Revised: 5 February 2024

Information for Industry

Regulatory Consultants

Medsafe has been informed that the following people provide independent regulatory, clinical and other consultancy services to the therapeutic products sector in New Zealand (as of November 2012). These people work independently of 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.

Company Services

360 Pharma Consulting Services Pty Ltd
Megan Polidano
Phone: +61 412864 131
Email: 360pharmaconsulting@gmail.com

Applications for new/changed medicines (Prescription and OTC)
Applications for new/changed related products (Prescription and OTC)
Medical devices
Regulatory  strategies
Project management
Applications for transfer/rescheduling of medicines  
Good Manufacturing Practice 
Accelagen Pty Ltd
Offices in Australia and New Zealand
Phone: +61 3 9114 2270
Email: info@accelagen.com.au
Web: www.accelagen.com.au
Applications for new/changed medicines (Prescription and OTC)
Applications for new/changed related products (Prescription and OTC)
Medical devices
Regulatory and commercialisation strategies
Market access – Reimbursement strategies
Competitor analysis & market insights
Pharmacovigilance
Risk management
Clinical development
Clinical trials
Good Manufacturing Practice
Auditing
Recalls
Advertising
Adjutor Healthcare Group
Offices in Australia and New Zealand
Joseph Badolato PhD - Senior Business Development Manager
Phone: +61 (0)410467573
Email: contact@adjutor.com.au
Web: https://www.adjutor.com.au
Advertising
Applications for new/changed prescription medicines
Applications for transfer/rescheduling of medicines 
Auditing 
Clinical trials
Commercialisation strategies
Competitor analysis & market insights
Device vigilance and reporting
Due diligence
Gap analysis
Good Laboratory Practice (GLP)
Good Manufacturing Practice (GMP)
In vitro diagnostics (IVDs)
ISO 13485 
Market access & reimbursement
Medical affairs
Medical devices
Medical information
Medical writing
Pharmacovigilance & adverse event reporting
Prescription medicines
Project management
Quality Management Systems - development & audits
Recalls
Regulatory submissions - local and international
Regulatory submissions - medicines and devices
Risk management
Small to large companies, tailored services for startups
Sponsorship - medicines and devices
Strategy - concept to commercialisation
Strategy - local and international
Technical & scientific writing
Training
ADVANTAGE Medical products Consulting Pty Ltd
Unit 204/1013 Gold Coast Highway
Palm Beach
QLD 4221
AUSTRALIA
Brenley M MILSOM
Phone: +61 7 55224880
Mobile +61 (0) 407533048
E-mail: bmilsom@advantagempc.com.au
Web: www.advantagempc.com.au
Applications for new/changed medicines
Applications for new/changed related products
Medical devices
Good Manufacturing Practice
Pharmacovigilance
Advertising
All Biomedical Engineering and Regulatory Specialist Services
Ruth Grant
Phone: 04 5278793
Mobile: 021313169
E-mail: regrantnz@yahoo.com
Advertising
Applications for new/changed related products
Clinical trials
Good Manufacturing Practice
Medical devices
APPharma Consulting Pty Ltd
PO Box 2046, Normanhurst, NSW 2076, AUSTRALIA
Jeff Song
Phone: +61 401 091 878
Email: jeff.song@appharma.com.au
Web: www.appharma.com.au
Applications for new/changed medicines
Applications for new/changed related products
Applications for rescheduling of medicines
Good Manufacturing Practice
Advertising
AnQual GLP Laboratories
School of Pharmacy, The University of Auckland
A/Prof. Sanjay Garg
Phone: (09) 373 7599 ext 82836
E-mail: s.garg@auckland.ac.nz
Web: http://www.fmhs.auckland.ac.nz/sop/anqual/
Applications for new/changed medicines
Applications for new/changed related products
Medical devices
Clinical Trials
Good Manufacturing Practice
Archer Emery & Associates
PO Box 7136, Yarralumla, ACT 2600, Australia
Paul Archer, Julie Emery
Phone: +61 2 6281 3873
E-mail: parcher@archeremery.com.au
Web: www.archeremery.com.au
Applications for new/changed medicines
Applications for new/changed related products
Medical devices
Clinical Trials
Good Manufacturing Practice
Pharmacovigilance
Advertising

