Regulatory Expertise
Regulatory Expertise
We audit against the regulatory frameworks we understand in depth, not checklists derived from regulatory text. Our expertise spans EU GMP, GDP, GCP, GLP, GVP, FDA regulations, ISO standards and medical device regulations.
Good Manufacturing Practice (GMP)
EU GMP is the primary framework governing the manufacture of medicinal products for human use in Europe. EU GMP Volume 4 (Parts I, II and III) establishes detailed requirements covering quality management, personnel, premises and equipment, documentation, production, quality control, outsourced activities, complaints and recalls, and self-inspection. ICH Q10 provides the international pharmaceutical quality system model that underpins GMP compliance globally.
Key Standards & Regulations
- EU GMP Part I (Finished Products)
- EU GMP Part II (APIs)
- EU GMP Part III (GMP Related Documents)
- FDA 21 CFR 210/211
- ICH Q7, Q8, Q9, Q10, Q11
- WHO Technical Reports on GMP
- PIC/S GMP Guide
Good Distribution Practice (GDP)
GDP governs the storage, transport and distribution of medicinal products within the supply chain. EU GDP Guidelines 2013/C 343/01 establish requirements for wholesale dealers including quality management, personnel, premises and equipment, documentation, operations, complaints and returns, outsourced activities, and self-inspections. The Responsible Person has specific legal obligations under the GDP regulatory framework.
Key Standards & Regulations
- EU GDP Guidelines 2013/C 343/01
- MHRA GDP Guidance
- EU Directive 2001/83/EC (Chapter VII)
- FMD Delegated Regulation 2016/161
- WHO Model Guidance for Storage and Transport
Good Clinical Practice (GCP)
GCP is the international ethical and scientific quality standard for designing, conducting, recording and reporting clinical trials involving human subjects. ICH E6(R2) provides the primary GCP guideline, supplemented by EU Clinical Trials Regulation 536/2014, EMA GCP guidelines and national requirements. GCP protects trial subject rights and ensures clinical data credibility for regulatory submission.
Key Standards & Regulations
- ICH E6(R2) Good Clinical Practice
- EU Clinical Trials Regulation 536/2014
- FDA 21 CFR Parts 50, 54, 56, 312
- EMA GCP Guidelines
- MHRA GCP Guidance
- ICH E8(R1) Study Design
Good Laboratory Practice (GLP)
GLP establishes the organisational processes and conditions under which non-clinical safety studies are planned, performed, monitored, recorded, archived and reported. OECD GLP Principles (1997, revised 2018) provide the international framework, transposed into EU Directive 2004/10/EC and national regulations. GLP compliance is a prerequisite for regulatory acceptance of non-clinical safety data.
Key Standards & Regulations
- OECD GLP Principles
- 21 CFR Part 58 (FDA)
- EU Directive 2004/10/EC
- MHRA GLP Monitoring Authority
- OECD Series on Principles of GLP
Good Pharmacovigilance Practice (GVP)
GVP Modules (I through XVI) establish requirements for all pharmacovigilance activities of marketing authorisation holders operating in the EU. The QPPV system, PSMF maintenance, ICSR reporting, PSUR production, signal detection and risk minimisation activities are all governed by specific GVP Module requirements. EU PV legislation was substantially reformed in 2012 under EU Directive 2010/84/EU.
Key Standards & Regulations
- EMA GVP Modules I–XVI
- EU Directive 2010/84/EU
- EU Regulation 1235/2010
- UK Human Medicines Regulations
- FDA 21 CFR Part 314 (Pharmacovigilance)
FDA Regulations
FDA regulations governing pharmaceutical and biological medicine manufacturing are codified in Title 21 of the Code of Federal Regulations. Key regulations include 21 CFR 210/211 (CGMP for Finished Pharmaceuticals), 21 CFR 600-680 (Biologics), 21 CFR Part 11 (Electronic Records/Signatures) and 21 CFR 820 (Quality System Regulation for Devices). FDA enforcement through warning letters, import alerts and consent decrees requires detailed regulatory knowledge.
Key Standards & Regulations
- FDA 21 CFR 210/211 (CGMP)
- 21 CFR Part 11 (Electronic Records)
- FDA 21 CFR 820 (Device QSR)
- FDA Process Validation Guidance (2011)
- FDA Data Integrity Guidance (2018)
- FDA Warning Letter Precedents
ISO Standards
ISO standards provide internationally recognised quality and management system frameworks applicable across pharmaceutical, medical device and manufacturing sectors. ISO 13485 is the QMS standard for medical devices. ISO 9001 provides the foundation quality management system. ISO 14971 governs medical device risk management. ISO 17025 establishes laboratory competence requirements.
Key Standards & Regulations
- ISO 13485:2016 (Medical Devices QMS)
- ISO 9001:2015 (Quality Management)
- ISO 14971:2019 (Risk Management)
- ISO 17025:2017 (Laboratory Competence)
- ISO 27001 (Information Security)
- ISO 45001 (Occupational Health)
Medical Device Regulations
EU MDR 2017/745 and IVDR 2017/746 established a comprehensive new regulatory framework for medical devices and in vitro diagnostics in Europe. Requirements for technical documentation, clinical evaluation, post-market surveillance, UDI and Notified Body certification are substantially more demanding than the predecessor MDD/IVDD. FDA 21 CFR 820 and the MDSAP programme govern device quality systems in the US and other major markets.
Key Standards & Regulations
- EU MDR 2017/745
- EU IVDR 2017/746
- FDA 21 CFR Part 820 (QSR)
- ISO 13485:2016
- MDSAP Programme
- MEDDEV Guidelines
Speak with a Regulatory Specialist
Contact our team to discuss your specific regulatory framework and how our expertise can support your compliance programme.