Manufacturers, importers and distributors of medicines in the EU must be licensed before they can carry out those activities. The regulatory authorities of each Member State are responsible for granting licences for such activities taking place within their respective territories.read more
Welcome to the GMP Compliance Academy
Are you facing difficulties to find partners, marketing products, submit registration files & stringent GMP inspection due to complicated international regulations & guidelines?
GMP Compliance Academy (GCA) has been established with collaboration of Synergy Consulting, New Jersey, USA to offers a comprehensive consulting service on issues regarding GMP and Regulatory Compliance. Our partners have many years of experience in US FDA, EMEA, WHO& GCC regulations. As specialists and/or executives we bring in knowledge from all relevant areas of the industry with Global Experience of Asia, Africa, Europe & US.
Aseptic / Sterile Manufacture
GCA has vast experience to manufacturing Aseptic Products according to US FDA, EMA & WHO guidelines.
GCA has exclusive agreements with World Leading Biotech Centres for Biotech Products.
GCA expert team can help to optimize manufacturing operations for Solid/Liquid/Cream facility.
Production of APIs
GCA provides GMP Compliance Services to APIs Manufacturer as per ICH Q7.
GCA ensure client has effective and robust Quality Assurance that facilitates GMP Culture.
GCA provides services to ensure compliance of Good Laboratory Practices.
GCA provides formulation support for all dosage forms and training to prepare effective Pharmaceutical Development Report.
Calibration & Validation
GCA provides training and onsite execution of Calibration/Validation as per GMP requirements.