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 2008). 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
ADVANTAGE Medical products Consulting Pty Ltd 5 Yatama Place, Currumbin Waters, QLD 4223, AUSTRALIA Brenley MILSOM Phone: +61 7 55224880 Fax +61 7 55224128 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
Anderson Consulting & Contracting Ltd 66 Waiora Rd, Stanmore Bay, Whangaparaoa 0932 Nikki Anderson Phone: (09) 4240457 E-mail: warren_nikki@xtra.co.nz	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/default.aspx	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
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
Biotech Regulatory Solutions Katy King Principal Consultant PO Box 135 Church Point NSW AUSTRALIA Phone: + 61 2 9979 2180 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
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
Brandwood Biomedical Pty Ltd Arthur Brandwood, Managing Director Suite 408, 460 Pacific Highway St Leonards NSW 2065 Australia Phone Office: +61 (0)2 9906 2984 Fax: +61 (0)2 8580 4613 E-mail: enquiries@brandwoodbiomedical.com.au Web: www.brandwoodbiomedical.com.au	Medical devices Applications for new/changed medicines Applications for new/changed related products Applications for rescheduling of medicines Clinical trials Good Manufacturing Practice Pharmacovigilance Advertising
Carole Malcolmson Consulting 19 Maungakiekie Ave, Greenlane, Auckland Dr Carole Malcolmson Phone: (09) 524 0595, 021 524 059 E-mail: carole_malcolmson@hotmail.com	Applications for new/changed medicines Good Manufacturing Practice
CARSL Consulting 11 Mill Road, RD2, Pukekohe 2677 PO Box 480, Pukekohe2340 Brian Day Phone: (09) 2383447 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
DevDx Clinical Paul Cohen Managing Director Head Office: 408/460 Pacific Highway St Leonards, NSW, 2065, Australia Phone: + 61 2 9906 2984 Fax: + 61 2 8580 4613 Web: www.DevDxclinical.com	Applications for new/changed medicines Applications for new/changed related products Applications for rescheduling of medicines Medical devices Clinical trials
Edith Rosenberg 23 Mahoe Ave Remuera Auckland Phone:64 21 630 600 E-mail: edith.rosenberg@xtra.co.nz	Applications for new/changed medicines Applications for new/changed related products Pharmacovigilance Advertising Medical Writing
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 Mike Thompson Phone: (06) 364 3912 & (021) 364 391 E-mail: mike.thompson@paradise.net.nz	Applications for new/changed medicines Applications for new/changed related products Applications for rescheduling of medicine Medical devices Clinical Trials Advertising
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
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
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
HLS Innovations Limited P.O. Box 12-1365, Henderson, Auckland 0650 Ranjan Acharya Phone: (09) 816-8881 E-mail: enquiries@hlsinnovations.com Web: http://www.hlsinnovations.com/	Good Manufacturing Practice
In Vivo Communications Building E, 27-29 William Pickering Drive. Albany, North Shore City PO Box 300 667, Albany, North Shore City, 0752 Tricia Newell Phone: (09) 448-5408 E-mail: t.newell@invivocom.com Web: www.invivocom.com	Clinical Trials Advertising
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
KD & A Pty Limited Level 1, 251 Hutt Street, Adelaide, South Australia Kea Dent Phone: 0011 64 823 28358 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
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
Kendle Pty Limited (Australia) Judy Bingham - Senior Director Regulatory, Asia Pacific Level 1, 20 Atherton Road Oakleigh VIC 3166 Phone: + 61 3 9567 7600 Mobile: + 61 (0) 408002810 E-mail: bingham.judy@kendle.com Web: www.kendle.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
Medconsult Services Limited 46 Braemar Road, Rothesay Bay, Auckland 0630 P O 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@nordiccomplianceservices.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
Medra Services Limited PO Box 115, Feilding 4740 Graham Leslie Phone: (06) 3238573 0274 537543 E-mail: medra@xtra.co.nz	Applications for new/changed medicines Applications for new/changed related products Medical devices Good Manufacturing Practice Pharmacovigilance Advertising
