The CEP (Certificate of Suitability to the Monographs of the European Pharmacopoeia) is a certificate issued by the EDQM (European Directorate for the Quality of Medicines & HealthCare).
It certifies that an active pharmaceutical ingredient (API) or an excipient complies with the requirements of the relevant European Pharmacopoeia monograph, including, where applicable, compliance with TSE/BSE (Transmissible Spongiform Encephalopathy/Bovine Spongiform Encephalopathy) risk management requirements.
A CEP confirms that the quality of the substance can be adequately controlled through the corresponding Pharmacopoeial monograph, supplemented by additional tests where necessary.
A DMF (Drug Master File), referred to in Europe as an ASMF (Active Substance Master File), is a confidential regulatory dossier submitted to health authorities.
It provides detailed information regarding :
The purpose of the DMF/ASMF is to demonstrate the quality, safety, and purity of the active pharmaceutical ingredient in accordance with regulatory requirements established by authorities such as the EMA and the FDA.
Compliance with Good Distribution Practices (GDP) is essential for pharmaceutical laboratories and logistics operators.
GDP standards ensure the quality, integrity, and traceability of medicines throughout the entire supply chain, from manufacturing to final delivery.
Good Manufacturing Practices (GMP) consist of a set of regulatory requirements designed to ensure the consistency and reproducibility of manufacturing operations.
These standards establish a robust quality management system that guarantees :
“A Strategic Investment for Commercial and Scientific Performance”
In an increasingly competitive, regulated, and demanding pharmaceutical environment, medical representatives can no longer be limited to simply presenting products. They must become true scientific partners to healthcare professionals, capable of providing reliable, relevant, and tailored information that meets prescribers’ needs.
Continuous training of the sales force is therefore a key driver for:
FRILAB prioritizes partnerships with manufacturers whose raw materials are supported by a DMF or a CEP and seeks to work primarily with production facilities operating in compliance with European GMP standards.
This approach ensures the highest levels of pharmaceutical quality and regulatory compliance.
All manufactured medicines are stored and distributed through three strategic pharmaceutical logistics partners located in France.
Each of these facilities is fully GDP-certified and holds the necessary pharmaceutical authorizations.
Key distribution practices include :
These measures ensure product integrity, traceability, and supply chain efficiency.
FRILAB guarantees the worldwide shipment of pharmaceutical products by sea and air in full compliance with international regulations.
This includes the use of :
As a result, FRILAB is able to comply with the full range of Incoterms requested by its customers while maintaining product quality throughout transportation.
In every country where FRILAB products are marketed, we actively monitor supply levels to ensure continuous product availability.
Our commitment includes :
Our objective is simple : to ensure uninterrupted patient access to essential healthcare solutions.
Certificates are issued by Swissmedic and can be consulted through the SwissGMDP database.
FRILAB Pharmaceutical Authorization & GDP Certificate: https://www.swissgmdp.ch/establishments/sites/MP_1002438