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

Want to work with us?