Microbiology and quality support for cosmetics makers
Indie and growing cosmetics brands often find that the regulatory side moves faster than they can follow. MoCRA added facility registration (renewed every two years), product listing (updated annually), serious adverse event reporting to FDA within 15 business days, and safety substantiation records. FDA is required to issue cosmetic GMP regulations but has not finalized them. Some small businesses are exempt from GMP, registration and listing. Having submitted the paperwork doesn't mean your product is safe or your process is under control. We help cosmetics and personal care makers build both.
Will your formula stay safe in use?
Water-based products, natural preservative systems and multi-use packaging all raise microbial risk. We help you plan preservative efficacy (challenge) testing and microbial limit testing, using recognized methods such as ISO 11930 or USP <51>, chosen with your lab, and understand what a pass, fail or borderline result means for your formula and packaging decisions. We coordinate the testing; outside labs perform it.
A GMP baseline sized for your operation
Until FDA finalizes cosmetic GMP regulations under MoCRA, ISO 22716 is a widely used voluntary standard to work from. We assess your batch records, raw material control, water system, cleaning and complaint handling against it, then turn the gaps into a short, prioritized plan. That plan works whether you fill in-house or use a contract manufacturer.
Working with contract manufacturers
If someone else makes your product, you still own its safety. We help you set specifications, decide what to ask your filler for, review their documentation, and plan for supplier audits.
Fill rooms and water
For brands with their own production, we design practical environmental monitoring for fill areas and help you trend water system results, so problems show up before a batch fails.
Where engagements usually start
Many cosmetics brands reach us when they move from small handmade batches to a larger run or a contract filler, when a retailer asks for test data, or when a product changes color, smell or texture on the shelf. We start with your formulas, packaging and current test results, explain in plain English what each regulation and test is for, and agree a short, fixed-scope plan. You'll know which tests to order and why, rather than paying for tests by guesswork.
Related services
Frequently asked questions
Is cosmetic GMP required in the U.S. today?
Not as a final regulation yet. MoCRA requires FDA to issue cosmetic GMP regulations, and FDA has published draft guidance. Until the rules are final, ISO 22716 is a widely used voluntary baseline. We'll keep this answer current.
Do you certify to ISO 22716?
No. We help you prepare. Certification, if you want it, comes from an independent body.
Can you help with halal for export?
Yes. We prepare you for a halal certifier's review.
Plan your challenge testing with us or start with the checklist.