Hire the Best Biotechnology Regulatory Affairs Freelancers
in India

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 a pharmacy graduate with hands-on experience in FDA regulatory work. I help businesses like yours get their products registered and compliant for the U.S. market. Whether you're launching something new or managing ongoing submissions, I can take care of the technical details so you can focus on growth. Services I Offer: ✅ Amazon Product Listing & Reinstatement Support ✅ Human & Animal Drug Listing (NDC Code) ✅ OTC & Cosmetic Product Registration ✅ Dietary Supplement Submission & Label Review ✅ Facility Registration via FURLS / CDER Direct ✅ SPL/XML File Creation & ESG Account Setup ✅ Animal Feed & Veterinary Product Listing ✅ U.S. Import/Export Documentation & Compliance ✅ DUNS Number Registration & Address Updates ✅ Label & Artwork Review, Editing, and Finalization I understand how confusing and time-consuming FDA processes can be. I’m here to make it easier, faster, and stress-free — with clear communication and accurate, timely work. Let’s get your product FDA-ready!

An accomplished Regulatory, Quality, and Clinical Affairs professional with over 16 years of experience in developing and executing regulatory strategies to ensure compliance with global regulatory requirements. Demonstrated expertise in leading cross-functional and multidisciplinary teams, building and sustaining strong relationships with key stakeholders, and translating complex regulatory and clinical information into clear, concise, and actionable communications. Possesses broad, hands-on experience across regulatory affairs, quality assurance, clinical trials, labelling, and real-world evidence, complemented by strong project management capabilities. Proven ability to work both independently and collaboratively within multicultural and cross-functional organisations. A subject-matter expert in medical and regulatory writing, with extensive experience in preparing and reviewing CEPs, CERs, PMS Plans and Reports (PMSP/PMSR), PMCF Plans and Reports, PSURs, BEPs, BERs, and SSCPs in compliance with EU MDR requirements. Highly experienced in drafting clinical study protocols, protocol amendments, and clinical study reports. Brings a deep understanding of international regulatory frameworks, requirements, and systems that enable successful product development, market access, and the generation of new research opportunities and revenue streams.

Bioscience researcher with more than 20 years of R & D experience in proteomics and cell based therapeutics. Hold a masters in Biotechnology and Ph.D. in Biochemistry. Key research areas include protein / antibody purification and characterisation, antibody labelling, design and development of biomarkers and cell-based assays for equine application. Strong foundation in bio-analytical method validation, especially on biomarkers relevant to inflammation, oxidative stress, regeneration and bone-metabolism. Established novel macrophage therapy for treatment of musculo-skeletal injuries in racehorses, actively involved in R & D of equine regenerative therapies which include Orthokine, Mesenchymal stem cell (MSC) therapy and platelet rich plasma (PRP) therapy. Developed a panel of cell based assays using High content imaging platform, to monitor the innate and adaptive immune function. These assays shed a new perspective on performance development in elite race horses and were extended to monitor fertility and reproductive performance. Established the pipeline for recombinant equine therapeutic protein production using mammalian cell culture. Developed and optimised upstream and downstream protein production using HEK-293 cells, that could be scaled up to a 20 L capacity. Established recombinant protein purification using AKTA systems and supported the equine clinical trials for testing the efficacy of the purified protein. Developed and patented novel skin care formulations based on in-depth research, lab experiments and cell based assays to assess the action mechanism of topical drugs on immune cells. Important products developed include HoofCream (patented, EP3305288 AI), moringa cream, henna cream, amnion cream, dermatitis cream, autologous serum based creams for dermal wound healing. Ability to combine research and creativity, provide virtual technical support on material and device sourcing, prototype development, scale up, QC development and stability testing of topical formulations. Proactively scans new research concepts, materials and technical opportunities. Ability to select and blend functional ingredients for specific product requirements. A self-motivated scientific writer and editor with a positive attitude, excellent organisational skills and loves varied assignments. Extensive experience in systematic literature analysis to support evidence-based decision making process. Ability to critically appraise evidence, interpret complex scientific data, detect shortcomings, recognise opportunities and develop knowledge and insights to support evidence based answers. Experience in systematic literature analysis and meta-analysis using R for clinical evidence, ensure that the work is scientifically accurate and fully referenced. Broad knowledge of medical and scientific topics with experience in comparing laboratory devices, diagnostic kits, analytical methods, assay validation and is confident to work on these areas Team player with strong work ethic and commitment to deliver quality work on time. Passionate about lifelong learning and self-improvement.

I am a M.Sc. graduate in Biosciences with nearly 3 years of research experience in internationally renowned laboratories, including the Centre for Cellular and Molecular Biology (CCMB), Hyderabad, and the University of Hong Kong. My core expertise spans molecular biology, structural biology, DNA damage response, and chromatin regulation. Over the years, I have worked hands-on with protein purification, Cryo-EM sample preparation, molecular cloning, transcriptomics analysis, and fluorescence imaging, and I have contributed to research focused on gene regulation and DNA-protein interactions. I also have experience in preparing publication-ready figures, scientific writing, and literature reviews. I am currently offering Literature review services, Protocol design, troubleshooting, scientific editing, and data interpretation at a starting hourly rate of $20 per hour to build long-term collaborations and demonstrate the quality of my work. Whether you're a PhD student, academic researcher, or startup founder, I can assist with: Editing manuscripts and research proposals Creating clean, accurate biology figures and slides Reviewing literature or summarizing recent findings Troubleshooting experimental protocols or optimizing assays Assisting with ATS-friendly CV and SOP for PhD Application 💼 Additional Skills: 📝 Resume & Cover Letter: My passion for precision extends to the art of resume and cover letter creation. I specialize in curating documents that not only showcase professional achievements but also captivate employers. Let me help you stand out in a competitive job market and land the opportunities you deserve. ⌨️ Typing Excellence: With a keen eye for detail, I excel in accurate and timely typing. Whether it's data entry, transcription, or any other typing task, I ensure the highest quality output. 🌐 Why Choose Me? I am excited about the prospect of working with multiple clients on Upwork to broaden my skill set further. I bring a unique combination of technical expertise, writing finesse, and a commitment to delivering quality results. Let's collaborate to elevate your projects and achieve success together! Let's embark on a journey of scientific exploration and professional advancement. Reach out, and let's discuss how I can contribute to your project or help you present your best self through compelling resumes and cover letters.

With 9 years of experience in the industry, I am a seasoned QARA professional specializing in quality management systems and regulatory compliance. Here is a brief overview of my proficiency and background. - Specialization in ISO 13485 and 21 CFR-compliant Quality Management Systems for medical device manufacturers. I have set up the QMS for 7 medical device manufacturers to date. - Regulatory Markets: Support regulatory compliance across India, the US, the UK, and European market. Plan and support 510(K) approvals. - MDR 2017/745 services for CE certification: Provided MDR services such as clinical evaluation and post-market surveillance for over 36 medical devices. - Audit Excellence: Certified internal auditor, adept at comprehensive audits for continuous improvement. -Hands-on experience with project management: I have successfully led a team of 30 individuals through the intricacies of a product development program (Software+Hardware). Some of the International clients I have worked with are; CIRCA Scientific MC3 Corp Varex Imaging Asensus Surgical Channel Medsystems Morair Medtech Micrima Limited Better Medicine NeuroMagnetics Australia Acme Medical AxioMed LESspine Hyfe Inc.