The regulations you actually have to pass — in plain English.
45 clause-by-clause readiness guides across pharma, medical devices, food and cosmetics. Each one ends with the evidence inspectors ask for and a 60–90 day path to get there.
21 CFR Part 11 Readiness Guide for Regulated Manufacturers
Plain-English guide to FDA 21 CFR Part 11 — electronic records, electronic signatures, audit trails, and a practical path to a Part 11-compliant eQMS without theatre.
Pharma & GxP
Drug manufacturing, distribution, and electronic records.
21 CFR 211 Drug cGMP
Plain-English guide to 21 CFR Part 211 — current Good Manufacturing Practice for finished pharmaceuticals. Subparts B through K, data integrity, ALCOA+, and an FDA inspection-ready path.
21 CFR Part 11
Plain-English guide to FDA 21 CFR Part 11 — electronic records, electronic signatures, audit trails, and a practical path to a Part 11-compliant eQMS without theatre.
DSCSA
Plain-English guide to the Drug Supply Chain Security Act (DSCSA) — serialization, aggregation, EPCIS exchange, verification, and the path through enhanced drug distribution security.
EU Falsified Medicines Directive
Plain-English guide to the EU Falsified Medicines Directive 2011/62/EU and Delegated Regulation 2016/161 — unique identifier, tamper-evident features, EMVS connection and the path to clean dispense-time verification.
EU GDP
Plain-English guide to EU Good Distribution Practice (2013/C 343/01) — Responsible Person duties, temperature control, qualifications, falsified medicines, and inspection.
EU GMP Annex 1 Sterile Manufacturing
Plain-English guide to the 2022 revision of EU GMP Annex 1 — sterile medicinal products. Contamination Control Strategy, QRM, grade A/B/C/D, barrier technology and aseptic process simulation.
EU GMP Annex 11
A practical, audit-ready walkthrough of EU GMP Annex 11 — what each clause means, what inspectors look for, and how to evidence compliance for any GxP system.
EU GMP for Medicinal Cannabis
EU GMP readiness for medicinal cannabis cultivators, extractors and finished-product manufacturers — Part I, Annex 7 (herbal), Annex 1 (sterile), QP release and EU-GMP certification.
GAMP 5 & FDA CSA
Plain-English guide to GAMP 5 second edition and FDA's Computer Software Assurance — software categories, risk-based testing, intended use, and a leaner validation pack.
ICH Q10 Pharmaceutical Quality System
Plain-English guide to ICH Q10 — the global Pharmaceutical Quality System. Management responsibilities, lifecycle stages, enablers, and a practical implementation path.
ICH Q7 API GMP
Plain-English guide to ICH Q7 — Good Manufacturing Practice for Active Pharmaceutical Ingredients. Process step boundaries, the API starting material, change control and the FDA/EMA expectations.
ICH Q9(R1) Quality Risk Management
Plain-English guide to ICH Q9(R1) — the international standard for Quality Risk Management in pharmaceuticals. Subjectivity, formality, hazard ID, and a QRM programme inspectors trust.
USP <797> Sterile Compounding
Plain-English guide to USP General Chapter <797> — pharmaceutical compounding of sterile preparations. Category 1, 2 and 3 CSPs, the BUDs, the cleanroom design, and a path to a clean state-board inspection.
Medical Devices & IVD
Device QMS, technical documentation, and software lifecycle.
EU IVDR
Plain-English guide to Regulation (EU) 2017/746 — the In Vitro Diagnostic Regulation. Risk classes, performance evaluation, notified body involvement, and a path through the transition deadlines.
EU MDR Technical Documentation
Plain-English guide to EU MDR technical documentation — Annex II device file, Annex III post-market surveillance, GSPR, clinical evaluation, and notified-body review.
FDA QMSR Transition Guide: 21 CFR 820 to ISO 13485
Plain-English guide to FDA's Quality Management System Regulation (QMSR) — what changes from 21 CFR 820, what 13485 brings in, and how to transition by 2 February 2026.
IEC 62304 Medical Device Software
Plain-English guide to IEC 62304 — the lifecycle standard for medical device software. Safety classes, SOUP, problem resolution, and a software file that survives audit.
ISO 13485
Plain-English guide to ISO 13485:2016 — the QMS standard for medical devices. Scope, process approach, risk, design controls, and a realistic certification path.
ISO 14971 Risk Management
Plain-English guide to ISO 14971:2019 — the risk management standard for medical devices. Hazards, harms, risk control, residual risk, and a living risk management file.
MDSAP
Plain-English guide to the Medical Device Single Audit Program — one audit, five regulators (US, Canada, Brazil, Australia, Japan). Audit model, grading, country-specific add-ons, and a path to a clean report.
Food Safety
HACCP, GFSI schemes, and FSMA traceability rules.
BRCGS Food Safety Issue 9
Plain-English guide to BRCGS Global Standard for Food Safety Issue 9 — fundamentals, HACCP, food safety culture, unannounced audits, and a path to AA grade.
