Hire the Best Drug Regulatory Affairs Professionals

I am a licensed Chemical Engineer with strong expertise in Safety Data Sheet (SDS/MSDS) authoring, translation, and Globally Harmonized System (GHS) compliance. I help companies ensure their chemical documentation meets international regulatory standards while remaining clear, accurate, and audit-ready. With hands-on experience in environmental compliance, hazardous materials management, and regulatory documentation, I specialize in delivering high-quality SDS that align with global requirements (OSHA, REACH, UN GHS, and other regional standards). What I can do for you: ✔ Author and format compliant Safety Data Sheets (SDS/MSDS) ✔ Translate SDS documents (Japanese to English and vice versa, if applicable) ✔ Classify chemicals according to GHS standards ✔ Update outdated SDS to meet latest regulatory requirements ✔ Provide hazard identification, labeling, and risk assessment ✔ Ensure compliance with environmental and safety regulations Why work with me: ✔ Strong technical background in chemical engineering and environmental systems ✔ Detail-oriented and committed to regulatory accuracy ✔ Experience in handling real-world industrial and chemical documentation ✔ Clear communication and timely delivery Whether you need a new SDS, translation of technical documents, or compliance support, I’m here to help ensure your materials meet global safety standards. Let’s work together to make your chemical documentation compliant, accurate, and reliable.

I’m Dr. Abhijath - a Top Rated Plus Freelancer with $100K+ earned on Upwork, helping pharma, biotech, medical device, and dietary supplement companies with Regulatory Affairs, FDA submissions, product formulation, and clinical/medical documentation. I specialise in Regulatory Affairs for Drugs & Medical Devices and also work as a Drug & Dietary Supplement Formulation Expert. I’m a Pharm.D with a postgraduate qualification in Regulatory Affairs and currently work as a Regulatory Lead (Contract) on U.S.-focused programs. If you’re developing a pharmaceutical, biotech, nutraceutical, dietary supplement, or medical device product, I can help you turn the science behind it into a clear, compliant, submission-ready and market-ready package. My experience across Regulatory Affairs, Clinical Research, Medical Affairs, Pharmacovigilance, and formulation science allows me to look beyond just one document. I understand how the product, clinical evidence, formulation, claims, labeling, regulatory strategy, and submission documentation need to work together. Clients typically hire me for: • U.S. FDA regulatory strategy and submission support • IND, NDA, ANDA and CTD/eCTD documentation • Pre-IND preparation and FDA correspondence • Regulatory, clinical, CMC and medical writing • Labelling of Drugs, Devices, Nutraceuticals • Protocol, Investigator’s Brochure and Informed Consent Form review • Dietary Supplement & Nutraceutical Formulation - U.S., EU & India • Ingredient selection, scientific rationale and formulation optimization • Supplement claims, labeling and technical documentation • Medical Device 510(k) regulatory support • EU MDR & IVDR documentation • Clinical Evaluation Reports (CER) and Performance Evaluation Reports (PER) • Medical Device technical documentation and regulatory gap assessment • Clinical research, ethics and IRB submission support I focus on understanding what you are trying to develop, where you want to market it, what regulators will expect, and what needs to be done to get there. You’ll get clear communication, practical recommendations, scientifically defensible documentation, and work developed with regulatory review in mind - not simply documents created to complete a checklist. Whether you are preparing an FDA or EMA submission, developing a new supplement formulation, starting a clinical program, or bringing a medical device to market, I can support you from strategy through execution. Have a regulatory or product development challenge? Send me a message and let’s discuss the best way to move your project forward. Areas of Expertise : Regulatory Affairs | FDA Compliance | FDA Regulatory Consulting | IND | NDA | ANDA | 505(b)(2) | CTD | eCTD | CMC | Regulatory Writing | Medical Writing | Clinical Research | Clinical Trial | Protocol Development | Investigator’s Brochure | Dietary Supplements | Nutraceutical Formulation | Product Formulation | Supplement Formulation | FDA Labeling | Regulatory Compliance | Medical Devices | 510(k) | EU MDR | IVDR | Clinical Evaluation Report | Performance Evaluation Report | Technical Documentation | Pharmacovigilance

