I'm a PhD-qualified biologist and data analyst with a strong foundation in biotechnology, bioinformatics, and Python-based data analysis and over 70 successfully completed projects on Upwork. My work spans scientific writing, academic research, literature reviews, data analysis and visualization using Python, and content creation for EdTech platforms. With expertise across genetics, microbiology, ecology, bioinformatics, and health sciences, I help individuals and organizations present their scientific ideas and their data with clarity, accuracy, and impact. What I Offer: *Scientific writing (research papers, review articles, literature reviews) *Grant proposals and funding applications *Educational content (MCAT, IGCSE/O/A-level biology) *Editing, proofreading, and formatting (APA, MLA, etc.) *Creative science writing for blogs or public audiences *Data interpretation and experimental design support Why Clients Work With Me: *Published in peer-reviewed journals with impact factors over 12 *Trusted by EdTech startups, researchers, and educators globally *Consistently rated 5-stars for clear communication, fast delivery, and research quality *Experience as a biology tutor with a proven “explain it your way” teaching style *Flexible with time zones and deadlines Client Feedback Highlights: • “Tahir is an extremely efficient person who works at a great pace... his turnaround time and quality of work were great.” • “A true biology professional and creative writer—thorough and insightful.” • “He follows instructions precisely and consistently delivers high-quality work.” Let’s Connect: If you're looking for someone who understands both the science and the storytelling behind impactful research and education, I’d love to hear more about your project. I’m available for both short-term and long-term work.

Medical Devices Expert / ISO 13485 / ISO 14971 / FDA / MDR / SaMD | EU MDR, FDA, SFDA, CE & Technical Files | PRRC I am a Senior Regulatory Affairs Consultant with 8+ years of hands-on experience in global medical device compliance. I specialize in guiding high-risk devices, Class III implantables, IVDs, SaMD, and combination products through EU, FDA, SFDA, UKCA, TGA, and DRAP regulatory pathways, ensuring audit-ready documentation, compliance, and timely market approvals. I provide end-to-end regulatory solutions, including device classification, technical documentation, regulatory submissions, post-market surveillance, risk management, and PRRC services. My goal is to help companies navigate complex regulations efficiently while maintaining the highest standards of safety and performance. 🌐 Global Regulatory Expertise: 🔹 EU MDR 2017/745 – CE marking, Technical Documentation, EUDAMED registration, UDI compliance, PRRC services (Article 15) 🔹 US FDA – 510(k) submissions, Quality System Regulations (21 CFR Part 820), post-market compliance 🔹 SFDA (Saudi Arabia) – Class C device submissions, PMS reporting, local regulatory compliance 🔹 UKCA / MHRA – Device registration, compliance audits 🔹 TGA (Australia) – Regulatory approvals, documentation compliance 🔹 DRAP (Pakistan) – Device registration, submissions 📌 Core Regulatory Deliverables: - Clinical Evaluation Reports (CERs) – MDR Annex XIV & MEDDEV 2.7/1 Rev.4 - Biological Evaluation Reports (BERs) – ISO 10993 series - Risk Management Files – ISO 14971:2019 - Technical Documentation – DHF, DMR, DHR, CE marking dossiers, FDA submissions - Verification & Validation Reports - Post-Market Surveillance (PMS) & PMCF Reports - Declaration of Conformity & GSPR Checklist - Labelling & Instructions for Use (IFU) 💼 Regulatory Project Experience: - Balloon stents & catheters – CER, BER, Technical File - Hypodermic needles – FDA & CE submissions - Wound management devices – PMS and technical documentation - Breast cancer detection software (SaMD) – Clinical evaluation & global regulatory strategy - IVD blood collection & DNA/RNA extraction kits – CE marking & regulatory submissions 🏆 Regulatory Experience Highlights: - Acting as PRRC, ensuring EU MDR & EUDAMED compliance for clients - Preparing, reviewing, and maintaining technical files, CERs, BERs, Risk Management Files, DHF/DMR/DHR, PMS reports - Managing global regulatory submissions across EU, FDA, SFDA, UKCA, TGA, and DRAP - Advising on device classification, intended use, borderline cases, and combination devices - Implementing and auditing Quality Management Systems in compliance with ISO 13485:2016 - Ensuring risk management and product lifecycle compliance per ISO 14971:2019 My expertise includes: • ISO 13485 Quality Management System implementation • Quality Manual preparation and documentation control • SOP (Standard Operating Procedure) development • Work Instruction creation • Form and template development • CAPA (Corrective and Preventive Action) systems • Nonconformity and deviation management • Risk Management documentation (ISO 14971) • Gap Analysis for ISO 13485 and EU MDR compliance • Internal audit preparation and audit support • Technical Documentation / Technical File preparation • Device Master Record (DMR) and Device History Record (DHR) • Change Control and Document Control systems • Supplier qualification and vendor management • Complaint handling and Post Market Surveillance (PMS) • Clinical Evaluation documentation support • Validation protocols and reports Validation Expertise: • IQ (Installation Qualification) • OQ (Operational Qualification) • PQ (Performance Qualification) • Process Validation • Equipment Validation • Cleaning Validation • Packaging Validation 🧩 Regulatory Standards & Compliance Knowledge: - ISO 13485:2016 – QMS implementation & audit readiness - ISO 14971:2019 – Risk management for medical devices - ISO 10993-1 – Biocompatibility evaluation - ISO 62366 – Usability engineering - ISO 15223-1 / ISO 20417 – Labelling & device information - IEC 60601-1 / IEC 62304 / IEC 82304-1 – Electrical & software safety - FDA 21 CFR Parts 11 & 820 – Quality system and electronic records Why Hire Me for Regulatory Affairs: ✅ Global Expertise: End-to-end RA support across EU, FDA, SFDA, UKCA, TGA, and DRAP ✅ High-Risk Device Specialist: Class III implantables, combination devices, IVDs, SaMD, borderline cases ✅ Comprehensive Documentation: CERs, BERs, Technical Files, DHF/DMR/DHR, PMS, labelling, IFU ✅ PRRC Services: Acting as your dedicated MDR compliance officer ✅ Audit-Ready & Compliant: Standards-driven, meticulous, reliable, and timely ✅ Strategic Guidance: Regulatory strategy, classification, submissions, lifecycle compliance Let’s Connect: Message me to discuss your device regulatory needs. I provide expert guidance to achieve fully compliant, market-ready, and audit-proof documentation worldwide.

