Mike B.

Is your Product brand really compliant in every market you sell in? Or are there gaps you haven’t spotted yet? That is where I come in: As a Certified Chemist and regulatory Specialist, I help brands launch and sell products that are compliant, properly documented, and ready for regulatory scrutiny in the EU, UK, and US Markets. As a PharmD-trained Product Compliance Specialist with a background in formulation chemistry, I don’t just check documents. I look at what is in your product, how it is formulated and manufactured, how its claims are supported, and whether the whole story holds together from a regulatory standpoint. ✅ HOW I HELP CLIENTS 🔴 Product Compliance Review Full review of formulations, labels, claims, and documentation to identify compliance gaps before they become costly launch delays or market-access problems. 🔴 GMP Readiness & Support Gap assessments and documentation support aligned with cosmetic GMP (ISO 22716), plus support responding to inspection findings and corrective actions. 🔴 Multi-Market Regulatory Support Guidance for placing products on the EU, UK, and US markets, so your documentation and labelling stay consistent across regions. 🔴 Formulation & Ingredient Review Checking ingredients against restrictions, prohibited-substance lists, and safety requirements to flag issues early in product development. 🔴 CORE SERVICES EU & UK Cosmetics ◆ EU Cosmetics Regulation (EC) No 1223/2009 compliance review ◆ CPNP notifications ◆ UK SCPN notifications ◆ UK CPSR and EU CPSR support ◆ Product Information File (PIF) review and preparation ◆ Label and claims review ◆ Responsible Person documentation support US & International ◆ MoCRA compliance (facility registration, product listing, safety substantiation, labelling) ◆ FDA cosmetic labelling and claims review ◆ TGA cosmetics requirements ◆ Health Canada cosmetics requirements GMP & Quality ◆ GMP gap assessments (ISO 22716) ◆ SOP and quality documentation review ◆ Inspection-readiness support ◆ GMP inspection report responses ◆ FDA 483 response documentation Also supported ◆ Dietary supplement and nutraceutical compliance (FDA DSHEA, EU notifications) ◆ Medical device and pharmaceutical regulatory documentation MY APPROACH ✓ Science-first: evidence and regulatory requirements lead every decision ✓ Detail-oriented: I focus on the gaps that cause problems later ✓ Practical: recommendations fit your product and commercial goals ✓ Clear communication: no unexplained regulatory jargon ✓ Quality-focused: documentation prepared with inspection and scrutiny in mind ✓ Deadline-conscious: clear deliverables and realistic timelines from the start WHAT CLIENTS SAY ⭐ "Clear, careful work. Mike delivered two well-structured regulatory case briefs with decisive record details, and fixed the first one quickly after review. Easy to work with." ⭐ "Would recommend using Mike - was easy to communicate with and head deadlines set which he beat everytime!" If you need a compliance professional who understands both the science behind your product and the regulations that govern it, I’d be glad to discuss your project.