Hire the Best Biotechnology Regulatory Affairs Professionals

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)

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.

Certified 𝐅𝐒𝐕𝐏 Consultant & 𝐅𝐃𝐀, 𝐅𝐌𝐂𝐆 𝐂𝐨𝐦𝐩𝐥𝐢𝐚𝐧𝐜𝐞 𝐄𝐱𝐩𝐞𝐫𝐭 & 𝐋𝐚𝐛𝐞𝐥 𝐂𝐨𝐦𝐩𝐥𝐢𝐚𝐧𝐜𝐞 𝐒𝐩𝐞𝐜𝐢𝐚𝐥𝐢𝐬𝐭 with 9+ years of experience in food & FDA compliance. I'm a certified PCQI and FSVP professional from FSPCA, and Lead Auditor for BRCGS Food Safety Issue:9 & ISO FSSC 22000. Services I specialize at: - Foreign Supplier Verification Program (FSVP) | 𝐃𝐞𝐯𝐞𝐥𝐨𝐩𝐞𝐝 25+ 𝐅𝐒𝐕𝐏 𝐞𝐱𝐜𝐥𝐮𝐬𝐢𝐯𝐞𝐥𝐲 𝐨𝐧 𝐔𝐩𝐰𝐨𝐫𝐤, all with 5-star ratings. Scroll down to the jobs section to check out the amazing feedback received from clients. - Food/Supplement/Cosmetics Label Review | 50+ 𝐛𝐫𝐚𝐧𝐝𝐬 𝐥𝐚𝐛𝐞𝐥 𝐫𝐞𝐯𝐢𝐞𝐰 𝐞𝐱𝐜𝐥𝐮𝐬𝐢𝐯𝐞𝐥𝐲 𝐨𝐧 𝐔𝐩𝐰𝐨𝐫𝐤 - 𝐎𝐧𝐞 𝐬𝐭𝐨𝐩 𝐬𝐨𝐥𝐮𝐭𝐢𝐨𝐧 𝐟𝐨𝐫 𝐔.𝐒. 𝐈𝐦𝐩𝐨𝐫𝐭𝐬 (𝐅𝐒𝐕𝐏 𝐃𝐞𝐯𝐞𝐥𝐨𝐩𝐦𝐞𝐧𝐭, 𝐅𝐒𝐕𝐏 𝐀𝐠𝐞𝐧𝐭 𝐒𝐞𝐫𝐯𝐢𝐜𝐞, 𝐋𝐚𝐛𝐞𝐥 𝐑𝐞𝐯𝐢𝐞𝐰, 𝐅𝐃𝐀 𝐅𝐚𝐜𝐢𝐥𝐢𝐭𝐲 𝐑𝐞𝐠𝐢𝐬𝐭𝐫𝐚𝐭𝐢𝐨𝐧 + 𝐔.𝐒. 𝐀𝐠𝐞𝐧𝐭 𝐒𝐞𝐫𝐯𝐢𝐜𝐞) - FSVP & IOR Agent Service - FDA Domestic & Foreign Food Facility Registration + Certificate + US Agent Service - FDA LACF (Low Acid Canned Foods) Registration and SID Filing - FDA Import Alert Removal from Red List and DWPE (Detention Without Physical Examination) - FSSC 22000, ISO:22000, BRCGS & Food Safety Management System Implementation - Food Safety Plan/ Amazon Food Safety Plan Development - Cosmetic Label, Claims & Ingredient Compliance Review - Cosmetic product listing with FDA - Cosmetic Product Formulation (Organic & Vegan) - FDA MoCRA Compliance - Ecovadis & sustainability assessment services - ISO 13485:2016 & FDA QSR 21 CFR 820 - FDA, CFIA, EU, UK, FSANZ Compliant Nutritional Panels Development (including Bilingual Nutrition Panels) - Supplement Facts Development - HACCP Plan Development - Hazard Analysis & Risk Assessment - Nutrition Labeling/Food Labels/FDA Labeling - GMO's/Bioengineered Foods/Genetically Modifying Organisms - SOP’s/Policies for BRCGS, FSSC 22000, ISO:22000, QMS:9001, IFS, SQF, Halal, Kosher, Organic, Non-GMO, FDA regulations - SOP's/Documents/Audit Reports Translation (Spanish/French/German to English) - Quality Food Safety & HSE policies & Procedures - Systems certifications FSSC, BRCGS, IFS, SQF, QMS:9001 - Supplier Compliance Softwares E.G TraceGains - Food Science & Food Technologist Queries - COA's (Certificate of Analysis) - Development of Supplier Management System/Pre-Qualification Questionnaire - Corporate Social Responsibility (CSR Labor & Human Rights, Ethics, Environmental, Health & Safety, Workplace Diversity, Sustainability) Procedures/Policies Development. Standards & Certifications: BRCGS Food Safety Issue:9, FSSC 22000, ISO:22000, Ecovadis, HACCP, ISO QMS:9001, Non-GMO, Organic EU & Organic NOP, cGMP, IFS, SQF, GMP+FSA, Kosher, Halal & FDA registration. Feel free to contact for consultation services, systems implementation, FSVP/FSMA/GFSI/FDA compliance. Just a message away to offer my services. Feel free to contact for any query in detail. #FSVP #FSMA #HACCP #PCQI #LABELREVIEW #FDA #FDACOMPLIANCE #FSSC #FSSC22000 #ISO9001 #QMS9001 #BRCGS #IFS #NONGMO #ECOVADIS #FSVP #GMP #cGMP #IMPORTALERT #UPWORK #FMCG #FOOD #TRACEGAINS #NUTRITIONFACTS #NUTRITIONPANEL

