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 The IDAProvides 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 Regulatory TrainingRegulatory training is a mandatory requirement for all personnel involved in the research, development, and submission of medicinal products within the United Kingdom. Mastering the complexities of the Medicines and Healthcare products Regulatory Agency (MHRA), the UK's post-Brexit regulatory framework, and ICH guidelines is essential for successful market access and compliance.
The Medicines and Healthcare products Regulatory Agency (MHRA) conducts GMP, GCP, GLP, and GDP inspections of pharmaceutical manufacturers, clinical trial sites, and logistics providers across the UK. Inadequate regulatory training can lead to serious findings that impact your organization's ability to operate and market products in the UK market.
Common MHRA inspection observations related to regulatory and quality training include:
Our 21 CFR Part 11 compliant certificates provide auditable, documented training records that FDA investigators accept during inspections.
The UK has established a robust, independent regulatory framework post-Brexit, while maintaining strong alignment with international standards. This ensures UK professionals are equipped for both domestic compliance and global market access.
The Medicines and Healthcare products Regulatory Agency (MHRA) continues to align its technical requirements with ICH guidelines and, where appropriate, EU GMP/GDP standards. This means training that covers these harmonised principles is directly applicable to UK professionals, ensuring your knowledge remains valid for both UK submissions and international projects.
UK-trained regulatory professionals and MHRA-compliant facilities are held in high regard globally. Our training programs cover the core regulatory principles recognised by major authorities worldwide, including the FDA, EMA, and WHO, facilitating your company's entry into key international markets.
UK-based pharmaceutical companies, sponsors, and CROs frequently operate in a multi-market environment, supplying the US, EU, and other regions. Our regulatory affairs courses are designed to cover all relevant frameworks (MHRA, FDA, EU, ICH) in a single, comprehensive program, making it easier for your team to manage global submissions and maintain compliance across borders.
Need to upskill your entire regulatory, clinical, or quality team? We offer flexible group enrollment options for UK companies of all sizes, from small biotechs to large pharmaceutical organisations. Get a custom quote for your team within 24 hours.
| Feature | GxP Trainings |
|---|---|
| MHRA & UK Framework | |
| ICH Guidelines (E, M, Q, S Series) | |
| CTD/eCTD Format | |
| UK Clinical Trials Framework | |
| ICH Q9 (Quality Risk Management) | |
| MHRA Inspection Readiness | |
| 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 MHRA, EU GMP, FDA, and WHO inspection readiness.