Navigating the complex regulatory landscapes governing the Industries such as cosmetics, medical device, and pharmaceutical industries requires a deep understanding of applicable legislation, standards, and guidelines. At VELISSARIOU Consultants, we are your trusted partner in ensuring regulatory compliance, helping you maintain the highest standards of quality and safety for your products.

Our team of experienced consultants possesses extensive expertise in the intricacies of regulatory compliance for these industries, including:

• CE & GMP Technical Documentation: We provide comprehensive technical documentation for your medical devices, in-vitro diagnostic products, pharmaceuticals, and combination products, ensuring compliance with applicable standards and regulations.
• Technical and Clinical Project Management: We manage the technical and clinical aspects of your products throughout their lifecycle, from development and design to clinical evaluation and regulatory approval.
• Legilsative Transition Support: We guide you through the complex process of transitioning your products to comply with the new leghislations such as Medical Device Regulation (MDR) and In-Vitro Diagnostics Regulation (IVDR), ensuring a smooth and timely transition.
• Clinical Evaluation and Protocol Issuance: We provide expert guidance on clinical evaluation, protocol issuance, and study implementation for your medical devices and pharmaceuticals, ensuring they meet the highest standards of efficacy and safety.
• Innovation, Regulatory, and Technical Support: We offer comprehensive support for design, technology transfer, and certification, including related training sessions to ensure your products meet the latest technological advancements and regulatory requirements.
• Intellectual Property Rights Management: We protect your intellectual property rights, including patents, designs, and trademarks, ensuring you maintain exclusive ownership of your innovative products and technologies.
• Supplier Evaluation and 2nd Party Auditing: We evaluate your suppliers to ensure they meet your quality and compliance standards and conduct 2nd party audits to verify their compliance, minimizing the risk of product recalls and safety issues.
• Manufacturing and Laboratory Project Management: We manage the initiation, transfer, qualification, validation, and certification of facilities, utilities, equipment, systems, processes, and products for various industries, including medical devices, pharmaceuticals, cosmetics, biocides, dietary supplements, agrifood, and raw materials.
• European Funding Support: We guide you through the process of securing European funding for innovation, helping you access valuable resources to develop and market your groundbreaking products.
• Private and International Standardization Support: We assist you in achieving private or internationally recognized standardization, enhancing the credibility and marketability of your products.
• Policy Assessment and Tender Specifications Support: We assist you in assessing policy requirements and developing tender specifications for your products, ensuring you comply with procurement regulations and meet the needs of potential customers.