Comprehensive online regulatory training aligned with FDA regulations, 21 CFR, and ICH standards — trusted by US pharmaceutical, biotech, and generic drug professionals. Self-paced. 21 CFR Part 11 compliant certificates. Inspection-ready training records for FDA audits.
The U.S. Food and Drug Administration (FDA) enforces one of the most stringent and complex regulatory frameworks in the world for pharmaceuticals and biologics. The framework is built upon the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act, with implementing regulations codified in Title 21 of the Code of Federal Regulations (21 CFR). US regulatory professionals must master the requirements for the full drug development lifecycle, including INDs, NDAs, BLAs, and ANDAs, all while adhering to ICH guidelines for global harmonization.
| Agency/Standard | Framework | Application |
|---|---|---|
| FDA | Federal Food, Drug, and Cosmetic Act | Statutory authority for drug regulation |
| FDA | 21 CFR Parts 200-499, 600-699 | Regulations for drugs, biologics, and devices |
| FDA | 21 CFR Part 312 | Investigational New Drug Application regulations |
| FDA | 21 CFR Part 314 | New Drug Application regulations |
| FDA | 21 CFR Part 601 | Biologics License Application regulations |
| ICH | ICH Guidelines (E, M, Q, S series) | International harmonisation for submissions |
All courses are self-paced, available online, and include 21 CFR Part 11 compliant certificates with verifiable IDs — accepted as documented training records during FDA inspections.
Comprehensive certification covering the global pharmaceutical regulatory landscape. This program provides an end-to-end understanding of the drug development lifecycle with a strong emphasis on the European regulatory environment, including the structure and requirements of the EMA, the Centralised Procedure, and national level submissions. The curriculum is structured to provide foundational regulatory knowledge and advanced strategic capabilities across all major application types.
Provides comprehensive knowledge of the planning, preparation, submission, and review of BLAs to the FDA. The program covers the full eCTD structure, CMC, nonclinical and clinical data, FDA review processes, and inspection readiness. This is essential for the booming US biotech sector.
Enroll in Biologics License ApplicationCovers the entire drug development and approval process, with a deep dive into each component of the New Drug Application (NDA) organized into the five CTD modules. This program is foundational for any professional in the US pharmaceutical industry involved in innovative drug development.
Enroll in Mastering the NDACovers the entire orphan drug development and approval process under the Orphan Drug Act of 1983. Participants learn the step-by-step process for obtaining orphan drug designation from the FDA Office of Orphan Products Development, including benefits like seven-year exclusivity and tax credits.
Enroll in Mastering the Orphan Drug NDAProvides a comprehensive end-to-end understanding of the IND framework as regulated by the FDA. This program covers the legal basis for the IND exemption, the detailed preparation of the initial IND package, the 30-day review timeline, and safety monitoring. It is critical for anyone involved in initiating clinical trials in the US.
Enroll in The (IND) FrameworkProvides an in-depth understanding of the regulatory requirements for preparing and submitting ANDAs to the FDA. This is vital for EU-based generic pharmaceutical companies looking to export to the U.S. market.
Enroll in ANDA ComplianceRegulatory training is mandatory for all professionals involved in the research, development, and submission of FDA-regulated products. Mastering the complexities of the FDA's framework, 21 CFR, and ICH guidelines is essential for successful product approval and market access in the United States.
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.
The US Food and Drug Administration (FDA) operates one of the world's most rigorous and influential regulatory systems. For US pharmaceutical, biotech, and generic drug professionals, mastering FDA requirements is essential—not just for domestic approval, but for global market access, as many international regulators look to FDA standards as a benchmark.
FDA regulations, codified in Title 21 of the Code of Federal Regulations (21 CFR), set the global standard for drug safety, efficacy, and quality. Our training programs are deeply aligned with these core regulations, ensuring that you and your team are equipped to navigate the full drug development lifecycle—from IND to NDA, BLA, or ANDA—with confidence and precision.
The FDA is a founding member of the International Council for Harmonisation (ICH). This means that ICH guidelines (E, M, Q, and S series) are integral to FDA submissions. Our courses cover these harmonised standards, enabling you to prepare submission-ready dossiers that not only meet FDA requirements but are also structured for efficient submissions to other major agencies like the EMA and MHRA.
US-based pharmaceutical companies and biotechs are often global players, supplying markets in the EU, UK, and beyond. Our regulatory affairs courses are designed to cover all relevant frameworks (FDA, ICH, EU, UK) in a single, comprehensive program, making it easier for your team to manage global submission strategies, maintain compliance across borders, and achieve faster market access worldwide.
Need to upskill your entire regulatory, clinical, or quality team? We offer flexible group enrollment options for US companies of all sizes, from emerging biotechs to established multinationals. Get a custom quote for your team within 24 hours.
| Feature | GxP Trainings |
|---|---|
| FDA Submission Pathways (IND, NDA, BLA, ANDA) | |
| ICH Guidelines (E, M, Q, S Series) | |
| CTD/eCTD Format | |
| FDA cGMP (21 CFR Parts 210 & 211) | |
| ICH Q9 (Quality Risk Management) | |
| FDA Inspection Readiness | |
| 21 CFR Part 11 compliant certificate | |
| Self paced — study on your schedule | |
| Instant certificate download | |
| Verifiable certificate ID | |
| Group / corporate enrollment |
The FDA does not pre-approve training providers but expects that personnel are adequately trained. Our 21 CFR Part 11 compliant certificates provide verifiable, auditable proof of training that is widely accepted during FDA inspections.
Under 21 CFR Part 314 and 312, records must be retained for specific periods, often for 2 years after approval or for the duration of the investigation. Our certificates provide permanent, traceable records.
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.