Avani Goswami Consulting
Puninga Lane Takanini 2112, Auckland, New Zealand
Mobile : 0064 221537249
E-mail : avanjit1@gmail.com

Applications for new/changed medicines
Applications for new/changed related products
Medical devices
Good Manufacturing Practice
Pharmaceutical Software Services
BELTAS™ Ltd
PO Box 99 728, Newmarket 1149 AUCKLAND
Gerard Dunne
Phone: (09) 520 2410
E-mail: contact.health@beltas.com
Web: www.beltas.com
Medical devices
Clinical Trials
Pharmacovigilance
BioEquitas Ltd
Samantha Gray
Phone:  021 1197226
E-mail:  samantha@bioequitas.co.nz  
Web: www.bioequitas.co.nz
Dietary Supplements
Food/Dietary Supplement Interface
Supplemented Foods Regulations
Foods Regulations and Health Claims
Self-Substantiated Health Claims Dossiers
Hemp & CBD
Advertising inc Digital and Social Media
Label Compliance & Copy
Product Development – concept to commercialisation
Global Market Regulatory Strategies - including:
TGA Australia Complementary Medicines
US FDA 21 CFR 111 Dietary Supplements
Competitor Analysis & Market Insights
Levels of Evidence Strategy
R&D project management and cofunding
Project Management & Trials
Technical Troubleshooting - in process & analytical
Technical & Scientific Writing
Commercialisation Strategies
Good Manufacturing Practice
Auditing and Gap Analysis
Good Laboratory Practice
Analytical Methods and Validation
Technical Due Dilligence
Small to Large Companies - tailored services for startups
Biotech Regulatory Solutions
Katy King
Principal Consultant
PO Box 51
Church Point NSW AUSTRALIA
Phone: + 61 2 9999 4770
E-mail: katy@biotechregulatory.com.au
Web: www.biotechregulatory.com.au
Applications for new/changed medicines
Applications for new/changed related products
Applications for rescheduling of medicines
Medical devices
Clinical trials
Good Manufacturing Practice
Device vigilance/reporting
Due diligence on dossiers or life cycle of products
Gap analysis
Medical affairs
Medical information
Medical writing
Pharmacovigilance
Prescription medicines
Project management
Quality Management Systems
Recalls
Risk management
Sponsorship
Strategy
Dossier writing and publication (eCTD and NeeS)
Training
Biotec Solutions Limited
35 Roscommon Road, Manukau, Auckland,
Dr. Sachin Samant
Phone: (09) 2789496
E-mail: Sachin@biotecsolutions.co.nz
Web: www.biotecsolutions.co.nz
Good Manufacturing Practice
Brigid Glass & Associates Ltd
Brigid Glass, Consultant and Coach
43 Campbell Rd, Maraetai, Auckland 2018
PO Box 281030, Maraetai Beach, Auckland 2148
Phone: +64 9 535 3119
E-mail: brigid.glass@brigidglassassociates.net
Web: http://nz.linkedin.com/in/brigidglass
Medical Devices
Caduceus Medical Development, Ltd
Tara M. Creaven-Capasso, MAppSc., RQAP-GLP, RAC Founding Partner / Managing Director
16 Ihaka Street
Palmerston North 4410
Phone: +64 (0) 21 623005
Email: tcreaven@caduceus-consulting.com
Medicinal Cannabis
Medical Devices
Pharmaceutical Medicines
Device and Medicines Sponsorship 
Good Manufacturing Practice
ISO 13485 
ISO 17025 
Quality Management Systems
Auditing 
Applications for new/changed medicines 
Applications for transfer/rescheduling of medicines 
Regulatory strategy development
Commercialisation strategies 
Advertising
Cameron Healthcare Ltd
Helen Teale, Managing Director
8/137 Jervois Road, Herne Bay, Auckland 1011
PO Box 46096, Herne Bay, Auckland 1147
Phone: +64 9 360 8528
Mobile: +64 21 738 205
E-mail: helen@cameronhealthcare.co.nz
Web: www.cameronhealthcare.co.nz
Clinical Trials
Medical Devices
Applications for new/changed medications
Pharmacovigilance
Advertising
Medical Writing
Caroline Norwood Consulting
15 Empire Road, Devonport, Auckland 0624, NZ
Caroline Norwood
Mobile: +64 21 378 445
Email: c.norwood@outlook.com
Applications for new/changed medicines
Medical devices
CARSL Consulting
24 Side Road, Parkhill Farm, RD10, Hastings
PO Box 766, Hastings
Brian Day
Phone: (06) 875 0979
E-mail: carsl@xtra.co.nz
Web: www.carsl.co.nz
Applications for new/changed medicines
Applications for new/changed related products
Medical devices
Clinical Trials
Good Manufacturing Practice
Pharmacovigilance
Advertising
Device and Medicines Sponsorship
Cassandra Hogan
Fontein Professional Services
Email:  cassandra@fonteinccs.co.nz

