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.
A video conference of the Ireland/Northern Ireland Specialised Committee was held early November exchanging updates on the implementation of the so called Northern Ireland Protocol. The meeting was co-chaired by officials
In view of recent experiences from inspections carried out for COVID-19 therapeutics, the World Health Organization (WHO) published a new working document entitled “GOOD MANUFACTURING PRACTICES FOR INVESTIGATIONAL PRODUCTS“. The