Hire the Best Pharmacovigilance Professionals

I’m Dr. Abhijath Murali Pharm.D (BCMAS, RAPS-certified, PMP) - A Top Rated Plus Freelancer with 90k+ 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)

I specialize in operational support with four years of hands-on experience in the medical and tech sectors. My background as an operator has equipped me with unique insights into process optimization and efficiency enhancement. I excel at streamlining workflows, ensuring that tasks are completed accurately and on time. My experience in the healthcare field has honed my attention to detail and my ability to handle sensitive information with care. If you need someone who can contribute valuable operational expertise and help elevate your project, I am ready to collaborate. Let's discuss how I can bring my skills to your team and make a meaningful impact.

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.

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.

I’m a licensed Medical Laboratory Scientist (RMT) with a Master of Public Health and nearly 5 years of experience in clinical research, clinical data coordination, and evidence-based medical writing. My background includes working on multinational pharmaceutical clinical trials, where I handled clinical data, regulatory documentation, source documents, protocol compliance, safety reporting support, and electronic data capture systems such as Medidata Rave, REDCap, Clario, and other clinical trial portals. I specialize in translating complex medical and scientific information into clear, accurate, structured, and publication-ready content for academic, clinical, regulatory, and digital health audiences. What I Can Help You With: 🧾 Clinical Research Data Entry & Virtual Assistance • Clinical trial data entry for CRFs, eCRFs, and EDC systems • Source document review and data consistency checks • Query resolution support • Adverse event and safety report documentation assistance • IRB, ICF, SAE, delegation log, and regulatory file organization • Database cleaning and structured spreadsheet development • Literature extraction and reference tracking for reviews • Medical transcription and structured documentation formatting • Study tracking dashboards and research coordination support 🧪 Academic & Research Writing • Literature reviews and systematic reviews • Meta-analysis support, including data extraction and risk-of-bias tables • Thesis editing and manuscript refinement • Research methodology support • Journal formatting: APA, Vancouver, Harvard, AMA, Chicago, and more • Reference checking, citation cleanup, and bibliography formatting • Evidence synthesis and academic proofreading 🏥 Clinical & Healthcare Writing • Evidence-based medical articles • Clinical guideline summaries • Drug information verification • Public health reports • Clinical SOPs and training materials • Patient education materials • Regulatory documentation support • Medical content editing for accuracy, clarity, and structure 📈 Healthcare Content & SEO • SEO-optimized health blogs • Medical website content • Patient-friendly health education articles • Social media health education posts • Evidence-backed digital health content • Content that balances scientific accuracy with readability Why Clients Choose Me ✔ Licensed Medical Laboratory Scientist with clinical science training ✔ Master of Public Health background ✔ Nearly 5 years of clinical research experience ✔ Hands-on experience with multinational pharmaceutical studies ✔ Experience with Medidata Rave, REDCap, Clario, and other clinical trial systems ✔ Strong understanding of clinical data quality, protocol compliance, and documentation standards ✔ Published abstract in Sleep Medicine by Elsevier ✔ Skilled in evidence synthesis, academic writing, and medical content development ✔ Detail-oriented, organized, and reliable with clear communication I don’t produce generic medical content. I create well-researched, medically accurate, properly referenced, and professionally structured work that aligns with your project goals, target audience, and required scientific standards. Tools & Software: • Medidata Rave, REDCap, Clario, and clinical trial portals • Microsoft Office: advanced Word formatting, tracked changes, Excel spreadsheets • Google Workspace • SPSS for basic statistical analysis • Zotero, Mendeley, and EndNote familiarity • Canva for health infographics and social media visuals • Project management and collaboration platforms