Medical Writing
Technical Writing
Quality Management Systems
Auditing
Pharmacovigilance & Adverse Event Reporting

Category 1 Pharma Consulting Pty Ltd
Kingsville
Victoria
Australia
Phone: + 61 412 800 845
Email:  info@category1pharma.com
Web: www.category1pharma.com
Applications for new/changed medicines
Applications for new/changed related products
Applications for rescheduling of medicines
Medical devices
Good Manufacturing Practice
Commercial Eyes Pty Ltd
Level 11, 500 Collins Street
Melbourne VIC 3000, AUSTRALIA
Phone: +61 3 9251 0777
E-mail: : info@commercialeyes.com.au
Web: http://commercialeyes.com.au/
Applications for new/changed medicines (Prescription and OTC)
Applications for new/changed related products (Prescription and OTC)
Medical devices
Regulatory and commercialisation strategies
Market access – Reimbursement strategies
Market insight
Pharmacovigilance & risk management
Medical Information
Medical Affairs
Advertising
Clinical development
Dietary supplements
Good Manufacturing Practice
Rosalind Dalefield PhD DABT DABVT
Phone: 027 543 6668
E-mail: rosalind@dalefield.com
Web: http://www.toxi.co.nz
Applications for new/changed medicines
Preclinical trials
Preclinical Good Laboratory Practice
e-MAS Medicine Advertising Service
Emi Gosling (principal consultant & pharmacist)
Sydney, Australia
Phone: +61 (0)2 9484 3336
Mobile: +61 (0) 43 838 2505
Email: Emi@e-MAS.com.au

Web: www.e-MAS.com.au

Advertising – Compliance (Consumer)
Advertising – Advisory (OTC, Complementary Meds, devices)
Digital and Social Media advertising
Medicine Interface – Foods and Cosmetic
D-T-C Medical Writing Training
Engel, Hellyer &Partners Pty Limited
Level 4, 815 Pacific Highway, Chatswood, NSW 1515, Australia
PO Box 5462, West Chatswood NSW 1515, Australia
Dr Graeme Haley, Sandie Rooke, Ray Maio
Phone: +61 2 9413 9799
E-mail: enquiries@engelhellyer.com
Web: www.engelhellyer.com
Applications for new/changed medicines
Applications for new/changed related products
Medical devices
Good Manufacturing Practice
Advertising
ERA Consulting
Level 3, 88 Jephson Street,
Toowong, QLD 4066, Australia
Mr Tristan Elliott
Phone: +61 (7) 3331 3900
E-mail:  info@eraconsulting.com
Web: www.eraconsulting.com
Applications for new/changed medicines
Clinical trials
Ethos Consulting Group
33 Old Hautere Road, Te Horo, RD2, OTAKI 5582
Mike Thompson
Phone:  (06) 364 3912 & (021) 364 391
Email:  mike.ethos@gmail.com
Applications for new/changed medicines
Applications for new/changed related products
Applications for rescheduling of medicines
Medical devices
Clinical Trials
Advertising

