Minakem’s regulatory affairs department offers high-level expertise in managing registration dossiers for more than 15 years.
The team is specialized in the preparation and submission of regulatory dossiers such as Certificates of Suitability to the European Pharmacopoeia (CEP) and Drug Master Files (DMF), particularly for Europe, USA, Canada, Asia, and other international markets, as well as in supporting Marketing Authorization (MA) applications.
Our understanding of a complex regulatory landscape is strengthened by our involvement in industry associations and by our partnership with local regulatory agents in USA, Japan, South Korea, China, Brazil, …
Minakem successfully manage a portfolio of over 60 DMF / CEP, highlighting its extensive experience in this field.
Key Activities
The key activities of Minakem’s regulatory affairs team include
Preparing and submitting DMF / CEP dossiers to meet international regulatory standards.
Ensuring CMC compliance by thoroughly evaluating all required data and documentation, guaranteeing that each regulatory submission meets the highest standards for global market access.
Providing regulatory support throughout the project, from the early development stages to the dossier submission and approval
Compiling and submitting regulatory dossiers in CTD (Common Technical Document) format, ensuring alignment with market-specific requirements.
Managing the lifecycle of products, ensuring ongoing regulatory compliance from initial submission through post-approval activities: changes assessment, post-approval variation, …
Providing strategic input, expertise, advice and solutions to deal with regulatory hurdles in a complex and evolving regulatory environment.
Proactively international regulatory monitoring ensuring continuous regulatory compliance, maintaining the highest standards and anticipating regulatory evolutions to consistently deliver safe and effective products to the market.
Supporting customers in their Marketing Authorization registration during the different product development phases
• Investigational new drug applications (IND, IMPD, CTA)
• Marketing authorization applications (NDA, MAA, AMM)
• Generic drug applications (ANDA)
Minakem considers quality a priority and a major focus in terms of process, human resources and equipment.
Quality has always been and always will be a major focus of Minakem, both in terms of human resources and investing in new equipment.
Minakem operates under strict GMP conditions and commits to.
- Maintain the compliance of the quality system
- Make quality the responsibility of all employees and staff
- Ensure customer satisfaction
- Focus on continuous improvement
Minakem is fully compliant with international regulation, industry quality standards, manufacturing practices and safety and health and environment protection legislation.
- EHS Compliance & cGMP (ICHQ7A) Compliance
- Frequently inspected (authorities & customers)
- US cGMP certified
- European GMP 1 and 2 certified
Since the beginning of Minakem’s API production activities, our facilities have a long and successful track record of inspection by health authorities and client audits.
Our general policy is to provide our clients with full supporting documentation for their business to be a success. Our Quality Assurance system is built in order to validate that Minakem will reach its goal as an organization fully dedicated to complete client satisfaction.
They trust us
Our Certification
Minakem considers quality a priority and a major focus in terms of process, human resources and equipment.
Knowing, understanding and monitoring the regulatory landscape leads to accelerate time-to-market and ensure compliance
Our quality system
Designed to ensure that products are effective, safe and comply with end-user and regulatory requirements.
It includes rigorous production management, compliance with GMP standards, raw materials control, process validation, risk and non-conformity management, as well as regular audits and exhaustive documentation.
