Shaheen Fathima A.

ABOUT ME Got a refusal letter, a Form 483, or a deficiency report, and a deadline? That's the work I do. I'm a RAC-Drugs (Global) and ICH-GCP certified regulatory consultant. I take submissions that were refused, rejected, or flagged and rebuild them so they can go back in, across FDA, the EU, Health Canada, TGA, MHRA, and SwissMedic. WHAT I'VE HANDLED: 25+ refusal, rejection, and inspection cases - FDA: Refuse-to-File (NDA, BLA), Refuse-to-Receive (ANDA), Refuse-to-Accept (510(k), De Novo), Form 483 responses, orphan designation remediation - EU: Statements of Non-Compliance - Inspection report responses: Health Canada, TGA, SwissMedic, MHRA HOW I WORK - I read the letter against the regulation and your original submission, then tell you plainly what is fixable and what isn't. - I write the response and rebuild the affected sections around how the agency actually evaluates them. - For inspection findings, a response is only as strong as the corrective action behind it, so I tell you what has to change on your side, not just on paper. - The person who writes your response is the person you talk to. No juniors, no handoffs. ALSO: EU MDR/IVDR CLINICAL EVALUATION Systematic literature reviews and state-of-the-art sections for clinical and performance evaluation of 5 regulated products (Class IIa devices, Class B and C IVDs, Health Canada Class II), including 2 solo-authored SLRs, all reviewed by a Notified Body or Health Canada. PRISMA-documented searches across PubMed/MEDLINE, Embase, and Cochrane, aligned to MEDDEV 2.7/1 Rev 4 and MDR Annex XIV. ALSO: IND/NDA/ANDA/BLA documentation (Modules 2-5), eCTD publishing, global labeling, and UAE (MOHAP) registration. ALSO: Medical device regulatory support across FDA (PMA, 510(k)), EU MDR, TGA, HSA, and Health Canada, and DME/HCPCS coding (CPC, CCS, COC certified). Top Rated Plus, 100% Job Success Score. Send me the letter and your deadline (redact anything identifying until we've agreed to work together), and I'll tell you how I'd approach it.