Our company is composed of specialised pharmacists and medical doctors with vast work experience in EU GMP and GDP approved sites as well as numerous years of regulatory positions such as Responsible Person (RP) and Qualified Person Pharmacovigilance (QPPV) positions. Our clients include international pharmaceutical companies based inside and outside the EU (3rd Country) as well as local distributors that require regulatory and licensing support.
We provide specialist advice and assistance with particular emphasis on EU GMP/GDP/GLP/GACP and GVP guidelines. The services we offer include but are not limited to:
- ► EU market accession
- ► Contract Responsible Person (RP), Qualified Person (QP) provision
- ► EU GMP/GDP/GACP Audits and Licensing
- ►FMD Decommissioning of 2D Bar Codes
- ►Medical Devices
- ►Laboratory Testing
- ►Contract Manufacturing
- ►Clinical Trials
- ►Logisticts Consultation
- ►Food Supplements and Cosmetics Registration
The firm was set up to provide high quality regulatory assistance to clients involved in manufacture and distribution of medicinal products and other manufacturing requiring a Quality Management System in place.