls Quality Management including SOPs Quality Assurance including compliance
Mr Vinil Chandrashekar Regulatory Concepts Pty Ltd Unit 9, 7 Anella Ave Castle Hill NSW 2154 Australia Ph: +61 2 9846 1902 Fax: +61 2 9846 1930 Web: www.regcon.com.au	Prescription medicine registrations in Australia and NZ
Clinical and Regulatory Services Limited (CARSL Consulting) PO Box 480 PUKEKOHE Brian Day Phone: (09) 238 3447 Fax: (09) 238 9239 Mobile: (0274) 884 411 E-mail: carsl@xtra.co.nz Brigitta Vasista Phone/Fax: (09) 630 1003 Mobile: (021) 827478 E-mail: brigitta.vasista@ihug.co.nz Website: www.carsl.co.nz	Regulatory: ethical, generic, OTC and complementary medicines Clinical research Project management including product development or sourcing Dossier review and preparation Product sponsorship and strategic advice Quality management including audits and SOP preparation. Quality Assurance GMP Training Medicine recalls Advertising compliance assessment Product labelling, datasheets, CMI Medical device (DEAL) notifications Complementary medicine COMET notifications
David Daley PharmEquip Ltd 3/1 Old Wairoa Rd PO Box 72 725 PAPAKURA 1730 AUCKLAND NEW ZEALAND Phone: (09) 298 8196 Fax : (09) 298 4027 Mobile: (025) 975 488 E-mail: dave@pharmequip.com Website: www.pharmequip.com	GMP Quality Systems Facility Design and Construction Equipment Design, Build, Installation and Commissioning Process & Equipment Integration Qualification & Validation Product Development, Product Formulation and Trials Development Pharmaceutics SOP, IQOQ, Labelling and Support Documentation Technical Services for the Pharmaceutical, Biotechnology. Animal Health & Complimentary Medicine Industries Regulatory Compliance Project Management
Dr Helena Dickenson (PhD Pharmacology) Director & Principal Consultant Regulatory Concepts Pty Ltd Unit 9, 7 Anella Ave Castle Hill NSW 2154 Australia Ph: +61 2 9846 1900 Fax: +61 2 9846 1930 E-Mail: helenad@regcon.com.au Web: www.regcon.com.au	Business services Industry representation Training services Alliances services Overseas regulatory services.
Engel Hellyer & Partners Pty Ltd PO Box 5462, West Chatswood, NSW 1515 Australia Level 4, 815 Pacific Highway CHATSWOOD, NSW 2067 AUSTRALIA Phone: + 61 2 9413 9799 Fax: + 61 2 9413 9899 Email: enquiries@engelhellyer.com Website: www.engelhellyer.com	GMP advice and assistance. Advertising compliance assessment Formulation advice Technical writing Medical Devices WAND/ DEAL applications TGA Australia Listings and Registrations NICNAS Australia notifications
ESR Pharmaceuticals Group Kenepuru Science Centre 34 Kenepuru Drive PO Box 50-348 PORIRUA Phone: +64 4 914 0700 Mobile: 021 890 588 Fax: +64 4 914 0649 E-mail: ralph.richardson@esr.cri.nz Web site: www.esr.cri.nz	Regulatory Bioequivalence studies Product assessment & comparison
Phillipa Evans Clinical Monitoring Concepts Limited 2/171 Coronation Road Hillcrest North Shore Auckland New Zealand Phone: (09) 441 6516 Mobile: 021 7262 57 Email: cmc_clinicalresearch@xtra.co.nz	Clinical Research Services Site Management and Monitoring (Onsite Monitoring; Phase I - IV; Project Management) Close-out Visits Ethics and Regulatory Applications
Gavin Frost MBChB, DPH Strategic consultancy and support to take new and existing pharmaceutical and healthcare products to the next level of development and market success P.O. Box 37-313 Parnell Auckland Phone: 64 9 3099090 Mobile: 021 1597819 email: GavinFrost@slingshot.co.nz	Specialist advice and support on strategic and pharmaceutical policy issues, market development, planning, sponsorship, marketing, pricing applications and distribution in New Zealand Promotional and educational material development, advertising advice and compliance assessment, product comparison, clinical evidence review and gap analysis Clinical research support, medical and technical writing for all audiences, technical support of product information, data sheets, CMI etc.
