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.
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.
Whenever you need to file a registration to SwissMedic (Swiss Regulatory Authorities), keep track of every changes regarding Swiss regulations, develop 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 with a Pharmacist In Charge 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.
In his previous roles, Chris scope of responsibility did include the management of Corporate Affairs, Regulatory Affairs, Quality Assurance, Medical Affairs, Legal Affairs, Public Relations, Crisis Management while building close-knit relationship with government bodies and trade associations to achieve and maintain optimal market access for patients.
Chris leadership skills include the management of small to mid-sized teams and the development of broad and complex network across functions and geographies, with the ability to speak 4 languages and easily evolve in multi cultural environment.
With more than 10 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.