Gallandeer Ridge Pty Ltd
PO Box 7068, Wilberforce, NSW Australia 2756
Jocelyn Thompson
Phone:  +61 418 258 847
Email:  info@grpharmaconsult.com
Web:  www.grpharmaconsult.com

Applications for new/changed medicines

Applications for new/changed related products
Medical devices
Good manufacturing practice
Medical writing

Erin Gentry B.Pharm(Hons), MPS, RegPharmNZ
ThirtyThree, PO Box 74166, Greenlane, Auckland 1546
Email: erin@thirtythree.co.nz
Web: www.nz.linkedin.com/in/eringentry3
Advertising
Medical Writing and Medical Information
Pharmacovigilance
Global Compliance (International) Ltd
7 Grant Avenue, Russell, Bay of Islands
Ashley Hankinson
Phone: +64 9 4037897
Mobile: +64 210 77898 and
+44 7788720621
E-mail: Ashley@nordiccomplianceservices.com
Web: www.nordiccomplianceservices.com
Applications for new/changed medicines
Applications for new/changed related products
Medical devices
Good Manufacturing Practice
GMP Consultancy Services Limited
73- Fruitvale Road, New Lynn. Auckland
Mateen Siddiqui
Phone: (09) 8264474, mob 021 252 1855
E-mail: Mateen.siddiqui@yahoo.co.nz
Good Manufacturing Practice

Grayson Wagner Consulting Limited
4 Cain Rd, Penrose, Auckland 1061
Email: info@graysonwagner.co.nz
Web:  www.graysonwagner.co.nz

Technical & Scientific Writing
Medical Devices
Pharmaceutical Medicines, Regulatory and commercialisation Strategies- Services including compliance checks for:

  • Ingredient and formulation
  • Label
  • Claims
  • Import/export requirements
  • Overseas product registration
  • Dossier writing
Global regulatory launch strategy covering overseas markets such as Australia, USA, UK, UK, Singapore, and Malaysia etc
Green Lane Coordinating Centre
Level 1, 2163 Great North Road, Avondale, Auckland, New Zealand
Olga Bucan
Phone: (09) 820 2050
E-mail: contact@glcc.org.nz
Web: www.glcc.org.nz
Clinical Trials
Hannah Temple Consulting
7 Makomako Road, Brooklyn, Wellington 6021
Hannah Temple
Mobile: 021 298 9092
E-mail: hannah.temple2@gmail.com
Applications for new/changed medicines
Applications for new/changed related products
Medical devices
Advertising
Health Audit NZ Limited
PO Box 38610,Howick, Manukau 2145
Mike Thornber
Phone: 0274 977833
E-mail: haudit@ihug.co.nz
Clinical Trials
Good Manufacturing Practice
InsightReg Consultancy
Elvina Hsi
Phone: +64 204 358462
Email: elvina.hsi@insightregulatory.co.nz

Regulatory compliance and strategy from concept, product development to commercialisation covering the following classifications:

  • Food
  • Supplemented Food
  • Dietary Supplement
  • Food/Supplement/Drug/Cosmetic interface

Services including compliance checks for:

  • Ingredient and formulation
  • Label
  • Claims
  • Advertising (offline and online)  
  • Import/export requirements
  • Overseas product registration

Global regulatory launch strategy covering overseas markets such as Australia, USA, UK, China, Hong Kong, Singapore and Malaysia etc.

Fluent in both English and Mandarin.

