Need a Qualified Person?
We provide services as Qualified Person. With many years of experience within QA, QC and Production the legal basis for the Qualified Person as defined in directive 2001/83/EC and 2001/20/EC of The European Parlament is fulfilled.
Function as QP is provided within the area´s of
– Manufacturing of commercial products within:
– Classic tablet manufacturing
– Sterile formulations
– Herbal medicine
– Manufacture and release of Clinical Trial Material (Phase I-II-III)
– Parallel Import (including veterinary medicinal products)
– Import and release of drug products from third countries
Need an experienced Auditor?
Pharmac has many years of auditing experience within the area of e.g. Pharmaceutical Manufacturing including sterile – non-sterile and biologics, API-manufacturing, Drug Development, GDP, Devices and Packaging materials.
Need an experienced GMP/GDP ressource?
We have several years of experience as GMP/GDP specialists in different companies and disciplines such as Quality Assurance, Quality Control and Manufacturing of Drug Substances, Drug Products and Cosmetics.
Our goal is to assure that your quality management system matches the needs related to your activities. No more and no less.