Services

Regulatory Affairs

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

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Quality Affairs

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

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Pharmacovigilance

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

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Market Access Program

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

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