International Certifications Limited
30 Bishopsgate Business Centre, Bishop Dunn Pl, Botany South, Auckland
Dave Evans
Phone: (09) 273 4099 or 0800 ISO 9001
E-mail: admin@intlcert.com
Web: www.intlcert.com
Medical devices
Good Manufacturing Practice
Johner Institute
Anne Arndt
Director
Engineering Building, Level 1
2 Worcester Boulevard
Christchurch 8013
Phone: +64 (0) 20 41831943
E-mail: Annett.Arndt@Johner-Institut.co.nz 

Active Medical Devices

Software as Medical Device

Expert witness for Software as Medical Device (No. 1-22-1016)

Regulatory strategy development (FDA, EU, TGA) Quality Management System according to ISO 13485 and FDA 21 CFR 820

Technical Dossier / Design Controls / Design Dossier according to requirements TGA, EU, FDA and according to

  • Medical Device Regulation (EU 2017/745)
  • Software Development (IEC 62304)
  • Risk Management (ISO 14971) incl. Cyber Security
  • Usability Engineering (IEC 62366)
  • Electric Safety (IEC 60601-x)
  • Biocompatibility (ISO 10993-x)

Surveillance activities required by the authorities or standards

  • Regulatory Radar (monitoring of the regulations)
  • Post Market Radar (MDR/IVDR/ISO 20416-compliant post-market surveillance)
KD & A Pty Limited
Phone:  0411 101 392
Email:  kdent@kdas.com.au
Web:  www.kdas.com.au
Medical devices
Keene Manufacturing Solutions
59 John Gill Rd, Howick, Auckland
Richard Keene
Phone: (09) 534 5347, 021 278 1845
E-mail: keeneman@xtra.co.nz
Good Manufacturing Practice
System and Supplier Auditing
Dietary Supplements
Quality System Development
Recalls
GMP Training
Keith Holmes Consulting
50 Sartors Avenue, Browns Bay, Auckland 0630
Dr Keith Holmes
Phone:  (09) 476-8082
Mobile:  027 276 8082
E-mail:  keith.holmes@ihug.co.nz
Applications for new/changed medicines
Applications for new/changed related products
Applications for rescheduling of medicines
Medical devices
Clinical trials
Good Manufacturing Practice
Pharmacovigilance
Advertising
Kim Walker Consulting
Kim Walker, MS, RAC (US & EU)
Global RA & QA Consultant
Skype Contact: kwconsulting
Email: kwconsulting@socal.rr.com or kim@kimwalkerconsulting.com
Web: www.kimwalkerconsulting.com
Advertising
Applications for New/Changed Medical Products
Clinical Trials
Dietary Supplements
Good Laboratory Practice
Good Manufacturing Practice & Quality System Development/Audits
Labelling
Medical Devices & IVDs
Medical Writing
Pharmacovigilance & Adverse Event Reporting
Prescription & OTC Medicines
Recalls
Training
Medconsult Limited
46 Braemar Road, Rothesay Bay, Auckland 0630
PO Box 35-927, Browns Bay, Auckland 0753
Maureen Roberts
Phone: (09) 478 7776
Mobile: 021 68 77 60
Fax: 09 478 7731
E-mail: maureenroberts@xtra.co.nz
Applications for new/changed medicines
Applications for new/changed related products
Medical devices
Good Manufacturing Practice
Pharmacovigilance
Advertising
MediNova Ltd
7 Grant Avenue, Russell, Bay of Islands
Ashley Hankinson
Phone: +64 9 4037897
Mobile: +64 210 778987
E-mail: Ashley@mdnova.com
Web: www.nordiccomplianceservices.com
Applications for new/changed medicines
Applications for new/changed related products
Applications for rescheduling of medicines
Medical devices
Clinical trials
Good Manufacturing Practice
Pharmacovigilance
MSR Consultancy Ltd
Richard Mayfield
Phone: +64 (0)9 427 9987
Fax +64 (0)9 427 9987
Mobile 021 628 379
E-mail: richard.mayfield@xtra.co.nz
Preclinical trials
Preclinical Good Laboratory Practice
MTA Pharma Consulting
PO BOX 1210
Glen Waverley
Victoria 3150
Australia
Contact: Mark Mariathas
email:kmariath@tpg.com.au
mobile: + 61 413325697
Applications for new/changed medicines
Good Manufacturing Practice
Advertising
Neon Consulting
Chris Mander
40B Howe Street, Howick, Auckland 2014 
Phone: 021 0249 4240
Email: neon@xtra.co.nz
Medical devices
New Wayz Consulting Ltd
P.O. Box 36-496, Northcote 0748 Auckland
Maurice Parlane
Phone: (09) 419 8029
E-mail: info@newwayz.co.nz
Web: http://www.newwayz.co.nz
Applications for new/changed medicines
Applications for new/changed related products
Medical devices
Good Manufacturing Practice
Nordic Compliance Services Ltd
PO Box 119
Russell
Bay of Islands
0242
Phone: +64210778987
E-mail: ashley@nordiccomplianceservices.com
Web: www.nordiccomplianceservices.com
Applications for new/changed medicines
Applications for new/changed related products
Medical devices
Good Manufacturing Practice
Pharmacovigilance

