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.
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 |
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.
Comprehensive certification covering the global pharmaceutical regulatory landscape. This program provides end-to-end knowledge of the drug development lifecycle with a strong focus on the regulatory frameworks that UK professionals must navigate, including the MHRA, EMA (for historical context and ongoing global strategy), and FDA requirements. It covers all major application types (IND, NDA, ANDA, BLA), providing a truly global perspective.
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 NDAProvides 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 SpecialistsProvides 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 ApplicationCovers 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 NDAProvides 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 TrainingRegulatory training is a mandatory requirement for all personnel involved in the research, development, and commercialization of medicinal products in the UK.
The FDA conducts inspections of pharmaceutical manufacturers, distributors, and logistics providers. Inspection findings can have serious consequences:
Common FDA GDP inspection observations include:
Our 21 CFR Part 11 compliant certificates provide auditable, documented training records that FDA investigators accept during inspections.
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 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.
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.
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.
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.
| 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 |
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.
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.
Yes. We offer corporate and group enrollment options for teams of all sizes. Contact us for a custom quote.
All courses include lifetime access — study at your own pace, on your own schedule.
Yes. Each certificate includes a unique verifiable ID that can be checked at gxptrainings.com/verify-certificate/
Equip yourself and your team with the Regulatory Affairs knowledge and documented training records required for Health Canada, FDA, and WHO inspection readiness.