I help innovative businesses and regulated organisations solve scientific and technical challenges by turning uncertainty into clear strategies, defensible documentation, and practical development plans. My background spans molecular diagnostics, biotechnology, validation, quality systems, and laboratory operations across ISO- and GMP-aligned environments. I specialise in translating complex technical work into structured documentation, scalable processes, and practical solutions that support compliance, product development, and commercial decision-making. I've spent much of my career working at the intersection of science, systems, and business. Whether supporting product development, validation strategy, technical documentation, or process improvement, my focus is always the same: helping clients make confident decisions with clear, evidence-based thinking. I work independently, ask the right questions early, and enjoy bringing structure and clarity to complex technical problems. Services include: • Scientific and technical documentation • Validation protocols, reports and evidence packages • R&D strategy and technical planning • Experimental planning and methodology • SOPs and controlled documentation • Quality systems and compliance support • Process improvement and workflow optimisation • Technical reviews and ongoing project support Documentation projects are typically quoted on a fixed-price basis according to scope and deliverables, while strategic consulting is available through hourly consultations.

I’m a Pharmacist, Regulatory Compliance Consultant & Scientific Documentation Specialist with 16+ years of experience supporting health, wellness & consumer product brands with regulatory research, compliance documentation & scientific communication. I help businesses navigate complex regulations across supplements, cosmetics, wellness products, medical devices, consumer goods & emerging healthcare categories, translating confusing regulatory requirements into clear, practical & actionable steps. Whether you’re launching a dietary supplement, reviewing cosmetic labels, assessing food contact material documentation, preparing an Amazon product listing or evaluating supplier compliance paperwork, I help ensure your products & supporting materials align with applicable regulatory expectations. My background combines pharmacy, scientific research, regulatory interpretation & technical documentation, allowing me to bridge the gap between science, compliance & business needs in a way that is accurate, strategic & easy to understand. Core Services 1. Regulatory Compliance & Product Review • Label review for dietary supplements, cosmetics, wellness products, food contact materials & consumer goods • Amazon compliance support, including CPC/CPSIA-related documentation review • Ingredient safety research & product claims assessment • Regulatory research for FDA, Health Canada, EMA, TGA, UK & international compliance frameworks • Cosmetic ingredient, packaging & labeling compliance support • Food contact material documentation review & regulatory research • Review of COAs, SDSs, test reports & supporting supplier documentation • Compliance gap analysis & risk-based documentation review • Product claims evaluation for marketing, packaging & e-commerce listings 2. Scientific & Technical Documentation • Regulatory summaries & technical documentation • SOPs, product summaries & scientific reports • Clinical & scientific literature interpretation • Evidence-based healthcare & wellness content • Medical, pharmaceutical & scientific writing • Research-backed documentation for health, wellness & consumer brands 3. Market & Product Research • Competitor & market landscape research • Product positioning & formulation trend analysis • Regulatory intelligence for global market entry • Consumer healthcare, cosmetic & supplement market research I also have experience working within highly regulated sectors including supplements, cannabinoids/CBD, pharmaceuticals, cosmetics, wellness products & emerging healthcare categories. Currently, I am expanding my expertise in product registration workflows, dossier preparation, medical device documentation support, food packaging compliance & international e-commerce compliance to better support growing global brands. Clients appreciate working with me because I combine scientific accuracy with clear communication. I understand that most founders, brand owners & e-commerce businesses are not regulatory specialists, they simply need someone dependable who can research thoroughly, communicate clearly & help them move forward with confidence. Let’s simplify compliance & build documentation that is accurate, professional & client-ready.

Clinical Research | Biotechnology | Clinical Biochemistry | Life Sciences I help healthcare organisations, biotechnology companies, pharmaceutical teams, life science startups, researchers, clinicians, investors, and innovation teams solve complex scientific, technical, and strategic challenges through rigorous research, critical analysis, and evidence-based decision-making. My experience combines advanced scientific training across three degrees in Biochemistry, including postgraduate specialisation in Clinical Biochemistry, with professional clinical laboratory practice, independent clinical research, and scientific consulting. This unique combination allows me to bridge the gap between science, healthcare, biotechnology, diagnostics, and emerging technologies, delivering evidence-based insight that supports confident strategic decision-making. I specialise in translating complex scientific information into clear, actionable insights. Alongside my professional laboratory work, I independently conceived, designed, and developed a complete clinical research study, authoring the study methodology, clinical study protocol, participant documentation, consent forms, screening documentation, and supporting research materials. This strengthened my expertise in study design, evidence synthesis, scientific writing, critical appraisal, and developing scientifically robust solutions to complex research challenges. Whether evaluating emerging technologies, conducting scientific due diligence, analysing healthcare markets, supporting clinical research, producing technical reports, or synthesising complex scientific evidence, my approach remains the same: Scientific rigour. Strategic thinking. Evidence before opinion. Areas of Expertise • Scientific & Healthcare Consulting • Clinical Biochemistry & Laboratory Medicine • Clinical Research & Study Design • Biotechnology & Life Sciences • Scientific Due Diligence • Literature Reviews & Evidence Synthesis • Scientific & Medical Writing • Healthcare Technology, Diagnostics & AI in Life Sciences • Scientific Market & Competitive Intelligence • Executive Scientific Briefings & Technical Reports I work with organisations that value analytical thinking, scientific integrity, and clear communication. My objective is not simply to deliver information, but to provide well-reasoned, evidence-based insights that support better scientific, technical, and strategic decisions.