Documentation Regulation

MINAKEM offers our customers extensive experience in regulatory operations and a wide range of writing services for regulatory submissions. Our staff displays extensive knowledge of the regulatory affairs and quality assurance rules to produce validation protocols, study reports, safety reports, stability studies and reports, drug master files (DMF) and Certificates of conformity for European Pharmacopeia (CEP) in compliance with the ICH guidelines, plus safety reports, and support to customers for INDs, BLAs and NDAs.

We have experience with a range of global regulatory submissions in countries worldwide, including changes to the regulatory requirements of European Union countries now under the EU directive, and can provide clear guidance on these changes to our customers.

This covers as well new products subject to ELINCS registration (formerly ENEICS) and now the new REACH regulation. The registration process requires the manufacturers and importers to generate data for all chemicals substances produced or imported into the EU above one tonne per year. The registrants such as MINAKEM must also identify appropriate risk management measures and communicate them to the users.

MINAKEM supports on demand the market authorizations and drug applications of its customers with relevant regulatory documents. MINAKEM holds for all active pharmaceutical ingredients Drug Master Files (DMF´s) and /or Certificates of Conformity with the European Pharmacopeia (CEP´s).

These documents are prepared during product development, submitted to the authorities, and maintained during the life cycle of the products.