Hameed Faheem P.

I find what the auditor finds. First. Most regulatory and quality problems are not dramatic. They are one small mismatch between two records: a revision cited in one place and not in another, a claim on a label that the file doesn't support, a CAPA closed before the evidence was complete. Auditors find these. I find them first. I'm a PharmD, registered pharmacist and MSc in Regulatory Affairs, based in Dublin. I work on both sides of compliance, regulatory and quality, so you don't need two people to get one answer. WHAT I DO • CAPA, deviation and GMP documentation review • Batch record review and SOP drafting and revision under document control • EU MDR documentation: classification, GSPR checklists, risk management, technical file gap checks • Label, claim and compliance reviews for supplements, cosmetics and pharma • Regulatory writing that is checked against its sources, with claims linked to citations HOW I WORK • I check every document against the records it cites. • I use AI to draft faster, and every sentence is human-edited and fact-checked before it reaches you. • I tell you what I can't confirm instead of guessing. If a requirement is unclear, I flag it for review. • Clear, plain-English deliverables you can use as they are. PROOF I've reviewed 120+ batch records and managed 75+ controlled documents in pharmaceutical manufacturing environments, and I've built a set of MDR sample documents that you can view in my portfolio WORKING WITH ME Send me the document, the file or the question. I'll tell you straight what I'd fix first and what it will take. Fixed-price scopes and clear milestones are welcome.