Our expertise is defined by years of experience from corporate enterprises and independent companies. We combine our knowledge and experience to guide you through a preparation for an EU GMP audit and help you to get your product on the EU market, regardless the pharmaceutical form – sterile products, non-sterile products, solid dosage forms, oral solutions or eye drops.
Service covers all aspects of the pharmaceutical industry, including
manufacturing, development to successful registration of the product and life
cycle maintenance. We will implement our knowledge acquired from manufacturing
of active pharmaceutical ingredients by synthetic and fermentation route,
through sterile and non-sterile final dosage formulation, to regulatory affairs
and post approval monitoring of products to support you and your business.
Focus is mainly oriented on the markets of European Union; however, we also have experience with inspections and regulatory agencies of US FDA, Brazil Anvisa, Mexico Cofepris, Japan PMDA, South Korean FDA and others.
I am sure that with our Goal-Oriented Approach and implementation of Know-How Mapping we can satisfy your needs.
Already in the first quarter of this year, three European industry associations (EFPIA, Medicines for Europe and AESGP) published a “Call for a Mutual Recognition Agreement on Good Manufacturing Practice
After a four-year investigation by the U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) (and with the support of the London Regional Asset Recovery Team, RART), the owner of Guernsey-based
The European Commission, the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) have updated their questions and answers document on regulatory expectations for medicinal products for human use during the