Services

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 supports or advices on the regulatory processes including: Marketing Authorization Applications (MAA) Product Dossier Maintenance (preparation, submission, follow-up) Regulatory procedures

Baggerman Farma Consult has wide experience in the design and implementation of Quality Systems. These include Quality systems such as: Pharmaceutical production facilities (GMP/GCP) Distribution facilities, warehousing (GDP) Medical Device companies (ISO) OTC/Food companies (HACCP) Qualified Person services Audit services

Pharmacovigilance has grown more and more important in the last few years. Baggerman Farma Consult can provide expert safety consulting in the fields of Pharmacovigilance such as: Qualified Person for the Pharmacovigilance services (QPP) Drug Safety Officer services (DSO) Signal detection, case processing optimization Preparation of Period Safety Update Reports

In recent years BFC developed a EU-Market Access Program to support pharmaceutical companies with the marketing of pharmaceutical products. It includes all necessary elements for the launch of a pharmaceutical product on the Dutch or European market. These elements can consist of: Marketing authorization approval process Supply chain support and distribution strategy