Pharmaconsulta Limited is an independent consultancy firm based in Malta (EU) specialising in Pharmaceutical Regulatory Affairs. Besides offering consultancy services, we also offer Contract Manufacture, Laboratory Analysis and QP Batch Release through our affiliated companies that are all GMP audited and certified.
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.
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) positions and Qualified Person Pharmacovigilance (QPPV). Our clients include international pharmaceutical companies based inside and outside the EU (3rd Country) and 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 penetration
- Local Representation and Distribution
- Contract Responsible/Qualified Person (RP)/(QP) provision
- EU GMP & EU GDP
- EU GACP and PV Audits
- Pre-inspection preparation and Post Inspection Licence maintenance
- Regulatory Intelligence for Pharmacovigilance
- Dossier Submission Review
- Medical Device and Medicinal Product Life Cycle Management
- Food Supplements and Cosmetics Registration
- Patient Information Leaflet (PIL)
- Summary of Product Characteristics (SPC) and Direct Health Professionals
- Communication (DPHC) origination and printing
- Advertising Review
- Quality Management System creation and maintenance including Standard Operating
- Procedures creation (SOP)
- Warehousing and Logistics
- Regulatory Solutions and Strategic Planning
- EU GACP certification
- Centralised Procedure registration of medicinal products.
”We pride ourselves on providing the best service globally. We are a team of highly skilled and motivated individuals who are committed to supporting concerned entities within the pharmaceutical industry by providing cost-effective, efficient and holistic regulatory solutions.
Pharmaconsulta Mission Statement
Meet The Team
We are a team of highly skilled and motivated individuals who are committed to supporting concerned entities within the pharmaceutical industry by providing cost effective, efficient and holistic regulatory solutions. We pride ourselves in providing the best service in an ever-evolving global market.