Reem M.

🔴Experience in ensuring compliance with: -FDA (medical devices, cosmetics, food, supplements) -TGA (medical devices) -NICNAS (cosmetics) -Health Canada (medical devices, cosmetics) -EU (cosmetics, food, medical devices) -UK (cosmetics, food, medical devices) I can create the QMS documentation in compliance with ISO 9001, ISO 45001, ISO 14001, ISO 13485, ISO 14971, ISO 22000, 21CFR820 requirements, EU MDR, UK MDR, or any other legal requirements, depending on the product and the market. Including the required Design History File, Risk Management File, and Technical Documentation. QMS ISO 13485/ QSR 21 CFR 820: I can help organizations in identifying what requirements of the Guideline applies and what kind of processes needs to be implemented. I develop processes, train teams and conduct internal Audit to ensure that your company is ready for final Audit. 🔴Experience in ensuring compliance and product registration with: -FDA -TGA -Health Canada -EUDAMED -MHRA 🔴Skilled Regulatory Affairs and Compliance Consultant specializing in food safety, labelling compliance, nutrition claims. I help food businesses navigate complex legal frameworks while ensuring product compliance. 🔴What I can do: - FDA 510 k Submission - MDR/MDD Europe - Health Canada Class l, ll, lll - Develop and Audit QMS ISO 13485 and 21 CFR 820 - Product complaint analysis - Usability Engineering guidance (IEC 62366-1) in conducting protocol reviews, study design reviews - Risk management file and risk management reviews (ISO 14971) - Labeling and IFU assessment - Product Management help for digital health and medical technologies. 🔴Also experience with: - Electrical products - Electronics - Wireless products - Machinery - General consumer products 🔴Further what I can do: - Food Labelling Compliance: Accurate ingredient listings, allergens, nutrition claims, and front-of-pack labelling. - Technical Specifications: Product specification reviews for accuracy and completeness. - Legislative Guidance: Guidance on food law, including FSA and EFSA requirements. - Project Support: Regulatory project management. 🔴Expertise in Good Manufacturing Practices (GMPs), Good Pharmacovigilance Practices (GVP), Current GMP for Canadian drugs and Natural Health Products, cosmetic regulations (Health Canada &FDA) and Good Clinical Practice (GCP)for pharmaceuticals. Applied a risk‐based approach to implementing regulations for various pharmaceuticals, cosmetics, Medical device and Natural Health Product companies, providing thoughtful justification for recommendations/decisions. 🔴 Knowledgeable about Health Canada practices and regulations for medical devices, NHPs, DINs, OTC drugs and cosmetics. Attentive and demonstrated success in handling domestic and international regulatory needs for diverse regulated product launches. Provided regulatory advice and risk assessment for business development. Managing regulatory documents from start to finish, including assessing audits, evaluating technical data and checking information accuracy. 🔴For Cosmetics: I can review your, OTC drug, Food Supplement, Food Products, and Cosmetic labels for compliance to the US FDA, EU Directives, Health Canada, and GCC countries - Cosmetic Product Classification, - Preparation of regulatory strategy for respective health authority, Labeling Compliance, Formulation Assessment for ingredients acceptability for restriction limits as per end use and end user. - Claims Assessment for acceptability and substantiation as per HA requirement. - Safety assessment for the cosmetic product. Review of Cosmetic Product Safety Report (CPSR). - Preparation of Production information file (PIF) file. - Product notification/registrations through CPNP, eCOSMA and MOCRA - FDA DIRECT portals. 🔴I also have worked with different products falling in different categories: electronics, toys, machinery, personal protective equipment (PPE), food contact materials, constructions products, childcare articles and more. So if your product falls within these categories, I can help you with it. 🔴In these categories of products, I can: • Review packaging and labelling requirements • Assistance in the creation of instructions manual • Creation of Declaration of Conformity • Compiling a Technical File • Conducting Safety Risk Assessments • Research applicable Safety Standards that are to be implemented • Defining certification strategy plan. • Manage search and contact with laboratories and certification bodies • creation of Regulatory Compliance Report • creation of Manuals ✅ Let’s connect to ensure your products meet all regulatory and legal requirements.