There is a need of a clear articulation of medical science and well-structured documents that present information clearly and concisely.
A dedicated team fully experienced on clinical and literature research develops scientific documents for support of, for eg., Marketing Authorizations (MA) applications, MA renewals, MA variations, reimbursement applications for a vast type of medicinal products and health products, for different legal basis applications:
• Non-Clinical Overview (Module 2.4.);
• Clinical Overview (Module 2.5.);
• Clinical Summary (Module 2.6);
• Non-Clinical Summary (Module 2.7);
• Module 4;
• Module 5;
• Pharmacotherapeutic Reports;
• Prescription to OTC Switch Clinical and Safety Reports;
• Environment Risk Assessment (ERA);
• Other scientific documentation on request.