GMP / cGMP Certification
We certify your facility for U.S. markets.
From gap assessment to certification-ready systems. We help you implement GMP/cGMP and prepare your facility for U.S. regulatory requirements with confidence.
- Criteria based on 21 CFR
- Expert Guidance
- Real Opportunities
Choose Your Industry
Tailored GMP Solutions for Your Products
-
Food GMP
21 CFR Part 117Current good manufacturing practice and preventive controls for human food.
-
Dietary Supplement GMP
21 CFR Part 111cGMP for manufacturing, packaging, labeling and holding of supplements.
-
Cosmetic GMP
FDA cosmetic GMP guidanceGood manufacturing practices for cosmetic and personal care facilities.
Access FDA GMP Assessment & Certification Program
We evaluate your facility against a defined scope and criteria grounded in the applicable regulations, close the gaps with your team and, when the facility meets the program criteria, issue a private Access FDA certificate that documents it.
- Scope, criteria and methodology agreed in writing before the assessment.
- On-site or remote evaluation according to the contracted scope.
- A private certificate tied to your facility only; it cannot be transferred to another entity.
Our GMP Services
Everything You Need for a Certified and Compliant Facility
-
GMP Gap Assessment
We evaluate your current facility and identify gaps.
-
SOP Development & Implementation
Standard operating procedures tailored to your operation.
-
Quality Systems
Documentation, record-keeping and continuous improvement.
-
Personnel Training
We train your team on GMP/cGMP requirements.
-
Internal Audits & Mock FDA Inspection
Be prepared for FDA visits and customer audits.
-
Certification Support
We guide you until your facility meets the program criteria.
Our Process
A Clear Path to Certification
-
Assessment
On-site or remote evaluation.
-
Action Plan
Customized roadmap for compliance.
-
Implementation
Development and execution.
-
Validation
Verification through audits and training.
-
Certification Ready
Your facility prepared for U.S. opportunities.
GMP Certification with Confidence
We work closely with your team until your facility meets the GMP/cGMP criteria of the program, prepared for U.S. regulatory requirements, inspections and commercial opportunities.
Request GMP Assessment
Key FDA Regulations
Built on Regulatory Standards
| Reference | Scope | Applies to |
|---|---|---|
| 21 CFR Part 117 | Current Good Manufacturing Practice, Hazard Analysis and Risk-Based Preventive Controls for Human Food | Food and beverage facilities |
| 21 CFR Part 111 | Current Good Manufacturing Practice for Dietary Supplements | Supplement manufacturers, packers, labelers and holders |
| FDA cosmetic GMP guidance | FDA guidance on good manufacturing practices for cosmetics | Cosmetic and personal care facilities |
| 21 CFR Parts 210 & 211 | Current Good Manufacturing Practice for finished pharmaceuticals | OTC drug and antiseptic manufacturing, when applicable |
Frequent Questions
GMP / cGMP Compliance — FAQs
Do I need GMP certification to export to the U.S.?
FDA does not issue GMP certificates to food, supplement or cosmetic facilities. It requires compliance with the regulations that apply to your products and it may inspect your facility. Importers and buyers often ask for independent evidence; our private certificate documents your facility against the program criteria.
What is the difference between GMP and cGMP?
cGMP means current good manufacturing practice: the requirements as they apply today. FDA rules for food (21 CFR 117) and dietary supplements (21 CFR 111) are both current GMP rules, so the terms are often used interchangeably.
How long does the GMP implementation process take?
It depends on the size of the facility and the gaps found. After the assessment we share an action plan with a timeline you can plan around.
Do you provide on-site audits or virtual assessments?
Both. The contracted scope defines whether the evaluation is on-site, remote or a combination.
Can you help with SOPs and training?
Yes. We write and implement SOPs with your team and train personnel on the GMP/cGMP requirements that apply to your operation.
Do you support facilities outside Mexico?
Yes. We work with facilities outside the United States; travel and on-site work are quoted per project.
Ready to Certify Your Facility?
Let's talk about your project. Our team is here to help.