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Regulatory Affairs Training in the UK

Regulatory Affairs Training in the UK

Comprehensive online regulatory training aligned with the Medicines and Healthcare products Regulatory Agency (MHRA), EU GMP, and ICH standards — trusted by UK pharmaceutical professionals, sponsors, and CROs. Self-paced. 21 CFR Part 11 compliant certificates. Inspection-ready training records for UK regulatory audits.

10+ modules
Regulatory Affairs Courses
21 CFR
Part 11 Compliant Certs
Regulatory Affairs
Regulatory Affairs
MHRA, FDA & ICH
Aligned
Regulatory Context

Regulatory Compliance in the UK: MHRA, UK GMP & ICH Standards

Following Brexit, the UK has established its own independent regulatory framework under the Medicines and Healthcare products Regulatory Agency (MHRA). The framework is based on the Human Medicines Regulations 2012 (as amended). UK regulatory professionals must navigate the new national procedures for Marketing Authorisations, while continuing to align with ICH guidelines to facilitate global submissions. Understanding both the MHRA's unique requirements and the FDA's framework remains critical for UK companies seeking to access the US market.

Agency/Standard Framework Application
MHRA Human Medicines Regulations 2012 Primary legislation for medicinal products in the UK
MHRA UK GMP (Orange Guide) Good Manufacturing Practice for medicinal products
MHRA UK Clinical Trials Framework Regulation of clinical trials in the UK (post-Brexit)
US FDA 21 CFR Parts 50, 56, 312, 314, 600, 601 Essential for submissions to the U.S. market
ICH ICH Guidelines (E, M, Q, S series) International harmonisation for global drug development
The MHRA remains a globally respected authority, and UK professionals must maintain rigorous training to uphold compliance for both domestic and international markets.
Our Courses

Regulatory Affairs Training Courses — MHRA, FDA & ICH Aligned

All courses are self-paced, available online, and include 21 CFR Part 11 compliant certificates with verifiable IDs — accepted as documented training records during regulatory inspections.

For Distributors, Wholesalers & Logistics Teams
Mastering the NDA
Health Canada GDP, WHO GDP guidelines, UK GDP guidelines
$499.00 per person
10 modules Self-paced Certificate included

Covers the entire drug development and approval process for a New Drug Application (NDA) in the CTD format. This training is essential for UK professionals involved in submitting Marketing Authorisation Applications (MAAs) to the MHRA, as the CTD format is the international standard. It also provides critical knowledge for submissions to the FDA.

Enroll in Mastering the NDA
For Distributors, Wholesalers & Logistics Teams
The Investigational New Drug (IND) Framework
Health Canada GDP, WHO GDP guidelines, EU GDP guidelines
$499.00 per person
12+modules Self-paced Certificate included

Provides a comprehensive end-to-end understanding of the IND framework as regulated by the U.S. FDA. This knowledge is critical for UK sponsors and CROs conducting global clinical trials, as it ensures readiness for parallel submissions to the MHRA and FDA.

Enroll in Regulatory Affairs Specialists
For Distributors, Wholesalers & Logistics Teams
Biologics License Application (BLA) Certification Program
Health Canada GDP, WHO GDP guidelines, EK GDP guidelines
$499.00 per person
10 modules Self-paced Certificate included

Provides comprehensive knowledge of the planning, preparation, and submission of BLAs to the FDA. This is crucial for UK biotech companies seeking to enter the US market. The course covers the full eCTD structure, CMC, nonclinical and clinical data, and FDA review processes, which are directly applicable to preparing files for the MHRA.

Enroll in Biologics License Application
For Canadian Manufacturers Supplying the USA Market
Mastering the Orphan Drug NDA
Parts I & II, Annex 1 (revised 2022), Annex 11, Annex 15
$499.00 per person
10modules Self-paced Certificate included

Covers the entire orphan drug development process, including the US Orphan Drug Act. This is highly relevant for UK companies developing therapies for rare diseases, who often seek orphan designation from both the MHRA (using EU rules) and the FDA for US market access.

Enroll in Mastering the Orphan Drug NDA
For Canadian Manufacturers Supplying the USA Market
ANDA Compliance and Regulatory Training
Parts I & II, Annex 1 (revised 2022), Annex 11, Annex 15
$499.00 per person
10modules Self-paced Certificate included

Provides an in-depth understanding of the regulatory requirements for preparing and submitting ANDAs to the FDA. This is vital for UK-based generic pharmaceutical companies looking to export to the lucrative U.S. market.

Enroll in ANDA Compliance and Regulatory Training
Who Needs Training

Who Needs Regulatory Training in the UK?

Regulatory training is a mandatory requirement for all personnel involved in the research, development, and commercialization of medicinal products in the UK.