Pharma To Market Pty Ltd
Nick Ward
Co-Director
Level 1, 7 Clunies-Ross Court
Brisbane Technology Park
Eight Mile Plains QLD 4113
Australia
Phone: +61 (0)7 3122 9979
Mobile: +61 (0)406 606 036
E-mail: nick.ward@pharmatomarket.com
Web: www.pharmatomarket.com

Applications for new/changed medicines
Applications for new/changed related products
Good Manufacturing Practice
Medical Writing
Electronic Submissions
Training

Pharmaceutical Solutions Limited
Level 1, The Levy Building, 20 Customs Street East
Britomart Business Precinct
Auckland 1010
Linda Hill
Phone: +64 9 379 8205
Fax +64 9 379 8244
Web: www.pharmasols.com
Advertising
Applications for new/changed medicines
Applications for new/changed related products
Applications for rescheduling of medicines
Clinical trials
Good Manufacturing Practice
Medical devices
Medical writing
Pharmacovigilance
PharmAffairs Regulatory Services Limited
29 James Evans Drive, Northcote, Auckland 0627
Pauline Harris
Phone: (09) 419 9451
Mobile: 021 185 0566
Applications for new/changed medicines
Applications for new/changed related products
PharmaLex Pty Ltd
Level 10, 1 Chandos Street, St Leonards NSW 2085 Australia
Phone: +61 2 9906 2984
Mobile: +61 467 629 317
Email: enquiries.au@pharmalex.com
Web: www.pharmalex.com 
Applications for new/changed medicines (OTC and Prescription) Applications for new/changed related medicines
Electronic Submissions
Applications for reclassification of medicines
Clinical Trials
Good Manufacturing Practice
Research and Development Support
Regulatory and commercialisation Strategies
Pharmacovigilance
Medical Information
Materials Compliance Review
Patient Programs
Philippa Davies and Partners Consulting
Philippa Davies BPharm, RegPharmNZ, MPS, PG DipBusAdmin
Mobile: +64 21 1756590
Email: philippadavies27@outlook.com
Web: https://www.linkedin.com/in/philippa-davies-16830336/
Regulatory strategic advice
Market access strategic advice
Advertising (prescription, OTC, dietary supplements)
Compliance with industry and advertising codes of practice
Medicines Classification Committee submissions
Medical Affairs Business planning
Business cases (BBC trained)
Project Management
Quality Associates
a Division of Tranzsoft Group Ltd
PO Box 303-190, North Harbour
AUCKLAND,
Phone: (09) 448 2075
Fax (09) 448 1371
Mobile (Steve) (027) 561 2292
E-mail: steve@qai.co.nz
Web: www.qai.co.nz
Good Manufacturing Practice
Qudos
Shirlene Moore
Phone:  +64 (0) 204 122 6365
E-mail: shirlene.moore@qudos.co.nz
Website:  https://www.qudos.co.nz
 
