We offer tailored advice and support, focusing on EU GMP/GDP/GLP/GACP and GVP guidelines.
Our comprehensive services include:
- EU market accession
- Contract Responsible Person (RP), Qualified Person (QP) provision
- EU GMP/GDP/GACP Audits and Licensing
- Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), Good Agricultural and Collection Practice (GACP), Medical Cannabis compliance
- Quality Management Systems establishment and Standard Operating Procedures (SOPs) creation
- FMD Decommissioning of 2D Bar Codes
- Medical Devices compliance
- Pharmacovigilance services including Dossier Submission Review, EUQPPV and LCPPV Services, Post Marketing Life Cycle Management
- Laboratory Testing
- Contract Manufacturing
- Clinical Trials support
- Logistics Consultation
- Food Supplements and Cosmetics Registration
Our firm was established to provide top-notch regulatory assistance to clients involved in medicinal product manufacture and distribution, and other manufacturing processes necessitating a Quality Management System.