I help companies navigate international regulatory compliance for food, dietary supplements, cosmetics, chemicals, and consumer products entering the US, Canadian, EU, and UK markets. ⭐ Top Rated on Upwork | 5-Star Client Feedback 🌎 500+ clients and brands supported internationally I work with startups, established brands, manufacturers, and importers to identify applicable regulatory requirements and provide practical, product-specific compliance support. 🍽️ FOOD & DIETARY SUPPLEMENTS • FDA Food Facility Registration & US Agent services • FSVP (Foreign Supplier Verification Program) • FDA Prior Notice & import compliance • Food & supplement labeling for U.S., Canada, EU & UK • Nutrition Facts, Supplement Facts, Canadian Nutrition Facts Table & EU/UK nutrition declaration review • Ingredient, formulation, allergen & claims assessment • FSMA compliance support • PCQI - Human and Animal Food 💄 COSMETICS • US. FDA cosmetic & MoCRA compliance • FDA facility registration & cosmetic product listing • Health Canada Cosmetic Notification Form (CNF) • EU CPNP & UK SCPN cosmetic notifications • Cosmetic labeling, ingredient & claims review • OTC vs. cosmetic classification assessment • CPSR compliance support • EU/UK Responsible Person requirements 🧪 CHEMICALS & CONSUMER PRODUCTS • Safety Data Sheets (SDS), OSHA & GHS compliance • Cleaning & household product compliance • California Proposition 65 (Prop 65) • U.S. & Canadian consumer product safety assessments (CPSC / CCPSA) • GCC/CPC requirements & CPSC eFiling • CE/UKCA applicability assessments • Product labeling, warnings & testing requirements FDA IMPORT DETENTIONS & ENFORCEMENT • FDA detained shipment release support • Form FDA 766 – relabeling/reconditioning applications • Corrective actions for misbranding and other compliance violations • FDA detention responses, evidence & regulatory submissions • Import Alert / DWPE removal petitions • Support with FDA communications and import compliance issues 🌎 INTERNATIONAL COMPLIANCE I support regulatory projects across the United States, Canada, European Union, and United Kingdom, including product classification, labeling, registrations and notifications, import requirements, Responsible Person/Authorized Representative requirements, CE/UKCA, WEEE/EPR, and market-entry compliance. My goal is simple: determine what applies to your product, what does not, and what needs to be done before you enter the market, helping you export with confidence while reducing the risk of detentions, penalties, compliance issues, and costly delays. If you are launching, importing, or selling a regulated product, send me your product details, target market, and what you need help with. *Regulatory services are based on the information provided, do not constitute legal advice, and do not guarantee regulatory approval.

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!

PROFESSIONAL SUMMARY With over two decades in the medical device sector, I am a seasoned Senior Medical Device Consultant offering comprehensive expertise in global marketing authorization, EU MDR compliance, and robust quality management systems. My specialization lies in ensuring medical device product compliance, spearheading both internal and external audits, implementing advanced risk management strategies, and guiding post-market procedures. My proficiency extends to the design and management of Unique Device Identifications (UDIs), and I possess a deep understanding of Software as a Medical Device (SaMD). Having hands-on experience with a spectrum of international regulatory frameworks, I am adept with guidelines from the FDA, EU MDR, MDSAP, MHRA, PMDA, JPAL, TGA, and ANVISA. My extensive knowledge also covers critical areas like distribution selection and liaison with local competent authorities. This ensures that the products not only meet global standards but also align with regional and local compliance requirements. In my consulting capacity, I've consistently been the trusted advisor to senior and executive management teams of my clientele. I provide strategic direction, clarity on compliance obligations, and navigate the ever-evolving landscape of medical device regulations. Furthermore, I offer companies' executive teams pointed direction on imperative action items and provide invaluable insights on managing relationships with distribution networks and local regulatory bodies. PROFESSIONAL SERIVCES 1. Global Marketing Authorization 2. Regulatory Compliance 3. Quality Management Systems (QMS) 4. Post-Market Surveillance (PMS) 5. UDIs Management 6. Clinical Evaluation 7. International Council for Harmonisation (ICH) 8. Medical Device Software (MDSW) & Software as a Medical Device (SaMD) 9. Data Protection Impact Assessment (DPIA) EDUCATION • BSI, AU - Management Systems Auditing, 2018 • BSI, ISO 13485:2016 Internal Auditor (TPECS), 2018 • BSI, MD - Medical Devices Quality Management Systems, 2018 • American Society for Quality, ASQ-Certified Six Sigma Green Belt, 2008 • Mohawk College, Mechanical Engineering, 2001-2004

I am a Regulatory and Quality Consultant with expansive regulatory and quality experience with medical devices, OTC drugs, supplements, cosmetic products and surface cleaners. Over the last 20 years I've held various senior and executive level management positions within FDA and EPA governed companies. I started my career as an Environmental Analytical Chemist and I held my most recent position for 9 years as QA/RA Director for a Henry Schein specialty company, Ortho Technology, a worldwide distributor of orthodontic medical devices. I would love to help you get your new product to the market, as I have experience in regulatory requirements in over 50 countries! Some of my other specialties include technical writing to include SOPs (standard operating procedures), white papers, product submissions/dossiers, Organizational SOP writing (for any type of business), Overall Quality Management Systems that comply with ISO standards and various worldwide regulatory entities. I am well versed with FDA compliant advertising and can assist you with your device and drug label development and/or editing to ensure you are compliant to your jurisdiction. All of these skills require research, so yes, I am really good at that too! My forte and favorite thing is label compliance review! I can review your device, OTC drug, supplement, food, and cosmetic labels for compliance to US FDA, EU Directives, Health Canada and more! Check out my linked in profile for links to a few of the regulatory articles I have written recently. You can also search my name on the FDA website to find 510(k) evidence and other regulatory compliant reports that I have written and submitted.