A/Prof. Sanjay Garg School of Pharmacy Faculty of Medical and Health Sciences University of Auckland Building 504, LGF, 85 Park Road Grafton Auckland New Zealand Phone: 64 9 373-7599 ext 82836 Mobile: 021 297 8590 Fax: 64 9 367 7192	Regulatory: Analytical GLP training and services Preformulation studies Stability assessment and improvement Preclinical and clinical formulation development Quality Assurance, audits, documentation Dossier review and preparation Herbal drug formulation and standardization In-vitro release or dissolution studies
Green Lane Coordinating Centre Research Organisation Ltd PO Box 19143 Avondale Auckland 1746 New Zealand Phone: + 64 9 820 2050 Fax: + 64 9 820 2059 Email: contact@glcc.org.nz Website: www.glcc.org.nz	Project Management Data Management Site Management Regulatory Submissions Monitoring Services Training and Education Event Management
Roy Hardman Resultist Right Time Business Pty Ltd PO Box 55 Glen Iris Victoria 3146 AUSTRALIA Phone: 00 61 (3) 9885 5388 Fax: 00 61 (3) 9885 7488 Mobile 0061 0419 100 978 E-mail: roy@righttimebusiness.com.au Web: www.righttimebusiness.com.au	Specialist in Medical Devices Applications Medial/Dental for WAND and TGA. Complete understanding of Dental Industry requirements. Clinical Advisor for Dental Materials. Complete Audit for product listings with WAND and TGA. Advisor on product strategy and market development. Product development assistance. Marketing and distribution in Australia and New Zealand. Work Place Training and Development. Qualified Business and Marketing trainer. Alliances with extensive network of providers to comply with government requirements for regulations and tenders.
Pauline Harris PharmAffairs Regulatory Services Ltd 29 James Evans Drive Northcote Auckland 0627 Phone: +64 (9) 419 9451 Mobile: 021 185 0566	Regulatory services: generic, ethical and OTC submissions strategic planning and advice core dossier preparation / development advice core file review / compliance assessment Labelling / Data sheet / CMI EU regulatory authority experience
In Vivo Communications 27-29 William Pickering Drive PO Box 300667 Albany North Shore City New Zealand Phone: 09 4485408 Fax: 09 4485409 e.mail: s.mcwilliams@invivocom.com	Strategic education and communication programmes Medical writing Continuing Medical Education Promotional and educational materials In New Zealand and Australia
International Certifications Ltd David Evans 30 Bishopsgate Business Centre Bishop Dunn Place, Botany South, Auckland, NZ P.O.Box 259-324, Greenmount, Manukau, 2141, NZ Phone: +64 9 273 4099 Freephone: 0800 ISO 9001 Fax: +64 9 273 6099 Web: www.intlcert.com E-mail: admin@intlcert.com	Certification and training for: Healthcare standards (HDSS, Community, Ambulance, etc..) Quality management (ISO 9001, Quality Warranty, etc..) Medical device manufacture (ISO 13485) Environmental management (ISO 14001, Eco Warranty, etc..) Health and safety management (AS/NZS 4801, OHSAS 18001, etc..) Food safety management (ISO 22000, HACCP Warranty, BRC, NZFSA, etc..) Risk management (AS/NZS 4360, Risk Warranty, etc..)