FSMA 204 Food Traceability
Plain-English guide to FDA FSMA Section 204 — the Food Traceability List, Key Data Elements, Critical Tracking Events, and how to be 24-hour-ready before the January 2026 deadline.
FSMA Preventive Controls & PCQI
Plain-English guide to FSMA Preventive Controls for Human Food (21 CFR 117) — the food safety plan, hazard analysis, PCQI duties, and a realistic readiness path.
FSSC 22000
Plain-English guide to FSSC 22000 v6 — ISO 22000, sector PRPs, and the additional FSSC requirements that auditors actually focus on during certification.
FSVP
Plain-English guide to FDA's Foreign Supplier Verification Program — hazard analysis, supplier evaluation, verification activities, and the records FDA actually inspects.
HACCP Codex
Plain-English guide to HACCP per Codex Alimentarius CXC 1-1969 Rev.5 (2020) — the seven principles, the twelve logic steps, prerequisite programmes and a plan that survives any GFSI audit.
IFS Food Version 8
Plain-English guide to IFS Food Version 8 — the GFSI-recognised standard used across European retail. KO requirements, scoring, unannounced audits and a path to a Higher Level certificate.
ISO 22000:2018 Food Safety Management
Plain-English guide to ISO 22000:2018 — the international food safety management standard. PDCA, HACCP, PRPs, the operational PRP concept and a path to a clean certification audit.
SQF Edition 9 Food Safety
Plain-English guide to the SQF Food Safety Code Edition 9 — system elements, food safety culture, environmental monitoring, unannounced audits and a path to a clean SQF certificate.
Cosmetics
MoCRA and ISO 22716 cosmetics GMP.
ISO 22716 Cosmetics GMP
Plain-English guide to ISO 22716 — Good Manufacturing Practices for cosmetics. EU Regulation 1223/2009 link, premises, production, laboratory, internal audits and the path to a clean inspection.
MoCRA
Plain-English guide to the Modernization of Cosmetics Regulation Act — facility registration, product listing, safety substantiation, adverse-event reporting, and GMPs for cosmetics sold in the US.
Quality Systems
Cross-industry quality management foundations.
AABB Blood Bank Standards
Readiness guide for blood banks and transfusion services against the AABB Standards for Blood Banks and Transfusion Services (33rd ed.) and 21 CFR 600/606/610.
US Cannabis State GMP
Readiness guide for licensed cannabis cultivators, manufacturers and processors — state GMP rules (FOCUS, ASTM, AHPA), seed-to-sale, testing, recall and inspection.
Cannabis Traceability & Recall
Practical guide to cannabis traceability and recall — METRC and equivalent systems, ASTM D8434 safety standards, state recall rules, complaint handling and adverse event reporting.
EPA FIFRA Pesticide Manufacturing
Readiness guide for pesticide registrants and producers under FIFRA — Section 3 registration, establishment registration (Section 7), Section 6 reporting, label compliance and EPA inspections.
EU 10/2011 Plastics Food-Contact
Readiness guide for plastic food-contact materials under Commission Regulation (EU) 10/2011 — Union List, SML, OML, NIAS, declaration of compliance and supporting documentation.
EU Cosmetics Regulation 1223/2009
Plain-English readiness guide to EU Regulation (EC) 1223/2009 — Responsible Person, PIF, CPNP notification, safety assessment, labelling and post-market surveillance.
EU REACH for Agrochemicals
How REACH (EC) 1907/2006 interacts with EU pesticide regulation 1107/2009 — registration boundary, SVHC, authorisation, restrictions and supply-chain documentation for agrochemical manufacturers.
EU Tissues & Cells Directive 2004/23/EC
Readiness guide for EU tissue and cell establishments — Directive 2004/23/EC, implementing Directives 2006/17 and 2006/86, the SoHO Regulation transition and competent authority inspection.
FDA 21 CFR 1271 HCT/P
Readiness guide for human cells, tissues, and cellular and tissue-based products under 21 CFR Part 1271 — registration, donor eligibility, CGTP, adverse reaction reporting and 361 vs 351 boundary.
FDA 21 CFR 177 Food-Contact Polymers
Readiness guide for plastics and resin manufacturers supplying food-contact polymers under 21 CFR 177 — clearance routes, FCN, threshold of regulation, extractables and migration testing.
GLP 40 CFR Part 160
Plain-English guide to EPA Good Laboratory Practice (40 CFR Part 160) for pesticide studies — Study Director, QA Unit, raw data, archival and inspection readiness.
ISO 9001:2015
Plain-English guide to ISO 9001:2015 — the international QMS standard. Risk-based thinking, process approach, leadership and the path to a clean certification audit.
ISO/IEC 17025 Chemical Testing Labs
Plain-English readiness guide to ISO/IEC 17025:2017 for chemical testing laboratories — competence, impartiality, method validation, measurement uncertainty and ILAC-aligned accreditation.
Responsible Care RC14001
Plain-English readiness guide to the American Chemistry Council Responsible Care management system standard RC14001 — EHS&S integration with ISO 14001, Process Safety, Product Safety and Security Codes.
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