Our company is composed of specialised pharmacists and medical doctors who have extensive work experience at EU GMP and GDP approved sites as well as many years in regulatory positions such as Responsible Person (RP) and Qualified Person Pharmacovigilance (QPPV) positions. Our clients include international pharmaceutical companies based both inside and outside of the EU, 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
Good Manufacturing Practice (GMP) – Good Distribution Practice (GDP) – Good Agricultural and Collection Practice (GACP) – Medical Cannabis – Quality Management Systems – Standard Operating Procedures (SOPs) creation
Dossier Submission Review – EUQPPV and LCPPV Services – Post Marketing Life Cycle Management – Medical Cannabis – Quality Management Systems – Standard Operating Procedures (SOPs) creation
The firm was set up to provide high quality regulatory assistance to clients involved in manufacture and distribution of medicinal products and other manufacturing processes that require a Quality Management System to be in place.