Richard Keene Keene Manufacturing Solutions 59 John Gill Rd, Howick Auckland, New Zealand Phone: 021 278 1845 Fax: (09) 534 5348 A/hrs: (09) 534 5347 Email: keeneman@xtra.co.nz	22 years experience in the pharmaceutical, dietary supplements, and animal health industries, in : manufacturing, product development, quality assurance, quality control, logistics (including ERP systems), validation, GMP quality systems. Have experience in the implementation and application of : NZ pharmaceutical and animal, TGA, European, and FDA; codes of GMP; as well as ISO 9000, NZFSA HACCP, Dairy, and MAF Meat and Fish regulations Services include : Development, implementation and improvement of quality and manufacturing systems (GMP and non-GMP) GMP Training Auditing : GMP compliance; quality and manufacturing systems; supplier Validation : equipment, process, product, analytical, cleaning People management and leadership Project management and change management Problem solving and process improvement Product development (liquids, powders, solid dose)
Kendle Pty Limited 156-158 Drummond Street Oakleigh Victoria 3166 Australia Phone: +61 3 9567 7600 Fax: +61 3 9567 7699 Level 2 454-456 Pacific Highway St Leonards NSW 2065 Australia Phone: +61 2 8437 9200 Fax: +61 2 8437 9299 Email: bingham.judy@kendle.com	Strategic consultancy Dossier review and gap analysis Clinical trial and marketing submissions Medical writing Development & Commercialisation (Pharmaceuticals, Devices, and Diagnostics) Technical due diligence Quality systems Medical devices WAND/DEAL applications Clinical Research, Phase I - IV Health Economics and Health Outcomes research Data Management and Statistics Pharmacovigilance
Donna Le Quesne PO Box 22-165 Khandallah WELLINGTON Phone: (04) 479 8315 Fax: (04) 479 8315	Regulatory Clinical research Sales and marketing
Graham Leslie Medra Services Ltd Wellington New Zealand Phone/fax: +64 6 323 8573 Mobile: +64 274 537543 E-mail: medra@xtra.co.nz Mail: PO Box 115, Feilding	Regulatory strategy and product development Core Regulatory Affairs Reimbursement strategy and applications GMP and QA management Pharmacovigilance Advertising compliance
Dr Carole Malcolmson Carole Malcolmson Consulting 19 Maungakiekie Avenue Greenlane Auckland Phone: (09) 524 0595 Mobile: 021 524 059 E-mail: carole_malcolmson@hotmail.com	Quality Systems GMP Validation Auditing Product Development Technical Writing Regulatory and Expert Reports Workplace Training
Tony Mann Research Associates Ltd P.O.Box 17-539 Christchurch New Zealand Phone: 64 (21) 71 36 71 Fax: (03) 326-4807 E-mail: mannt@xtra.co.nz Web site: www.ral-nz.com	Clinical Research Feasibility studies Regulatory Monitoring SOP preparation
Mi Services Group P O Box 8258, Symonds Street 6th Floor 110 Symonds Street AUCKLAND Phone: + 64 9 358 4114 Fax: + 64 9 358 4141 E-mail: nzinfo@mi-services.com Web site: http://www.mi-services.com	IT Systems Consultants specialising in 21CFR11 Compliance, GAMP4 Methadology, GMP Consulting & Risk Assessments and General Systems Related Compliance & Validation Services
Maurice Parlane John Kennerley Louise Dibley New Wayz Consulting Limited PO Box 36496 Northcote 1309 AUCKLAND Phone: +64 9 419 8029 Fax: +64 9 419 5029 Mobile: +64 21 650 692 E-mail: newwayz@newwayz.co.nz Web site: http://www.newwayz.co.nz	New Wayz Consulting Ltd delivers consulting services based on a risk-based approach for businesses entering or established in the Good Manufacturing Practice (GMP) regulated environment. We have the expertise and commitment to provide best practice solutions to meet all operational and project related quality, technical, engineering, and compliance demands. We offer a comprehensive range of consulting services in the following areas: GMP / GLP and Regulatory Compliance Qualification & Validation Manufacturing Best Practice and Technical Support Good Engineering Practice (GEP) Critical Process & Equipment Engineering Contract & Business Services
MONDOPHARM CONSULTING Emma Post MPS, RegPharmNZ, B.Pharm, PG Dip Sci P.O Box 56 187 Dominion Rd Mt Eden Auckland New Zealand Ph: +64 9 6388 277 Fax: +64 9 6388 276 Mob: 021 668 369 Email: emma@mondopharm.co.nz	Help new companies to set up a wholesale business, GMP training, SOP preparation Advice on regulatory & GMP issues regarding medicines and controlled drugs Preparation of documentation and best practice procedures for Pharmacy Quality Audits Site inspection and guidance for new pharmacies COMET registrations Pre marketing queries- importing products into the NZ market Advice on ingredients in medicines, complimentary medicines ,toiletries Advice on labelling, advertising of new medicines, cosmetics, toiletries
Janet Patterson Research Audit International Ltd PO Box 56 570 Dominion Rd AUCKLAND Phone: (09) 849 3885 Fax: (09) 849 3886 Mobile: (021) 724 521 E-mail: ResearchAudit@xtra.co.nz	Regulatory Clinical research GCRP and research auditing Training in clinical trials, GCRP and audit preparation for auditees Clinical trial report writing Review of protocols and documentation for compliance with GCRP
Pharmaceutical Marketing NZ Ltd PO Box 105 535 Auckland PH 64 9 377 0660 Fax: 64 9 377 0650 Mobile: 64 21 1173 473 Email: john@pharmamark.co.nz	Our consultants have more than 5 decades of experience in the NZ pharmaceutical industry, we provide all of the following services. Product sponsorship, regulatory and strategic advice for ethical, generic, OTC, complementary medicines and medical devices. Development & Commercialisation. Sales and Marketing Management. Advertising compliance assessment and medical writing. Health Economics and Health Outcomes research. Quality management including audits and SOP preparation.