Good Manufacturing Practice
GxP (Good Laboratory Practice, Good Wholesaling Practice etc.)
Auditing
Recalls
Gap Analysis 
Quality System Setup
Dietary Supplements, Medicines
GxP Training
Technical writing (Technical Reports, SOPs)
R-Line Limited trading as Foodaction
Phill Dromgool
Phone: 027 575 3348
Freephone: 0800 475 463
Email: phill@foodaction.co.nz
Web: www.foodaction.co.nz
Food/Dietary Supplement Interface
Dietary Supplement Formulation
Dietary Supplement Labelling
Supplemented Food Labelling
Supplemented Food Formulation
Health and Nutrition Claims
TAPS Submissions
Exporting of dietary supplements
Self Substantiated Health Claims
Novel Foods
Reg IQ Pty Ltd
Carnegie VIC 3163 Australia
Natasha Tepic
Director
Phone: +61 409 183 594
Email:natasha@regiq.com.au
Web: www.regiq.com.au
Medicines:
  • Applications for new/changed medicines
  • Applications for new/changed related products
  • Applications for rescheduling of medicines
Medical devices

Food & beverages:
  • Health and nutrition claims
  • Self-Substantiated Health claims
  • Novel Foods
Dietary supplements
Regulatory & commercialisation strategies
Gap analysis
Dossier writing
Technical report writing
Recalls
Regulatory Concepts Pty Ltd
9/7 Anella Ave, Castle Hill, NSW 2154, Australia
Dr. Helena Dickenson
Phone: +61 (0) 2 9846 1900
E-mail: helenad@regcon.com.au, info@regcon.com.au
Web: www.regcon.com.au
Applications for new/changed medicines
Applications for new/changed related products
Medical devices
Good Manufacturing Practice
Advertising
Regulatory Par Excellence
Laurence Garceau
Director and Principal Consultant
3/76 Merlin Street, Neutral Bay NSW 2086 Australia
Phone: + 61 415 706 915
E-mail: laurence.garceau@regexcel.com
Website: www.regexcel.com
Applications for new/changed medicines
Applications for new/changed related products
Medical devices
Clinical trials
Research Associates Limited
P.O.Box 17-539, Christchurch,
Tony Mann
Phone: 021 713671
E-mail: tony@ral-nz.com
Web: www.ral-nz.com
Clinical Trials
Revio Pharmaceutical Consultants, S.L.U.
Phone: +34 656 659 636
Email:  regaffairs@reviopharma.com
Website:   www.reviopharma.com
Regulatory strategy and submissions
Regulatory Strategy and Roadmaps.
Regulatory Preparation & Submissions: CTA, IND, IMPD, IB, MAA, NDA/BLA, DMF, ASMF, etc.
Regulatory Agency Interaction: Scientific Advice (EMA and national), FDA meetings, ITF meetings, EMA/HTA parallel consultation, PRIME, BTD, RMAT, Orphan Drug Designation, PIP/PSP.
Regulatory Lifecycle Management.
Other regulatory activities: ATMP classification and certification, SME status.
Due diligence
Inlicence.
Outlicence.
CMC, Non-clinical and Clinical
Strategic development.
Revision/writing CMC, NC and C documents.
Review clinical protocols, FIH, Exploratory and Confirmatory.
Agency meeting preparation and attendance.
Draft/review CMC, nonclinical and clinical data, defend and review company position.
CMC Technical Advisory
Manufacturing and Quality.
Analytical Method Development/Validation.
Potency Assay strategy.
Release and Stability testing, Specifications.
Process Development and Validation, QbD.Identification of CMO, Technology Transfer and Comparability
Right Time Business Pty Limited
PO Box 55 Glen Iris Victoria 3146 Melbourne Australia
Roy Hardman
Phone: +61 3 98855388, +61 419 100 978
E-mail: roy@righttimebusiness.com.au
Web: www.righttimebusiness.com.au
Medical devices
Robert Forbes and Associates
Level 1, 335-341 Glebe, Point Rd (cnr Ferry Rd), Glebe (Sydney) NSW 2037 Australia
Robert Forbes
Phone: +61 2 96608027
E-mail: RFAinfo@robert-forbes.com
Web: www.robert-forbes.com
Applications for new/changed medicines
Applications for new/changed related products
Good Manufacturing Practice
Advertising
Scientific & Regulatory Solutions
Sydney, Australia
Contact:  Jim Moshovelis
Mobile:  +61 406 948 498
Email:  info@sciregsolutions.com.au
Web:  www.sciregsolutions.com.au
Applications for new/changed medicines
Applications for new/changed related products
Good Manufacturing Practice
Quality Management / Systems Audits
Regulatory & Commercialisation Strategies
Dietary Supplements
Food & Beverages
Training
Spectrum Technology Pty Limited
P.O. Box 422 Glenhuntly Victoria 3163 Australia
Harry Pose
Phone: +613 9578 1420
E-mail: h.pose@bigpond.com
Web: www.harrypose.com
Applications for new/changed related products
Medical devices
Good Manufacturing Practice
Statistecol Consultants Limited
51 Woodside Rd, Mt Eden
Auckland
Chris Frampton
Phone: 0272729378
E-mail: statistecol@xtra.co.nz
Applications for new/changed medicines
Clinical trials
The SPD Company Pty Ltd
Renée Simon
Business Manager
NZ and Australia
Mobile: +61 402 546 792
E-mail: enquiries@theSPDcompany.com.au
Pharmaceuticals, Medical Devices and Biotechnology. New Zealand, Australia, Europe, US.
  • Regulatory – New submissions, line extensions, WAND, Advertising review.
  • Quality – ISO audits, QMS upgrade/implementation.
  • Pharmacovigilance – pharmaceuticals and devices.
  • Product development – concept development stages to commercialisation.
    Advertising review.
Close association with Clinical Research and Reimbursement organisations.
Therapeutic Advertising pre-Vetting System (TAPS) Adjudicator
96 Hazelwood Ave, Karori, Wellington 6012
Peter Pratt
Phone: (04) 938 6409
E-mail: peterpratt@paradise.net.nz
Web: www.anza.co.nz
Advertising
Therapeutic Advertising pre-Vetting System (TAPS) Adjudicator
Nicola Pearce
Mobile: 021 645575
Email: nicolapearcetaps@xtra.co.nz
Web: www.anza.co.nz
Advertising
Therapeutic Advertising Pre-Vetting System (TAPS) Co. Association of New Zealand Advertisers Inc.

