carsl.co.nz

CARSL Consulting

We Cover all Facets of the Regulatory Process for the various Industry Sectors. Broad range of Experience. Brian Day formed CARSL Consulting in 1996 to provide regulatory services to the pharmaceutical industry. Brian has worked within the industry for 38 years and along with his associates, offers a specialised knowledge, incorporating a broad range of experience. Our experience and knowledge ensure our clients always receive accurate and cost effective regulatory advice. Medicines Amendment Bill 2011.

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CARSL Consulting | carsl.co.nz Reviews

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We Cover all Facets of the Regulatory Process for the various Industry Sectors. Broad range of Experience. Brian Day formed CARSL Consulting in 1996 to provide regulatory services to the pharmaceutical industry. Brian has worked within the industry for 38 years and along with his associates, offers a specialised knowledge, incorporating a broad range of experience. Our experience and knowledge ensure our clients always receive accurate and cost effective regulatory advice. Medicines Amendment Bill 2011.

<META> KEYWORDS

1 services

2 about us

3 links

4 latest news

5 prescription/non prescription medicines

6 complementary medicines

7 medical devices

8 in vitro diagnostics

9 quality management

10 pfizer chemicals

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CARSL Consulting | carsl.co.nz Reviews

https://carsl.co.nz

We Cover all Facets of the Regulatory Process for the various Industry Sectors. Broad range of Experience. Brian Day formed CARSL Consulting in 1996 to provide regulatory services to the pharmaceutical industry. Brian has worked within the industry for 38 years and along with his associates, offers a specialised knowledge, incorporating a broad range of experience. Our experience and knowledge ensure our clients always receive accurate and cost effective regulatory advice. Medicines Amendment Bill 2011.

INTERNAL PAGES

carsl.co.nz

1

Medical Devices

http://www.carsl.co.nz/Services/Medical+Devices.html

Currently medical devices are required to be listed in Medsafes WAND database within 30 days of being supplied in New Zealand or exported. The regulatory controls on medical devices are expected to increase significantly on commencement of the Australia New Zealand Therapeutic Products Authority (ANZTPA). We can provide:. WAND and DEAL notifications. Advice on best approach to transitioning devices to any new regulatory scheme. ISO 13485 preparation and implementation. Conformity Assessment and CE marking.

2

Quality Management

http://www.carsl.co.nz/Services/Quality+Management.html

We have a team of experienced professionals who can assist with:. Quality system management including audits and SOP preparation. Assistance with obtaining wholesalers and other licences. Quality Assurance including compliance checking of imported product. Product recalls and quality complaints .

3

Complementary Medicines

http://www.carsl.co.nz/Services/Complementary+Medicines.html

Currently dietary supplements are controlled by the Dietary Supplements Regulations 1985. We provide advice concerning compliance with these regulations in terms of labelling, permitted ingredients and acceptable claims. The proposed Natural Health and Supplementary Products Act is expected to become effective in late 2014, see Latest News. We also provide advice and assistance on the listing of complementary medicines in Australia.

4

Links

http://www.carsl.co.nz/Links.html

Advertising Standards Authority of New Zealand. Centre for Adverse Reactions Monitoring (CARM). Environment Protection Authority (EPA). Food Standards Australia and New Zealand. Health and Disability Commissio. Health Research Council of New Zealand. Medical Technology Association of New Zealand. New Zealand Food Safety Authority (NZFA). New Zealand Guidelines Group. New Zealand Health Information Service. New Zealand Legislation - Acts (statutes) and Regulatory (statutory regulations.

5

In-Vitro Diagnostics

http://www.carsl.co.nz/Services/In-Vitro+Diagnostics.html

Under the proposed Australia New Zealand Therapeutic Products Authority (ANZTPA) in-vitro diagnostics would be controlled in a similar fashion to medical devices. We can provide advice on the regulatory controls as they become apparent to ensure compliance for your in-vitro diagnostics.

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About Us

https://secure.zeald.com/carsl/About%20Us?mv_pc=1036

Brian Day, NZCS - Director. Brian has over 38 years experience in the pharmaceutical industry including. Medical and regulatory affairs. Alan Stanley, M.Sc -. Technical, Regulatory, Quality, Development and Operational Consultant to the Medical Device Industry. Quality Manuals, GMP, Standard Operating Procedures and Internal Audits. Programmes for CE marking, Conformity Asessment and ISO 13485. Facility, Sterilization and Clean Room operations. Recalls and Field Corrective Notifications. Quality systems ...

secure.zeald.com

About Us

https://secure.zeald.com/carsl/About%20Us?mv_pc=1037

Brian Day, NZCS - Director. Brian has over 38 years experience in the pharmaceutical industry including. Medical and regulatory affairs. Alan Stanley, M.Sc -. Technical, Regulatory, Quality, Development and Operational Consultant to the Medical Device Industry. Quality Manuals, GMP, Standard Operating Procedures and Internal Audits. Programmes for CE marking, Conformity Asessment and ISO 13485. Facility, Sterilization and Clean Room operations. Recalls and Field Corrective Notifications. Quality systems ...

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