Regulatory affairs of drugs, medical devices and cosmetics
Baggerman Farma Consult has been involved in the regulatory procedures for a wide variety of drugs and medical devices and is fully acquainted with the EU Directives involved. The company is responsible for the regulatory matters, including product license maintenance, of a significant number of European companies in the Netherlands and is also regularly involved in European centralized procedures, mutual recognition procedures or decentralized procedures. Similarly it has been involved in the CE marking procedures for various types of medical devices as well as safety evaluations of cosmetics.Baggerman Farma Consult is also familiar with all the documentation required for the regulatory processes, including nonclinical, clinical and pharmaceutical overviews and technical files. Other areas of the company’s expertise are clinical trial applications and reimbursement procedures for pharmaceuticals as well as vigilance programs for drugs or medical devices.
