Expertise

Pharmassent’s advanced technical and analytical expertise, regulatory review, and advanced facilities can help you obtain faster regulatory approval. Our expertise in regulatory compliance and project facilitation with ANSM and EMA practice can bring your brand and product improved recognition. You can rely on our expertise to get your products (drugs and/or medical devices) to the French market faster. We provide tailored solutions for the most important stage of your product’s life cycle. We start with regulatory affairs consultancy, then help elaborate product management plans, to bring your product to the market. With our experience, we can help you achieve greater sales success in the European pharmaceutical industry.

Pharmassent is experienced in evaluating French and European product admission requirements, definition of development and registration strategies according to French and EU regulations, due diligence and drug candidate evaluation. Pharmassent can review and help you to prepare documents (CTD) for pharmaceutical approval procedures. We provide an assessment report identifying complementary studies to ensure registration in France or other EU countries. Pharmassent offers regulatory consulting and guidance for regulatory submission and market registration.

Pharmassent helps you submit documents to ANSM, we provide support for follow-up of procedures and contact with health authorities, and we prepare your staff for meeting with ANSM officers for final approval (AMM) and ensure that you receive the best advice for getting your product to market. We help your company to pre-launch global drug pricing and reimbursement registration procedures. With our knowledge and European expertise, we can provide customized product registration solutions, including engagement with the specific related authorities and post-registration license management.