Book a free discovery call and get a clear picture of your compliance gaps, certification options, and what it takes to get GMP certified.
Tell us about your facility, current documentation status, production volume, and the certification or channel access you're working toward.
Based on what you share, we'll tell you exactly which of our 6 roadmap phases you're starting from and what that means for your timeline.
You'll leave the call with a clear understanding of the certifications you need, the services required to get there, and a realistic timeline estimate.
The discovery call is for your benefit. If we're the right fit, we'll propose an engagement. If not, we'll tell you that too.
Fill out the form and our compliance team will reach out within 1 business day.
We'll be in touch within 1 business day.
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The timeline depends on your starting point — how much existing documentation you have, whether you've had prior FDA inspections, your facility readiness, and which certification body you're targeting. For operations starting from scratch, 6–9 months is a realistic range. Facilities with existing documentation and systems in place often reach certification in 4–6 months. We'll give you a specific estimate during your discovery call after reviewing your current situation.
You can absolutely start partway through. If you already have SOPs, an existing QMS, or have completed a prior gap assessment, we assess what you have and scope the engagement starting from wherever you actually are. We won't charge you to redo work that already meets certification standards. The discovery call is the right place to assess your starting phase.
Yes — FDA 483 response is one of our core services. We help you draft substantive responses that address the root causes of each observation, commit to verifiable corrective actions with realistic timelines, and position your response favorably for FDA's follow-up review. We also help you implement the corrective actions so your next inspection results in a clean record. If you've received a 483, contact us promptly — FDA response deadlines are important.
21 CFR Part 111 is FDA's mandatory Current GMP regulation — every dietary supplement manufacturer is legally required to comply with it, and FDA inspectors enforce it. NSF/ANSI 455-2 GMP certification is a voluntary third-party certification that demonstrates compliance to an independent auditor. NSF certification is what many retailers, Amazon, and pharmacy channels require as a condition of carrying your products. Our roadmap prepares you for both simultaneously, since the requirements are closely aligned.
Yes, we work with both. Contract manufacturers engage us to build or remediate their own GMP programs so they can attract and retain brand owner clients who require certified manufacturing partners. Brand owners engage us to audit and qualify their CMOs, or to build internal quality oversight programs. The discovery call helps us understand which situation applies to you and scope accordingly.
Book your free discovery call today. No obligation — just a clear picture of your path to certification.
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