46 Braemar Road, Rothesay Bay, Auckland 0630
PO Box 35-927, Browns Bay, Auckland 0753
Maureen Roberts
Phone: (09) 478 7776
Mobile: 021 68 77 60
Fax: 09 478 7731
E-mail: maureenroberts@xtra.co.nz
Web: www.anza.co.nz

Advertising
Value-Based Access Pty Ltd
ABN: 42 237 591 962; ACN: 161 694 195
PO Box 4369
Thornleigh, NSW 2120
Australia
Eugene Salole PhD MPH
Mobile: +61-409 041 976
E-mail: esalole@valuebasedaccess.com
Web: www.valuebasedaccess.com
LinkedIn: https://au.linkedin.com/in/eugene-salole-ab8ab732
Medical devices and diagnostics:
Health technology assessment (HTA)
Market access strategies
Value communication; Global Value Dossiers
Value-based 3rd-party funding propositions
‘Selling with evidence’: Sales and Marketing staff training in communicating product value
Local research studies to demonstrate product value
Stakeholder engagement
Weir Regulatory Consulting
83 Tania Ave, Palmwoods, QLD 4555, Australia
Jo Weir
Director and Principal Consultant
Phone: +61 428 144 267
E-mail: jo.weir@weirconsulting.com.au
Website: www.weirconsulting.com.au
Applications for new/changed medicines
Applications for new/changed related products
Applications for rescheduling of medicines
Medical devices
Good Manufacturing Practice
Advertising
Medical writing
Yasmeen & Associates
Apartment G03, 112 Waterdale Road, Ivanhoe, Victoria 3079, Australia
Dr Dilruba Yasmeen
Phone: +61 3 9848 4770 or +61 (0)409 144 036
E-mail: dyasmeen@bigpond.net.au
Applications for new/changed medicines
Applications for new/changed related products
Gap analysis
Dossier writing
Technical Report Writing
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