Yamira M.

Regulatory Compliance I Quality Assurance I GxP

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!