Hire the Best Drug Regulatory Affairs Professionals

Welcome! I am Yamira Munkel, a seasoned Regulatory and Quality Expert with over a decade of experience in the pharmaceutical industry. With GxP-Background. Certified PRRC (EU MDR 2017/745 / EU IVDR 2017/746, Responsible Person (GDP Directive 2001/83/EC), Responsible Person (Cosmetics EU Cosmetics Regulation 1223/2009). I am passionate about guiding businesses through complex pharmaceutical regulatory requirements. My expertise includes technical writing, such as Standard Operating Procedures (SOPs), and in-depth knowledge of Quality Management Systems (QMS) that comply with ISO standards and global regulatory frameworks. Furthermore, my experience encompasses EudraLex Volume 4, ensuring that pharmaceutical products adhere to jurisdictional compliance standards. I also possess extensive expertise in GDPR, Computer System Validation (CSV), lead auditing, CE certification, and ISO 9001 and ISO 13485 compliance. Research, technical documentation, and regulatory submissions are among my core competencies. If you require regulatory affairs expertise, quality management system guidance, or support with regulatory submissions in the pharmaceutical industry, I am here to assist. My vast experience in regulatory and quality affairs ensures that your products meet international standards and compliance requirements. Let’s collaborate to bring your pharmaceutical products to market with confidence and compliance! I look forward to connecting with you!

I’m Dr. Abhijath Murali Pharm.D (BCMAS, RAPS-certified, PMP) - A Top Rated Plus Freelancer with 100k+ earnings from Upwork with cross-functional experience at IQVIA, Cipla, IPCA, and Accenture. Past Experience : - I am having 8+ years of combined experience in Regulatory Affairs + Clinical Research + Medical Affairs - guiding sponsors from first-in-human to post-market. - I help in formulation of Dietary Supplements in US, EU, India. - I help biotech and pharma teams design inspection-ready studies, secure ethics approvals, and deliver submissions that move programs forward on time and audit-proof. - MDR/IVDR support, Clinical Evaluation Reports, Performance Evaluation Reports, and technical file documentation. - I perform Regulatory gap assessments, audit readiness, health authority response support, and compliance strategy. Expertise on : USFDA • EMA • CDSCO I support IND/CTA/NDA submissions, eCTD documentation, labeling compliance, QA workflows, and clinical writing across startups, CROs, and emerging biotech teams. My focus is delivering accurate, inspection‑ready documents that accelerate development timelines without compromising compliance. What I Deliver : - IND, CTA, NDA, and ANDA module writing, particularly for CTD Modules 2 to 5. - Submission Preparation : eCTD support (Modules 1–5) - Labelling : US Prescribing Information, SmPC, CCDS review, labeling compliance, and content alignment. - SOP development, QA documentation, CAPA logs - Regulatory Writing : Clinical writing: Protocols, IBs, CSRs, safety summaries - Regulatory intelligence & documentation QC - Variation Preparation & Renewal Analysis (US & EU) Why Clients Work With Me : - RAC (US,EU, Global) certified - Strong foundation in FDA, EMA, HC, and ICH frameworks - High accuracy, fast turnaround, and structured workflows - Experience validating regulatory datasets used in AI systems - Ability to produce submission‑ready content across drugs, biologics, and devices If you need support preparing a submission, reviewing labeling, drafting SOPs, or QC‑checking regulatory documents, I can step in immediately and deliver with precision. Send me a message with your project details - I typically respond within a few hours. Also, If your regulatory documentation needs to be ready for submission and not sent back for repeated revision, share your project brief. I can help turn complex regulatory content into a strong, well-structured submission package. Keywords : Regulatory Affairs • IND/IDE • 510(k) • SaMD • ICH-GCP • IRB • Clinical Trial Design • Protocol Development • Pharmacovigilance • Medical Writing • CSR • IB • EDC/CRF • EMA • CDSCO • US FDA • 505 b(1) • 505 b(2)

As a Regulatory Compliance Consultant and Head of Regulatory Compliance, I help international brands and manufacturers launch and scale their products not only in the United States, but also in Europe, the United Kingdom, Canada, and Latin America, ensuring full compliance with the regulatory framework of each region. My expertise covers the main global regulatory agencies for food, dietary supplements, cosmetics, textiles, medical devices, electronics, and various consumer products. My services include: - UNITED STATES - (FDA, USDA, EPA, FCC, CPSC, CBP, FWS): ✅ FDA Facility Registration: Food, dietary supplements, cosmetics, OTC-adjacent products, and pet food facilities. Foreign + domestic registrations, renewals, product listings, and U.S. compliance adaptation. ✅ US Agent Services: Acting as your official U.S. Agent to represent your company before FDA and U.S. authorities. ✅ FSVP Agent Services: Foreign Supplier Verification Program development for food and supplement importers. ✅ EPA Registration: Pesticides, disinfectants, industrial/automotive chemicals. ✅ FCC Certification: Wireless products, Bluetooth devices, smart electronics. ✅ USDA Licensing & Inspection Support: Animal-based, agricultural, and honey/propolis products. ✅ FWS Import Permits (CITES): Exotic leathers, wildlife-derived materials, hunting trophies. ✅ CPSC Compliance: Children’s products, toys, textiles, law labels, safety testing requirements. ✅ CBP Customs Compliance: HTS classification, import documentation, Prior Notice, and customs support. - EU & UK Compliance: I support companies entering the European Union and UK markets, including: ✅ EU Responsible Person (RP) Guidance & Setup: Cosmetics, supplements, electronics, textiles, and various consumer products. ✅ EU/UK Labeling Compliance: Adaptation for multilingual labeling (EN/FR/DE/ES/IT), technical file requirements, claims, allergens, nutrition panels, textile labeling and fiber composition. ✅ Product Compliance & Registration: – EU Food & Supplement rules (EFSA) – Cosmetic Product Notification Portal (CPNP) – UK SCPN Notification – CE/UKCA pathways – Textile & apparel compliance (fiber rules, care labels, REACH) ✅ Documentation & Market Access: GMP expectations, safety assessments, product information files (PIF), and import documentation. - LATIN AMERICA (Brazil, Mexico, Chile, Colombia): Support for brands expanding across Latin America: ✅ Brazil (MAPA / ANVISA guidance): Food, supplements, cosmetics, packaged foods. ✅ Mexico (COFEPRIS / RFC Importer Registration): Food, cosmetics, dietary supplements, OTC-adjacent products. ✅ Regional Labeling Compliance: Adaptation for Spanish/Portuguese labeling, mandatory warnings, nutritional tables, allergen formats. - GLOBAL SERVICES: Regardless of your target market: 🎯 Labeling Compliance & Regulatory Adaptation FDA + EU + UK + LATAM-compliant labels, packaging, claims, and disclosures. 📄 Safety Data Sheets (SDS) SDS preparation following OSHA HazCom 2012 / GHS. 🧩 HTS Classification & Market Feasibility Identifying regulatory requirements before exporting. Working Policy: All regulatory reports include a 10-business-day clarification window from the date of delivery. After this period, any additional review, follow-up, or new questions will be handled as a separate consulting engagement. Work begins only after all requested product information and documentation have been fully and accurately provided by the client. Final responsibility for verifying technical product data (including ingredient quantities, specifications, claims, and label details) remains with the client prior to commercialization.

