The Life Science Industry is the most regulated industry. APIs used in medicines to treat chronic diseases to the common cold would not be available to patients without the teams of specialists (including regulatory affairs professionals) who work to ensure that these APIs gain approval from the relevant Health Authorities, such as the MHRA and the US Food & Drug Administration (FDA).
Minakem provides regulatory support for the filing of its customers in order to fulfil with regulatory requirements. Minakem maintains all the documentation, needed by customers to submit New Drug Application file (NDA) or DMF registration for generic API’s.
- Regulatory strategy definition
- Writing DMF’s and CEP’s
- Life-cycle management of dossiers
- Regulatory and pharmacopoeia monitoring
- e-CTD submission
- Minakem has built a worldwide network with representatives in all key countries (USA, Japan, Korea, China…)
Minakem has a dedicated GMP lab for the generation of data required for the building of the regulatory files:
- Impurity studies
- Risk assessment
- Stability studies following the ICH guidelines
- Quality-by-Design (QbD)
- Development and validation of techniques to support analytical development
- Definition of RSM: evaluation of the quality of the potential source of raw material
More than 60% of the staff is a PhD
The first mission of this lab is to focus on Regulatory Affairs.
Planning of the lab is made according to authorities’ requests. Competences of the team are not only R&D/Analytical development but also compliance to regulation with continuous training on the latest guidelines.
Minakem’s manufacturing facilities are frequently audited by our Customers for Starting Materials, Key Intermediates and API’s. On average, 15 to 20 client quality audits are performed every year.
The general company policy is to provide the best product quality with all services and supporting documentation to all customers.