Michelle Carbines Regulatory Consultant PO Box 224, Matakana 0948. Michelle Carbines Phone: (09) 423 8855 E-mail: mcarbines@slingshot.co.nz	Applications for new/changed medicines Applications for new/changed related products Applications for rescheduling of medicines Medical devices Clinical Trials Pharmacovigilance
Neon Consulting Chris Mander 7 Bain Place, Bucklands Beach, Manukau 2014, Auckland 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@mdnova.com Web: www.mdnova.com	Applications for new/changed medicines Applications for new/changed related products Medical devices Good Manufacturing Practice Pharmacovigilance
PCR Ltd New Zealand 24 Portsea Place, Chatswood, North Shore, Auckland 0626 Dr Felix S F Ram Phone: (+64) 021-1077729 E-mail: fsfram@yahoo.co.uk	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
Pharmaceutical Marketing NZ Ltd PO Box 105 535 AUCKLAND John Wickens Phone: +64 9 377 0660 E-mail: john@pharmamark.co.nz	Applications for new/changed medicines Applications for new/changed related products Applications for rescheduling of medicines Medical devices Advertising
Pharmaceutical Solutions Limited Level 2, 109-111 Quay St, Pier 1, Queens Wharf, Auckland 1010 Linda Hill Phone: (09) 3798205 E-mail: lindahill@pharma-solutions.co.nz Web: www.pharma-solutions.co.nz	Applications for new/changed medicines Medical devices Clinical Trials
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
Quality and Regulatory Services Limited [QRSL] PO Box 147, Kaukapakapa, 0843 Martyn Gillam Phone: (09) 420 4424 Mobile: 021 654 966 E-mail: qrslimited@gmail.com	Good Manufacturing Practice Applications for new/changed medicines Applications for new/changed related products
Quality Associates a Division of Tranzsoft Group Ltd P O 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
RAR Consulting Limited 63B Sierra Way, RD1, Upper Hutt Dr Ralph Richardson Phone: (04) 528 3201 Mobile: (022) 6774161 E-mail: rarcon@actrix.co.nz	Applications for new/changed medicines Applications for new/changed related products
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
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
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
Rob Allman Consulting 14 Spencer Street, Crofton Downs, Wellington Rob Allman Phone: (04) 4791029 Mobile 021 1024268 E-mail: rl.allman@xtra.co.nz	Applications for new/changed medicines Applications for new/changed related products Medical devices Good Manufacturing Practice
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
Saltarelo Limited P. O. Box 51-598, Pakuranga, Auckland Gillian Alexander Phone: (09) 533 7171 E-mail: Saltarelo@xtra.co.nz	Applications for new/changed medicines Applications for new/changed related products Applications for rescheduling of medicines Medical devices Pharmacovigilance Advertising
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
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 43 Tirohunga Drive, Henderson, Auckland Nigel Andrews Phone: (09) 836 2680 E-mail: njandrews@vodafone.co.nz Web: www.anza.co.nz	Advertising
Therapeutic Advertising pre-Vetting System (TAPS) Alternate Adjudicator 6 Kildare Avenue, Glendowie, Auckland Claire Hofer Phone: (09) 575 6573 E-mail: chofer@xtra.co.nz Web: www.anza.co.nz	Advertising
Therapeutic Advertising Pre-Vetting System (TAPS) Co. Association of New Zealand Advertisers Inc. P O Box 9348,Newmarket, AUCKLAND Jeremy Irwin Phone: (09) 300 5932 E-mail: anza@anza.co.nz Web: www.anza.co.nz	Advertising
Trident Clinical Research NZ Ltd. PO Box 305191, Triton Plaza, North Shore 0757, Auckland Michael Gibson Phone: +64 (0)9 478 0545 Fax: +64 (0)9 478 0560 E-mail: mgibson@tridentclinicalresearch.com Web: www.tridentclinicalresearch.com	Medical devices Clinical trials
Yasmeen & Associates 4 Chapel Court, Doncaster, Victoria 3108, Australia Dr Dilruba Yasmeen Phone: +61 3 9848 4770 E-mail: dyasmeen@bigpond.net.au	Applications for new/changed medicines Applications for new/changed related products

REGULATORY INFORMATION

Regulatory Consultants