Peptides are transforming health, wellness, and science.
But success in this space requires more than innovation — it requires precision, compliance, and a strong regulatory strategy.

At Compliance Insight, we help organizations working with peptides navigate the evolving FDA landscape with clarity and confidence.

Whether you’re launching a new formulation, expanding a compound pharmacy’s capabilities, or responding to regulatory questions, our team brings the deep expertise and practical tools you need to move forward — compliantly.

We Understand Peptides

Peptides don’t fit neatly into a box. Depending on how they’re used, they might be regulated as drugs, biologics, cosmetics, or something else entirely. That complexity is where we thrive.

Our consultants stay current on FDA guidances, compounding regulations, and the growing scrutiny around GLP-1 analogs, aesthetic peptides, and “research use” disclaimers. We’ll help you understand what’s legal, what’s risky, and what’s possible.

How We Can Help

Regulatory Classification & Pathway Development
We determine where your product fits in the FDA framework — and what steps you need to take to market it legally.

Compounding Compliance (503A & 503B)
We assist pharmacies and outsourcing facilities in understanding FDA expectations for peptides, including, drug shortages lists, bulk lists, USP/NF monographs and ISO 5 expectations.

Label & Advertising Review
From cosmetic actives to therapeutic claims, we review your marketing for compliance and recommend defensible language that still resonates with customers.

Quality Systems & SOP Support
We help you build the infrastructure behind compliant operations — from documentation to deviation handling.

Audit Readiness & Inspection Support
We prepare your team for inspections and assist with responses to 483s, Warning Letters, or import holds.

Enforcement & Risk Strategy
Whether you’re facing a Warning Letter or want to avoid one, we develop proactive plans that align with FDA and DOJ priorities.

Your Trusted Partner in Peptide Compliance

With more than 25 years supporting FDA-regulated businesses, we bring perspective, practical know-how, and regulatory rigor to every project.

We don’t just interpret the rules — we help you apply them in ways that make business sense.