I'm a toxicologist and longevity medicine research scientist with over 14 years of training and experience in biotech, consulting, government and academia. I have a proven track record in scientific study design and execution, data collection and synthesis, testing/ analytical methodologies, experimental animal research and clinical trials. I have over 18 peer-reviewed publications with more than a 1100 citations in the fields of toxicology, pharmacology and nutraceuticals. I provide toxicology risk assessments (TRA) and biocompatibility evaluations as per various regulatory standards (FDA, ISO, state guidelines such as California Proposition 65) for medical devices, pharmaceuticals, foods, supplements and consumer products. I have successfully assisted clients with obtaining FDA 510(k) clearance for their medical devices. I also provide guidance on product formulations, scientific study design (pre-clinical and clinical), data analysis and interpretation. Clear goals, deadlines and superior delivery are very important to me. Contact me to setup a zoom call to discuss how I can help you succeed.

I am a contract food scientist who helps: - Food entrepreneurs - CPG brands - Food startups with: -Labeling and regulatory compliance -New product development -Shelf life extension -Food safety

Food Engineering & CPG product development I am a highly motivated product formulator with demonstrated R&D experience in the dietary supplements industry. My skills include product formulation, regulatory review (CFR 21), project management, and process improvement in various dosage forms (powder, liquid, hard capsules, tablets). My Core Competencies are as follows: * Laboratory Techniques * Dietary supplement formulation * Organoleptic evaluation * Project management * Ingredient knowledge * FDA CFR21 labeling knowledge * Scale & batching knowledge * Process optimization * SOP development * Procurement knowledge * Global trends knowledge * Excellent communicator

As a PhD researcher with 60+ peer-reviewed publications on Google Scholar, I bring extensive expertise across medical writing, plant disease research, oncology research, and psychology-based scientific analysis. My work is rooted in evidence-based methodology, biological mechanism interpretation, and advanced academic writing standards. I specialize in developing high-quality research proposals, systematic literature reviews, and journal-ready research papers that demonstrate scientific clarity, methodological rigor, and originality. With professional mastery in academic editing, proofreading, technical formatting, and citation styles such as APA, MLA, and Harvard, I ensure every document meets publication-level precision. My coaching support for dissertations includes guidance on research design, data interpretation, manuscript structuring, and final proofreading to produce polished, defensible academic work. I have contributed extensively to interdisciplinary scientific research, producing research reports, articles, theses, dissertations, and specialized academic materials across multiple domains of life sciences. My expertise includes synthesizing complex scientific data, evaluating experimental results, and creating high-impact academic manuscripts that align with international research standards. I consistently deliver 100% plagiarism-free content verified through professional tools, ensuring authenticity and academic integrity. With strong command of Microsoft Office and advanced document structuring, I create highly professional, visually clear, and methodologically sound research outputs. I maintain flexible pricing to support diverse scholarly needs while providing unmatched accuracy, scientific depth, and professional reliability. Dr. Shamim Akhtar (PhD), Scientific Researcher

Hello... my name is Ika. Now, I am a freelance in the field of food regulatory affairs. I have experience in R&D of food industry and as a staff BPOM RI.

An Award Winning Pet Food and Pet Supplement Innovator I'm a veterinarian and formulation scientist specialized in Veterinary Nutrition with 6+ years of experience in clinical practice. I'm happy to help you with the following 1. Veterinary Nutrition - pet food/animal feed formulation - supplement formulation (including holistic) - review, enhance existing formulations - reverse engineer - pet weight loss plans - nutrition plans for healthy pets/pets with chronic disease - nutrient analysis of pet food (homemade/commercial) - endorse pet food and supplements - provide manufacturing guides - guidance on sourcing ingredients Species: dogs, cats, poultry, cattle, goat, fish, horse 2. Content writing, creation In the subject of veterinary/pet nutrition - writing i. Proof reading ii. Blog article content iii. E book, cookbook recipes iv. Endorsements v. Scientific writings on pet food/animal feed/supplements vi. white paper writing/copy for supplements and food/feed vii. digital products for veterinarians and pet owners for personal use, resell or publish My portfolio represents samples of my previous work My submissions are timely and focused Drop me a message with your requirement before sending me your offer

Most mental health and self development content says the right things and means none of them. Safe, smooth, forgotten the moment the tab closes. I write for practitioners, researchers, founders, and coaches in the consciousness space who have something real to say and need someone who can say it with them for a modern audience. I've also lived the material. Burnout, complex trauma, the long non-liner process of rebuilding from the inside out. I'm not translating this world from the outside, but rather from lived experience. If you have work that matters and you need someone who can meet you at the level of your ideas, I'm that person.

As a food technologist, i have experience in writing food product specifications and also checking artwork from the nutrition to the allergens to ensure it is legally complaint with the EU law. I have experience in managing projects, evidenced by writing several food product specifications following it from concept to launch and ensured all stages were perfect in order to meet the launch deadline. My organisation skills and attention to detail will be of great advantage to any project.