Pharmaceutical Solutions Ltd Linda Hill Level 2, 109-111 Quay Street Pier 1 Queens Wharf Auckland 1010 P O Box 105070 Auckland 1143 New Zealand Phone: +649 3798205 Fax: +649 3798244 Mobile: +6427 4751270 Email: lindahill@pharma-solutions.co.nz Website: www.pharma-solutions.co.nz	Clinical Research and Regulatory Specialists Clinical Research Services: Study feasibility and site identification, Investigator selection and site validations, Ethics Committee and Medsafe (SCOTT) applications, Investigator site initiations, Site management including monitoring throughout New Zealand and Australia, CRA’s with broad therapeutic experience, Expertise in monitoring Phase I to Phase IV clinical trials Regulatory Affairs Services – CMNs, NMA’s etc, general advice regarding NZ requirements, services customised to client needs
Mr James Prasad Regulatory Concepts Pty Ltd Unit 9, 7 Anella Ave Castle Hill NSW 2154 Australia Ph: +61 2 9846 1908 Fax: +61 2 9846 1930 Web: www.regcon.com.au	Prescription and OTC registrations in Australia and NZ, specialist advice with New Zealand applications
Bob Tribe Trevor Schoerie Andrew Edmeades PharmOut Limited / PharmOut Pty Ltd New Zealand Australia Auckland Melbourne Level 3 Level 9 60 Cook Street 440 Collins Street Auckland Melbourne New Zealand Victoria 1141 3000 Tel. +64 9 355 1773 Tel. +61 3 8640 0933 Fax +64 9 909 6012 Fax +61 3 8610 0169 E-mail: trevor.schoerie@pharmout.co.nz bob.tribe@pharmout.com.au Web site: http://www.pharmout.co.nz http://www.pharmout.com.au	PharmOut is an international consulting company with over 30 staff in offices in Australia and New Zealand. We offer – Consulting Services in Good Manufacturing Practice (GMP), Validation, Continuous Improvement, Conformity Assessments and Regulatory Affairs. Products such as Device and Pharmaceutical Quality Systems, EDMS, CAPA systems, Master Control. Training in GMP, GLP, Validation and Risk Assessments
Harry Pose Consultant Spectrum Technology Pty Ltd 24 A Macgowan Avenue Glenhuntly Victoria 3163 Australia Postal Address PO Box 422 Glenhuntly Victoria 3163 Australia Telephone +613 9578 1420 Fax +613 9578 1415 Mobile +614 1171 3444 Email h.pose@bigpond.com Web www.harrrypose.com	Preparation of Therapeutic Goods Administration (TGA) submissions for registrations and listings. TGA Advice TGA representation Clinical trials Quality systems and compliance IPU's etc WAND Recalls Field corrections TGA representation Device tracking Quality Assurance auditing
Robert Forbes & Associates Pty Ltd PO Box 123, Annandale NSW 2038 Australia Level 1, 335 - 341 Glebe Point Road (Cnr Ferry Rd),Glebe, Sydney, NSW AUSTRALIA Phone: + 61 2 96608027 Fax: + 61 2 96608106 Email: robert@robert-forbes.com.au Website: www.robert-forbes.com.au	Regulatory advice / Submissions Good Manufacturing Practice (GMP) services. Advertising compliance assessment Formulation advice Cosmetic product development Marketing assistance Technical writing Specialising in complementary medicines
Maureen Roberts Medconsult Services Ltd 46 Braemar Road, Rothesay Bay P O Box 35-927 Browns Bay AUCKLAND Phone: + 64 9 478 7776 Mobile: + 21 68 77 60 Fax: + 64 9 478 7731 Email: maureenroberts@xtra.co.nz	Regulatory Affairs services:- ethical, generic & OTC medicine applications complementary medicine applications strategic advice advertising compliance assessment labelling, datasheets, CMI WAND/DEAL applications COMET/ELF applications QA assistance
Sharyn Roberts (RN) Principal Consultant - Listings and Devices Regulatory Concepts Pty Ltd Unit 9, 7 Anella Ave Castle Hill NSW 2154 Australia Ph: +61 2 9846 1908 Fax: +61 2 9846 1930 E-Mail: sharynr@regcon.com.au Web: www.regcon.com.au	Listings Clinical Sponsorship Export applications Dietary supplements Foods Cosmetics Device applications
Jennifer Roodt Audit 4you PO Box 79333 Royal Heights 0656 AUCKLAND Phone: +64 9 412 9146 Fax: +64 021 960455 Mobile: +64 021 960455 E-mail: jenny@audit4you.biz Web site: http://www.audit4you.biz	Audit4you offers consultancy services using a pragmatic approach to : Quality systems GMP/GLP and Regulatory Compliance Documentation and SOP preparation Validation (process, cleaning and analytical method) Equipment qualification Continuous improvement Auditing and CAPA Process management
