Contact Us
QP-Services UK Ltd
46 High Street
Yatton
Bristol
Somerset
BS49 4HJ
United Kingdom
Tel: +44 (0) 1934 838820
Established for 20 years, we are an independent company specialising in quality, safety (vigilance) and regulatory services.
Our key activities include: eCTD preparation (fragment & complete), QPPV, QP, RP, regulatory, submissions, manufacturing GMP compliance, MIA importation and QP certification.
One Stop Shop – The only consultancy you need.
Full technical service or pick only the services appropriate to your business
Our Services
Regulatory Affairs
- Human and Veterinary Medicinal Products
- New Applications
- Variations Type I, Type II
- Marketing Authorisations
- WDA, MIA, ManA, MS Submissions
- Packaging (inc. artwork mock-ups)
- Renewals, transfer of ownership, sunset clause
- Mutual Recognition Procedure (MRP) & Decentralised Procedure (DCP) Applications
- Regulatory strategy and support
eCTD & NeeS
- Common Technical Documents (CTD)
- Non-eCTD electronic Submissions (NeeS and VNeeS)
- Human and Veterinary Medicinal Products
- EU, UK, Rest of World
- Preparation of full dossiers for new product applications
- Converting NeeS or paper dossiers into eCTD
- Origination, compiling, publishing & validation
GMP and GDP Compliance
- Responsible Person for GDP
- Post-Brexit RPI Responsible Person for Importation
- Two “Gold Standard” Qualified RPs Available
- GDP and GMP Compliance Gap Analysis
- Inspection Preparation
- Practical Ongoing Compliance Solutions
- Falsified Medicines Directive (FMD) Compliance
- Medicinal Product Supply Chain and Transportation Expertise
- Cosmetic GMP
- Atypical API Management
- Excipient GMP
- Stability and Compatibility Testing Protocols and Study Management
- Analytical Method Development, Validation and Lab-to-Lab Transfer with MHRA GMP Contract Laboratory
Pharmacovigilance (Safety)
- Qualified Person for Pharmacovigilance (QPPV)
- Weekly Literature Searches
- Periodic Safety Update Reports (PSURs)
- Risk Management Plans (RMPs)
- Ongoing Signal Detection & Evaluation
- ADR Electronic Reporting (EVWEB)
- ADR Investigation & Medical Information
- Inspection Preparation & Handling
MIA / Qualified Person Release
- MIA 29498 Importation and QP Certification / Batch Release of Human Medicinal Products from Outside EEA
- ManA 29498 Importation and QP Certification / Batch Release of Veterinary Medicinal Products from Outside EEA
- Analytical Release Testing in Conjunction with MHRA GMP Contract Laboratory
Medical Device and Cosmetics
- Quality Management Representative for Medical Devices
- Responsible Person for Cosmetic Compliance
- Cosmetic Product Information Files (PIF)
- Medical Device Technical Files (TF)
- Vigilance/Cosmetovigilance
- Labelling Compliance
Manufacturing Support
- Annual Product Reviews
- Batch Reviewing
- Change of Manufacturer
- Validation
- Good Manufacturing Practice (GMP) Compliance
- Auditing – Finished Product
- Auditing – API
- Experienced in Most Product Forms
Project Work
- Training – GDP / GMP / Pharmacovigilance
- Stability Protocols and Monitoring
- Analytical Methods – Lab-to-Lab Transfer, Validations
- Gap Analysis – Regulatory, PV, GMP, GDP
- Quality Systems – GMP, GDP
Quality Management Systems
- Cloud or Paper Based Solutions
- Standard Operating Procedures
- GMP, GDP, Cosmetic, Medical Device ISO13485
- CAPA, Audits, Change Control
- Regular Quality Review Meetings
- Key Performance Indicators
- Tried and Tested Processes Adapted to Your Work Environment