GMP application and product dossier application
| 18/04/2023 558
Consulting construction and development new products
Provide registration, validation and production guidance services, analysis and product stability studies to ensure EU GMP certification for pharmaceutical factories.
• Provide registration service according to national process or decentralized process
• Guide to deploying trial production, determining batch size
• Guidelines for the evaluation of production processes, hygiene appraisals
• Guidelines for appraisal of analytical methods, validation of analytical methods
• Guidelines for conducting stability and bioequivalence studies
• Instructions to complete the application for MA
• Manage and monitor the application process until receiving the MA
With professional knowledge and experience in the field of pharmaceutical manufacturing, the expert team of GMPc and Inotek Pharma will offer solutions to develop new products, optimize production efficiency and improve product quality. for customer's factory.
EU GMP assessment service
Comprehensive EU GMP assessment consulting services, including conducting a deficiency assessment, preparing the required documentation, supporting CAPA implementation and coordinating with the legal representative.
• Carry out a flawed assessment of factory documentation in line with EU GMP requirements
• Training in preparation for appraisal by the Drug Administration, performing mock inspection
• Provide legal representation in one of the selected ries in the European community
• Prepare a set of documents at the request of the European Medicines Agency
• Submit an invitation to the Drug Administration through a legal representative in Europe
• Monitor and coordinate the EU GMP due diligence process
• Support for CAPA implementation after appraisal
• Coordinate with the legal representative after completing the assessment until the GMP certificate is received
GMPc Vietnam and Inotek Pharma are committed to providing customers with high quality, professional EU GMP assessment consulting services, ensuring full compliance with regulations and requirements of the European Medicines regulatory agency, helping Factory gain EU GMP certificate quickly.