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Pharmaceutical Affairs Consultants

Pharmadossiers was founded 30 years ago in 1987 by Chantal Doelker and Marie-Hélène Rutz-Coudray, two pationated pharmacists, eager to support the pharmaceutical industry in filing regulatory application to gain the market authorisation in the shortest time possible. Today under the partnership of Laetitia Cuccuru and Christophe-G. Christophi the takeover is guaranteed with these seasoned professionals with more than 25+ years experience in the pharmaceutical industry.

ABOUT US

Whenever you need to file a registration to SwissMedic (Swiss Regulatory Authorities), keep track on every change regarding the Swiss regulations, develop a state-of-the art Quality Control process or to receive strategic or technical advice before or after you market your products in Switzerland and abroad, we will timely support and assist you with passion.

Regulatory Affairs

Registration of pharmaceutical human and veterinary products and medical devices to SwissMédic
Registration of dietetic and cosmetic products to the Swiss Social Health Insurance (OFSP)

Evaluation and preparation of registration documents for new chemical entities (NCE) or generics
File submission to relevant authorities for market authorization
Export registration

Preparation of state-of-the-art advertising documents

Quality Control & Insurance

Development of all the needed documentation to successfully gain a GxP status according Swiss regulations: Site Master File (SMF), Standard Operating Procedures (SOPs)

Preparation of inspection and coaching of the employees

Hold GxP authorizations with a Pharmacist In Charge for companies still not implemented in Switzerland

Market Access

Evaluation and preparation of the needed documentation fo reimbursement and access

File for product acceptance and reimbursement by the Swiss Social Health Insurance (OFSP)
Support directly the price negotiation with the relevant authorities including Health Insurers.

RECENT WORKS

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OUR SERVICES

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Basic

For beginners
CHF$$$/month
Get Started

Premium

For professionnal
CHF$$$/month
Get Started

RECENT POSTS

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