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Pharmaceutical Affairs Consulting

ABOUT US

Pharmadossiers was founded 30 years ago in 1987 by Chantal Doelker and Marie-Hélène Rutz-Coudray, two passionate pharmacists, eager to support the pharmaceutical industry in filing regulatory application to gain market authorisation in the shortest time possible.

Whenever you need to file a registration to SwissMedic (Swiss Regulatory Authorities), keep track of every changes regarding Swiss regulationsdevelop a state-of-the art Quality Control process, or receive strategic / technical advice before or after you market 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 authorisation
Swiss & Foreign Trade License

Preparation of state-of-the-art promotional and educational documents

Quality Assurance & Control

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 quality team

Hold GxP authorizations for companies still not implemented in Switzerland

Market Access

Evaluation and preparation of the documentation for 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.

OUR TEAM

With inside out knowledge of pharmaceutical industry needs, our team will help you to develop and implement the best strategy, while providing you with the tools and skillsets needed to achieve a successful launch of your products.

Biologist by training, Laetitia joined Pharmadossiers in 2007 as Regulatory Affairs Manager, where she was in charge to develop and implement regulatory strategies to obtain market authorisations for human products and Biosimilars with a quick turnaround.

With more than 15 years of experience in the field of regulatory affairs, Laetitia knows Swissmedic inside out and is able to be ahead of the game, when critical decisions have to be taken.