Quality Management

In the regulated industry, special care must be taken to ensure all equipment and processes are performing to specifications. Deviations from the norm could have unpredictable and sometimes devastating results. Therefore, Medichem pays special attention to equipment qualification and process validation to provide full regulatory compliance to our clients. We follow the strictest guidelines, perform the most rigorous testing and execute studies in a timely fashion to ensure your product is of the highest quality when it reaches its destination.

Medichem has capabilities to develop, create and execute validation protocols and studies required for your products and equipment that are required for your projects in accordance with current guidelines (FDA, EP, ICH…).

Quality Assurance

Medichem has a thorough commitment to quality and compliance. The top quality of Medichem’s services and products is based on a perfected quality management system. Most importantly, it is the outcome of a grown cGMP culture in which all Medichem associates live and work day in and day out.
Medichem manufactures APIs and intermediates in accordance with ICH Q7A guideline on Good Manufacturing Practice Guide for APIs.

  • Medichem has a long and successful history of inspections by clients and regulatory authorities, including the FDA whose last four consecutive inspections in 1999, 2002, 2006 and 2009 resulted in “No Form 483” being issued.
  • Our quality system management and up-to-date manufacturing techniques guarantee the consistent high quality of production through strict cGMP compliance, being ISO 9001 certified since 1996.
  • As Medichem applies cGMP concepts and guidance to every manufacture step, both on the production sites and in its research centres, our personnel is continuously trained on the highest standards of cGMP and therefore ensures constant cGMP compliance.
  • Medichem respects the environment as it has its own waste water treatment plant, being ISO 14001 certified.

Quality Control

Medichem provide analytical services at all stages of the drug development process: from the initial release of raw materials to chromatography method development (or implementation of existing methodology from clients) via in-process testing to the final release of product by the Certificate of Analysis (CoA).
Analyses are carried out in a cGMP/GLP compliant laboratory setting. Our analytical services department has a high level of expertise in method development, optimisation and validation. It has established a variety of analytical techniques.

  • A group of almost 30 people, highly trained with extensive experience in the development and validation of analytical methods including complex separation problems, underpin chemical research throughout all product development stages.
  • Our QC laboratories are fully equipped with state of the art analytical instrumentation, such as HPLC, GC, FT-IR, UV, heavy metals, loss on drying, Karl Fischer and much more.
  • We develop and perform methods of analysis for particle size by laser diffraction
  • Chemical and stability testing are carried out according to ICH standards.

Regulatory Affairs

We provide regulatory guidance due to our broad experience in drug substance development as well as commercial scale production. We support our customers with the registration and implementation of drug regulations and guidelines issues by International regulatory authorities. Our Regulatory Affairs team supports the Process Development, Scale-up and Manufacture of your project, making time to market as swift and smooth as possible.

  • Medichem runs a highly dedicated and skilled regulatory affairs department that has filed more than 300 Drug Master Files (DMF) and 7 Certificates of Suitability (CEP) of the monographs of the European Pharmacopoeia.
  • Our regulatory department constantly interfaces with decision-making bodies in the API field such as health authorities and industry association groups in the European Union and United States.
  • Beyond the preparation of regulatory documentation, Medichem is ready to support the customer from Investigational New Drug (IND), though New Drug Application (NDA) to market supply.

Legal Affairs and IP

Our policy is to design manufacturing processes that do not interfere with any intellectual property. Medichem provide legal and patent support with experience, industry knowledge and resources to ensure the client get complete and accurate information, each and every time.

  • Our experienced patent department is capable to support you throughout the entire drug development process or can assist you with its expertise in a special area.
  • Medichem’s confidentiality agreements do strongly respect the intellectual property and thus protect your interests.
  • Our strength is our people. Our legal and patent experts at Medichem bring hold advanced degrees in various disciplines. Our searchers utilise the best data sources, making sure no stone is left unturned, and work quickly and efficiently to complete each project at hand.
Quality Management