Medical Writing

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.