Edith Rosenberg Phone: (09) 524 7475 Mobile: (021) 630 600 E-Mail: edith.rosenberg@datastor.co.nz	CMI and Data Sheet writing Product information for health professionals, representatives or consumers Marketing of OTC and prescription products Promotional material advice Product Training Regulatory Affairs Service
Dr Sachin Samant Nutravision Consultancy Services Ltd 4/2 Kellow Place Manukau P O Box 64098 Botany Town Center Auckland NEW ZEALAND Phone: 09 263 8699 / 09 537 2696 Fax: 09 263 9496 Mobile: 027 213 2132 E-mail: info@biotechsolutions.co.nz	Broad Technical Services to Pharmaceutical, Nutraceutical, Functional Food & Beverage Industries. Quality Systems / Documentation - Design & Introduction GMP Quality Systems - SOP / Product Specifications Write Up - Internal Audit Plan / GMP Staff Training Program Validation / Qualification - Master Validation Plan - Manufacturing Facility Project Management - Equipment Commissioning, DQ, IQ, OQ - Process / Cleaning / Analytical Method Validation Product Development - New Product / Process Development - Product Support Scientific Literature Write up
Mateen Siddiqui GMP Consultancy Services Ltd. 20 Ulster Road Blockhouse Bay. Auckland. Phone: 021 102 6645 Email: mateen_siddiqui@hotmail.com or mateen.siddiqui@yahoo.co.nz	Technical & Regulatory Services to Pharmaceutical, Nutraceutical, Dairy and Food Industries New Facilities Design, Development & Management cGMP Quality Systems & Regulatory Support: Documentations / SOP / Site Master File / Specifications Internal Audits Staff Training Validations: Master Validation Plan / Process / Cleaning Qualifications: Equipment Design & Commissioning DQ / IQ / OQ Process, Operation development and improvement New Product Development
Joanna Strickland Strictly Clinical PO Box 17668 Sumner CHRISTCHURCH Phone/fax: (03) 326 5369 Mobile: (025) 226 4483 E-mail: jstrickland@cyberxpress.co.nz	Regulatory Clinical research
Gary Syme Medquest Consulting 31 Ponderosa Drive Albany Auckland 0632 Ph: 09 479 2212 Mobile: 027 3584707 Email: medquest@actrix.co.nz	23 years experience providing advice on: Medicines, Controlled Drugs, Dietary Supplements, Cosmetics, Devices Where your product fits Import, Export, Distribution, Possession, Storage, Advertising What you can do. What you can't do What you can say. What you can't say If not me where do you go for help How to write documents that meet requirements
Therapeutic Advertising Pre-Vetting System (TAPS) Association of New Zealand Advertisers Inc. P O Box 9348 Newmarket AUCKLAND Phone: (09) 300 5932 Fax: (09) 300 5931 E-mail: anza@anza.co.nz TAPS Consultant - Nigel J Andrews Phone: (09) 836 2680 Fax: (09) 837 5057 E-mail: njandrews@xtra.co.nz TAPS Consultant – Peter Pratt Phone : (04) 938 6409 Fax : (04) 934 6409 E-mail : peterpratt@paradise.net.nz Mobile : (027) 4921230	Advice on all aspects of advertising therapeutic products covered by: The ASA Code for Therapeutic Advertising The Medicines Legislation Industry Codes of practice
John Timmins Director of Regulatory Affairs - Asia Pacific Omnicare Clinical Research Pty Ltd Ground Floor, 13-15 Lyon Park Road North Ryde NSW 2113 AUSTRALIA	Regulatory Affairs Services: Medsafe and TGA liason Dossier gap analysis and preparation Literature based submissions Generic applications Prescription, OTC, complementary medicines Medical devices Cosmetics and toiletries AQIS permits NICNAS applications Clinical trial applications Asia Pacific, EU and USA regulatory authority experience Clinical Services: Clinical research phase I – IV Project management Data management and statistics
Mike Thompson Ethos Consulting Group 33 Old Hautere Road Te Horo RD2 Otaki 5582 NEW ZEALAND Phone: (06) 364 3913 Fax: (06) 364 3914 Mobile: (021) 364 391 E-mail: mike.thompson@paradise.net.nz	Regulatory Clinical research Medical & technical writing Specialist advice on strategic and pharmaceutical policy issues
