Imran K.

Sr. FDA Regulatory Affairs & Compliance Consutant | Durgs & Devices

FDA Regulatory Consultant | 510(k) · 505(b)(2) · DSHEA · PharmD | AI-Augmented Compliance Services for Pharma & Supplement Brands Hello! I am a Senior FDA Regulatory Affairs and Compliance Pharmacist with strong expertise in pharmaceuticals, dietary supplements, medical devices, and healthcare regulatory consulting, combined with high-level academic and scientific writing experience. I help pharma companies, supplement brands, medical device manufacturers, healthcare startups, and research organizations successfully navigate FDA, EMA, and Health Canada regulatory requirements while ensuring their documentation, submissions, and publications meet global compliance and scientific standards. With 5+ years of experience in regulatory strategy, FDA compliance, regulatory submissions, and academic research writing, I provide end-to-end regulatory and scientific support, from early-stage planning to final submission, audit readiness, and publication. Whether you need help with FDA 510(k) submissions, dietary supplement compliance, orphan drug pathways (502b), or peer-reviewed academic writing, I ensure your work is accurate, compliant, defensible, and professionally presented. Regulatory Affairs & Compliance Services ✔ FDA Regulatory Affairs & Compliance Consulting ✔ FDA 510(k) Medical Device Submission Support ✔ FDA 502b / Orphan Drug Regulatory Strategy ✔ Dietary Supplement FDA Compliance (DSHEA, labeling, claims review) ✔ Regulatory Submission Preparation & Review ✔ Regulatory Pathway & Strategy Development ✔ FDA, EMA & Health Canada Compliance Alignment ✔ Risk Assessment, Gap Analysis & Mitigation Planning ✔ Quality Assurance & Regulatory Documentation Review ✔ Audit Readiness & Compliance Verification ✔ Stakeholder Communication & Regulatory Advocacy ✔ Cross-functional Regulatory Collaboration Academic, Scientific & Medical Writing Expertise ✔ Academic & Scientific Writing (Pharma & Healthcare) ✔ Medical Research Paper Writing ✔ Journal Articles & Manuscripts (Publication-Ready) ✔ White Papers & Technical Reports ✔ Literature Review & Research Synthesis ✔ Scientific Data Analysis & Interpretation ✔ Drug Chemistry & Formulation Reviews ✔ Evidence-Based Regulatory & Scientific Documentation All content is well-researched, properly cited, and aligned with journal and regulatory standards. Supplement, Formulation & Research Services ✔ Dietary Supplement Optimization Research ✔ Formulation & Ingredient Sourcing ✔ Raw Material & Drug API Resourcing ✔ Claims Substantiation & Label Compliance Review ✔ Research-Based Ingredient & Safety Analysis Business, IP & Strategic Support ✔ Healthcare & Pharmaceutical Feasibility Studies ✔ Business Analysis & Review Reports ✔ RFP & Proposal Writing (Regulatory & Scientific) ✔ Business Plans for Pharma & Healthcare Startups ✔ Trademark & Patent Filing Support ✔ Patent Research & WIPO Dataset Analysis for U.S. Inventors ✔ Regulatory Training & Educational Programs Why Clients Choose Me: ✅ Deep understanding of FDA regulations & global compliance frameworks ✅ Proven ability to manage complex regulatory submissions ✅ Strong blend of regulatory expertise + academic writing ✅ Detail-oriented, compliance-focused, and deadline-driven ✅ Clear communication with both technical and non-technical stakeholders I don’t just complete tasks, I protect your product, your research, and your business from regulatory risk. Industries I Serve 1- Pharmaceuticals 2- Dietary Supplements & Nutraceuticals 3- Medical Devices 4- Biotechnology 5- Healthcare Startups 6- Academic & Research Institutions Click “Send a Message” and let’s discuss how I can help you achieve FDA compliance, regulatory approval, and high-quality scientific documentation.