Regulatory affairs

Our specialists can help you coordinate the regulatory activities involved in registering and maintaining the product’s Marketing Authorisation (MA), as well as its access to the market, in compliance with the regulations. They can assist with implementing a regulatory strategy, supporting the life cycle of the product at every stage, including management of CMC activities, submission of clinical trials, setting up early access authorisations, advertising, validation of packaging items, etc. They are also involved in regulatory monitoring. Finally, our staff can provide support for cross-functional projects.

Our specialists can help you coordinate the regulatory activities involved in product development, in accordance with EU Cosmetic Products Regulation 1223/2009. They use their expertise to manage the regulatory compliance of raw materials, approval dossiers, cosmetic formulas, and Product Information Files. They support the design and updating of Cosmetic Product Safety Reports, as well as Cosmetic Products Notification Portal notifications. Finally, they monitor regulations and standards.

Our ISO 13485-certified specialists can help you coordinate regulatory activities throughout development, from product to market. They can also help you set up a Quality Management System (QMS) and monitor regulations and standards. You can benefit from their expertise in drawing up technical dossiers for CE marking and export registration (TGA, UKCA, 510(k), PMA, etc.). They also work alongside you to ensure post-marketing surveillance as well as interaction with notified bodies and competent authorities. Finally, they can validate promotional materials to guarantee the compliance of your medical devices.

IVIDATA Life Sciences supports you through the development, registration, and launch of healthcare innovations. Our experts guide you through all phases, from initial development to approval and market launch. Our teams of experts in pharmaceuticals and biologics support you throughout the process with CMC, regulatory, and quality advice to ensure that your products are compliant throughout their life cycle, and to anticipate local requirements.