Warehousing & Storage
  • Warehouse managers, supervisors, and operators
  • Cold chain and temperature monitoring specialists
  • Inventory and stock rotation personnel
  • Returns and quarantine handlers
Transportation & Distribution
  • Transport managers and fleet supervisors
  • Logistics coordinators and dispatchers
  • Drivers handling temperature controlled deliveries
  • Shipping and receiving staff
Quality & Compliance
  • Quality Assurance (QA) managers and officers
  • GDP compliance officers
  • Internal auditors
  • Responsible Persons (RPs) and deputies
  • Regulatory Affairs (RA) managers
Contract Services
  • Third party logistics (3PL) providers
  • Contract warehouse operators
  • Distribution service providers
  • Importers and exporters of pharmaceutical products
Health Canada Inspections

GDP Inspections, Compliance Risk & Training Records

What Happens When GDP Training Falls Short

The FDA conducts inspections of pharmaceutical manufacturers, distributors, and logistics providers. Inspection findings can have serious consequences:

  • Warning Letters — FDA warning letters are published publicly and can damage reputation
  • Import Alerts — Products may be detained at the border
  • Consent Decrees — Court-enforced agreements with significant oversight costs
  • Product Recalls — Costly and damaging to brand trust
  • Criminal Prosecution — In cases of deliberate non-compliance

Common FDA GDP inspection observations include:

  • Inadequate temperature monitoring and control
  • Poor training records and undocumented training
  • Insufficient excursion investigations
  • Lack of written agreements with contract acceptors
  • Inadequate supply chain security measures (DSCSA compliance)
Inspection Ready Training Records

Our 21 CFR Part 11 compliant certificates provide auditable, documented training records that FDA investigators accept during inspections.

Unique verifiable certificate ID — check at gxptrainings.com/verify-certificate/
Includes completion date, course name, and assessment score
Downloadable PDF — upload to any QMS or LMS
Accepted by FDA inspectors
Satisfies FDA 21 CFR Part 211.25 (personnel qualifications) and GDP training requirements
Canada's PIC/S Membership

Canada’s Membership in PIC/S — Why It Matters for Your GDP Training

Canada joined the Pharmaceutical Inspection Co operation Scheme (PIC/S) — the international body that harmonises GMP and GDP standards across 55 member countries. This has direct implications for how GDP training is structured for Canadian professionals.

Health Canada Aligned with EU GDP

Health Canada GDP requirements are closely aligned with EU GDP and WHO GDP — meaning training that covers PIC/S harmonised GDP principles is relevant for Canadian professionals working in any international context.

International Recognition

Canadian facilities with Health Canada GDP certification are recognised by many international regulators. Our training covers the core GDP principles recognised by all PIC/S member authorities — including FDA, EMA, and WHO.

Multi Market Compliance

Canadian distributors supplying the US, EU, or other markets must meet multiple regulatory frameworks simultaneously. Our GDP courses cover all relevant frameworks in a single, comprehensive program.

Corporate Training for Canadian Logistics Companies

Training your entire QA, warehouse, or transport team? We offer group enrollment for Canadian pharmaceutical logistics companies of all sizes. Group quotes provided within 24 hours.

Corporate Training Packages
Why GxP Trainings

Why Choose GxP Trainings for GDP Auditor Certification

Feature GxP Trainings
FDA 21 CFR Part 205 aligned
FDA 21 CFR Parts 210 & 211 aligned
DSCSA requirements covered
DSCSA requirements covered
PIC/S GDP Guide (PE 011 1) covered
WHO GDP aligned
ICH Q9 (Quality Risk Management) covered
21 CFR Part 11 compliant certificate
Self paced — study on your schedule
Instant certificate download
Verifiable certificate ID
Group / corporate enrollment
FAQs

Frequently Asked Questions

Q Is online regulatory training accepted by the MHRA?

Yes. The MHRA accepts documented, role-appropriate training. Our 21 CFR Part 11 compliant certificates provide verifiable proof of training that is accepted during GCP, GLP, and GMP inspections.

Q Does this training reflect the UK's post-Brexit regulatory environment?

Yes. The Certified Regulatory Affairs Professional (CRAP) course covers the global landscape, providing a framework to understand the MHRA's new independent role while maintaining the global perspective necessary for ICH and US submissions.

Q Do you offer group discounts for UK companies?

Yes. We offer corporate and group enrollment options for teams of all sizes. Contact us for a custom quote.

Q How long do I have access to the course?

All courses include lifetime access — study at your own pace, on your own schedule.

Q Are the certificates verifiable?

Yes. Each certificate includes a unique verifiable ID that can be checked at gxptrainings.com/verify-certificate/

Start Your Regulatory Affairs Training Today

Equip yourself and your team with the Regulatory Affairs knowledge and documented training records required for Health Canada, FDA, and WHO inspection readiness.

10 modules Self-paced Health Canada, FDA & WHO aligned 21 CFR Part 11 compliant certificate $799
Enroll in Regulatory Affairs — $799