Hi, I’m Ido. I am a medical fact checker and scientific reviewer with a background that bridges high standard laboratory science and holistic wellness. If you publish content in the health, supplement, or biotech space, I am here to ensure your articles and product descriptions are scientifically accurate, authoritative, and aligned with regulatory standards. Unlike general editors, my work is backed by real world laboratory and clinical experience: • Laboratory Leadership: I previously served as Head of the HPLC Department at a genetic biotech startup and as a Lab Team Lead for molecular testing. This gave me a deep, hands on understanding of chemical analysis, quality control, and strict compliance. • My B.Sc. in Marine Biology (graduated with honors) provided me with a strong foundation in core biological sciences, genetics, and biochemistry, which are fully transferable to any scientific field. Investigating complex marine ecosystems sharpened my ability to analyze intricate biological data, evaluate peer-reviewed research, and maintain a strict scientific approach to fact checking. • As a certified Shiatsu therapist and advanced student of Traditional Chinese Medicine, my daily clinical practice keeps me deeply connected to real world patient care. To provide the best integrative treatments, I constantly review the latest biomedical literature and clinical trials regarding botanical synergy, supplement safety, and bioavailability. How I can help your team: •. Fact-Checking: I audit your existing content against peer-reviewed studies (PubMed/NCBI) to verify clinical and health claims. • Compliance Review: I screen for high-risk language and disease claims to help keep your copy safe and aligned with FDA guidelines. • E-E-A-T Optimization: I refine health content so it meets the high standards of expertise and trustworthiness that readers and search engines look for. I prefer to serve as a reliable, long-term scientific gatekeeper for a select few brands rather than rush through quick edits. If you need someone to review your upcoming articles or product lines, feel free to send me a message, and I will get back to you as soon as possible.

As a PhD biochemist with over 40 years of experience in the biotechnology and pharmaceutical industries, I offer comprehensive consulting services in biotech project management, regulatory affairs, and process development. My expertise spans: Leading complex pharmaceutical projects as Projects Director at Biotechnology General for 14+ years Managing regulatory affairs (RA) for multiple biotech companies including Omrix Biopharmaceuticals and InterPharm Laboratories Developing and validating biotechnology processes at Kamada Ltd Evaluating innovative biotech projects at the Israel Innovation Authority I excel at bridging the gap between research and implementation, having worked across the entire pharmaceutical development pipeline - from basic research to regulatory compliance. I'm particularly skilled in: Project portfolio management Regulatory compliance and validation Process development and optimization Technical evaluation of biotech innovations I'm fluent in English , enabling me to work with international teams and documentation. As your consultant, I can help with regulatory strategy, process optimization, or project evaluation needs in the biotech/pharma space. I pride myself on delivering thorough, scientifically-sound solutions while maintaining compliance with industry regulations.

Since 2019, I’ve worked across the pharmaceutical and medical communications space supporting brands with project management, Veeva uploads, tagging and linking, KOL coordination, content development, and financial/operational tasks. I help teams stay organized, compliant, and ahead of deadlines. What I Can Help You With: Project Management: vendor coordination, status tracking, and workflow optimization Veeva (PromoMats/MedComms): uploading, tagging, referencing, linking, routing, and ensuring documents meet compliance standards KOL & Speaker Management: outreach, scheduling, prep materials, logistics, and follow-up Medical/Promotional Copywriting: slide decks, speaker notes, emails, meeting summaries, branded/non-branded content Financial Support: budgeting, invoicing, reconciliations, PO tracking General Ops Support: meeting planning, content tracking, asset organization, and process improvement Why Clients Like Working With Me: ✔ 6+ years in pharma/biotech marketing and medical communications ✔ Strong understanding of compliance, MLR workflows, and brand strategy ✔ Fast, detail-oriented, collaborative, and comfortable jumping in mid-project ✔ Ability to take on both strategic and executional tasks If you need someone reliable who understands the nuances of pharma, MLR, and KOL engagement, I’d love to support your project.