Global Regulatory Services
Consultancy based in Cambridge, UK providing regulatory and quality compliance services for life sciences. Supports clients across pharmaceuticals, biologics, biosimilars, medical devices and IVDs, cosmetics, herbals, nutraceuticals and nanotechnology through a global network of local regulatory and scientific professionals. Holds European SME status.
Industries
Nr. of Employees
small (1-50)
Global Regulatory Services
Sutton, England, United Kingdom
Products
UK Responsible Person (UKRP) Services
Comprehensive UK Responsible Person (UKRP) services ensuring seamless market access and compliance for manufacturers in the life sciences industry including medical devices, pharmaceuticals, cosmetics, and advanced therapeutics.
Electronic Common Technical Document
Professional eCTD publishing and regulatory submission support services ranging from Clinical Trial Applications to full Marketing Authorisations.
Regulatory Affairs and Compliance Services
Comprehensive regulatory affairs, compliance, and lifecycle support services for the international life science, pharmaceutical, and healthcare industry.
Orphan Drug Status Services
Regulatory consulting services to help companies apply for orphan drug designation with the EMA and US FDA, enabling access to incentives, fee reductions, and marketing exclusivity.
Pharmaceuticals Regulatory Compliance Services
Regulatory compliance, licensing, and consulting services for pharmaceutical products navigating UK, US, and global health authority requirements.
Orphan Drugs Regulatory Services
Regulatory compliance and submission services for orphan drugs targeting rare diseases in Europe, the USA, and globally.
UK Responsible Person (UKRP) Services
Comprehensive UK Responsible Person (UKRP) services ensuring seamless market access and compliance for manufacturers in the life sciences industry including medical devices, pharmaceuticals, cosmetics, and advanced therapeutics.
Electronic Common Technical Document
Professional eCTD publishing and regulatory submission support services ranging from Clinical Trial Applications to full Marketing Authorisations.
Regulatory Affairs and Compliance Services
Comprehensive regulatory affairs, compliance, and lifecycle support services for the international life science, pharmaceutical, and healthcare industry.
Orphan Drug Status Services
Regulatory consulting services to help companies apply for orphan drug designation with the EMA and US FDA, enabling access to incentives, fee reductions, and marketing exclusivity.
Pharmaceuticals Regulatory Compliance Services
Regulatory compliance, licensing, and consulting services for pharmaceutical products navigating UK, US, and global health authority requirements.
Orphan Drugs Regulatory Services
Regulatory compliance and submission services for orphan drugs targeting rare diseases in Europe, the USA, and globally.
Services
Consultancy for regulatory strategy, product classification and market entry planning across EU, UK and US jurisdictions.
Preparation and electronic assembly of regulatory dossiers in eCTD format and support for electronic publishing and submissions.
Managed pharmacovigilance services covering safety monitoring, case processing and regulatory reporting.
Advice and support on U.S. regulatory requirements and submission pathways for drugs and devices.
Classification, conformity assessment and clinical evaluation support for devices and in‑vitro diagnostics under EU and U.S. frameworks.
Multilingual translation and localisation of regulatory documentation and product information for multi‑jurisdictional filings.
Consultancy for regulatory strategy, product classification and market entry planning across EU, UK and US jurisdictions.
Preparation and electronic assembly of regulatory dossiers in eCTD format and support for electronic publishing and submissions.
Managed pharmacovigilance services covering safety monitoring, case processing and regulatory reporting.
Advice and support on U.S. regulatory requirements and submission pathways for drugs and devices.
Classification, conformity assessment and clinical evaluation support for devices and in‑vitro diagnostics under EU and U.S. frameworks.
Multilingual translation and localisation of regulatory documentation and product information for multi‑jurisdictional filings.
Expertise Areas
- Regulatory compliance and strategy (EU, UK, US)
- Medical device and IVD conformity and clinical evaluation
- Pharmacovigilance and post‑market safety
- eCTD dossier management and electronic submissions
Key Technologies
- Electronic Common Technical Document (eCTD) assembly
- Pharmacovigilance systems and safety reporting workflows
- Regulatory pathway frameworks for FDA and EMA submissions
- Device classification and conformity assessment processes
News & Updates
Awarded SME status by the European Medicines Agency, enabling access to SME incentives and fee reductions for eligible clients.
Listed as a winner on the organisation's Biotechnology Awards page (referenced on the company awards page).
Presence of an Innovation & Excellence award image on the company awards page.
Awarded SME status by the European Medicines Agency, enabling access to SME incentives and fee reductions for eligible clients.
Listed as a winner on the organisation's Biotechnology Awards page (referenced on the company awards page).
Presence of an Innovation & Excellence award image on the company awards page.