If your regulatory, medical, or policy documents are unclear, weakly structured, or not aligned with FDA, EMA, or WHO expectations, they can delay decisions, create compliance risk, and weaken stakeholder confidence. When accuracy, structure, and regulatory credibility matter, you need more than a general writer; you need someone who can turn complex health and regulatory information into documents that are clear, defensible, and ready for review. ✅ 𝐀𝐛𝐨𝐮𝐭 𝐌𝐞 I am a detail-oriented and professionally grounded writer who takes documentation seriously. My approach is thoughtful, structured, and quality-focused. I believe that strong medical and regulatory writing should do more than sound professional; it should be accurate, organized, clear to the intended audience, and fit for real-world use. I value precision, consistency, and accountability in every project I take on. Whether I am drafting an SOP, reviewing a compliance-sensitive document, or preparing a policy brief, I work with care, clear communication, and respect for deadlines. My goal is always to deliver writing that helps clients move forward with confidence. ✅ 𝗪𝗵𝘆 𝗛𝗶𝗿𝗲 𝗠𝗲 ✔️ I combine medical knowledge, regulatory awareness, and technical writing discipline in one profile ✔️ I write with a strong understanding of how documents are actually used in healthcare, pharmaceutical, and public health settings ✔️ I focus on clarity, structure, consistency, and professional presentation, not just wording ✔️ I can translate highly technical material into content that is both accurate and usable for decision-makers, reviewers, and operational teams ✔️ I approach each project with a compliance-aware mindset and careful attention to documentation quality ✔️ I understand that strong regulatory and policy writing requires more than language skills; it requires logic, context, organization, and judgment ✔️ I am dependable with deadlines, responsive in communication, and committed to producing polished deliverables clients can use with confidence ✔️ I bring a practical, implementation-focused perspective that helps transform complex information into documents that support action ✅ 𝗧𝗼𝗼𝗹𝘀 𝗮𝗻𝗱 𝗧𝗲𝗰𝗵𝗻𝗼𝗹𝗼𝗴𝗶𝗲𝘀 𝗨𝘀𝗲𝗱 ✔️ Structured document drafting and review workflows with version control ✔️ Track-changes and redline-based document review processes ✔️ Regulatory and compliance review matrices for structured document assessment ✔️ Scientific and medical literature databases for evidence gathering and source validation ✔️ Reference organization and citation-management workflows ✔️ Technical formatting and style-standardization tools for consistent document presentation ✔️ Spreadsheet-based review trackers, compliance logs, and document control tables ✔️ Table, checklist, and template-based documentation systems for SOP and process writing ✔️ Structured evidence extraction frameworks for literature review and synthesis ✔️ Quality-focused proofreading and document consistency review methods ✔️ Multi-source research workflows for policy, public health, and jurisdictional analysis ✔️ Documentation frameworks for process mapping, reporting, and stakeholder-facing summaries ✅ 𝗗𝗼𝗰𝘂𝗺𝗲𝗻𝘁 𝗧𝘆𝗽𝗲𝘀 𝗮𝗻𝗱 𝗙𝗼𝗿𝗺𝗮𝘁𝘀 𝗜 𝗛𝗮𝗻𝗱𝗹𝗲 ✔️ Standard Operating Procedures (SOPs) ✔️ Clinical workflows and operational process documents ✔️ Regulatory summaries and compliance-focused reviews ✔️ Label compliance assessments and claims-review documents ✔️ Policy briefs and policy analysis documents ✔️ SBAR documents and executive briefing notes ✔️ Literature reviews and evidence synthesis reports ✔️ Technical reports and structured research documentation ✔️ Quality assurance and compliance reports ✔️ Pharmaceutical systems and supply chain assessment documents ✔️ Healthcare management and operational review reports ✔️ Clinical guidance documents and educational materials ✔️ Decision-support documents for healthcare and regulated-product teams ✔️ Structured templates, matrices, checklists, and implementation support materials ✅ 𝗞𝗲𝘆𝘄𝗼𝗿𝗱𝘀: ✔️ Medical Writing ✔️ Regulatory Writing ✔️ FDA Compliance ✔️ EMA Documentation ✔️ WHO Guidelines ✔️ SOP Development ✔️ Policy Writing ✔️ Technical Documentation ✔️ Regulatory Intelligence ✔️ Clinical Documentation ✔️ Public Health Writing ✔️ Pharmacovigilance ✔️ Label Compliance Review ✔️ Healthcare Quality Documentation ✔️ Evidence Synthesis ✅ 𝗟𝗲𝘁’𝘀 𝗖𝗼𝗻𝗻𝗲𝗰𝘁 If you need a medical & regulatory writer who can support FDA-, EMA-, and WHO-informed documentation, develop clear SOPs and policy documents, and deliver work that is both technically sound and professionally structured, I would be pleased to support your project. ✔️ Let’s connect to discuss your documentation, compliance, regulatory, or policy writing needs.