Mike Thornber Health Audit New Zealand Ltd and the DAA Group PO Box 38610 Howick Auckland Mobile: (0274) 977833 Fax: (09) 5328023 Email: haudit@ihug.co.nz	Quality management audits & consultancy Clinical trial monitoring Site identification & investigator selection GMP advice & assistance SOP preparation Auditor training
Trident Clinical Research Pty Ltd Dr Merrîcc Edgar-Hughes, Head of Regulatory Affairs Department Head office : 124 Lipson St, Port Adelaide, SA, 5015, Australia Branch Offices in Sydney, Melbourne and Brisbane Phone: +61 8 8447 3500 Fax: +61 8 8447 3511 Email: info@tridentcr.com Website: www.tridentclinicalresearch.com	Trident’s Regulatory Affairs Department offers services for medicines, devices and biologicals including; Applications to register medicines in New Zealand (and Australia), including new chemical entities (synthetic and biological). Notifications on the WAND database in New Zealand and applications to include Class I – III medical devices on the Australian Register of Therapeutic Goods, including conformity assessment submissions, in Australia. Regulatory strategy development and advice for clinical to post-marketing phases. Product maintenance submissions including extension of indications, transfer of registrations, changed medicine notifications (NZ) and Category 3 applications/notifications (Australia). Literature based submissions Liaison with regulatory agencies Regulatory gap analysis and feasibility studies Critical review of data Orphan drug submissions (Australia) EAN Barcode applications (Australia) AQIS submissions (Australia) Trident Clinical Research provides services throughout Australia, New Zealand and India. Our Regulatory Affairs Department has the ability to thoroughly research, analyse situations, propose creative solutions and develop good interdisciplinary rapport. We can also assist you to set up regulatory affairs infrastructure in your organisation, such as SOPs, filing systems, position descriptions, etc. Trident also provides Clinical Research Project Management, Monitoring, Feasibility Assessments, Medical Monitoring, Local Safety Reporting, Data Management, Quality Assurance, Medical Writing and Training to the Pharmaceutical, Biotechnology and Device industries.
Virient Pty Ltd Anne Collins / Keith Smith 30-32 Stirling Street Thebarton SA5031 Australia Phone: +61 (0)8 8351 7902 Fax: +61 (0)8 8351 7902 Email: admin@virient.com Web: www.virient.com	Business and Product Strategy Planning Product Development Technical Development Quality Assurance Regulatory Compliance – GMP / GLP Regulatory Affairs Project Planning and Management Funding Strategies Expert Witness Due Diligence
Rob Warren Eden Consulting 4 Sharan Place Forestville Sydney NSW 2087 AUSTRALIA Phone: +61 2 9975 6205 Fax: +61 2 9975 6209 Email: eden@zipworld.com.au Web site: www.zipworld.com.au/~eden	GMP assistance to NZ, Australia TGA and International Standards GMP Audit assistance GMP Documentation packages Assistance with design of facilities GMP Staff Training Natural products Herbals, pharmaceuticals, devices Sterile and Non-Sterile products TGA Product Registrations
Mrs Susanne Winter Regulatory Concepts Pty Ltd Unit 9, 7 Anella Ave Castle Hill NSW 2154 Australia Ph: +61 2 9846 1903 Fax: +61 2 9846 1930 Web: www.regcon.com.au	Medical and Therapeutic devices in Australia and NZ, Foods and Listed medicines
Dr Dilruba Yasmeen Principal Regulatory Consultant Yasmeen & Associates 4 Chapel Court Doncaster VIC 3108 Australia Phone: +61 3 9848 4770 Mobile: +61 (0)409 144 036 Email: dyasmeen@bigpond.net.au	Registration and maintenance of registration of prescription medicines (pharmaceutical, biological, and blood products); Advice on regulatory affairs issues, and strategic regulatory planning; Review of dossiers; Due diligence activities relating to regulatory affairs for product licensing; Scientific report writing.

REGULATORY INFORMATION

Regulatory Consultants