We offer a wide range of regulatory services for the Cosmetics and Medical Device sector. We advise our clients on the best strategy adapted to their specific needs, ensuring that organizations comply with all applicable regulations of each market.
We advise our clients on the best strategy adapted to their specific needs, ensuring that organizations comply with all applicable regulations.
Implementing, maintaining and improving the quality system in accordance with ISO 13485.
Processing, maintaining, amending, extending and updating existing operating licenses for medical device facilities.
Audits, contacting and requesting procedures with health authorities and notified bodies, product viability evaluation, among others.
Processing, maintaining, amending, extending and updating the existing Declaration of Responsibility for Manufacturing and Importing Cosmetic Products. Improving the Good Manufacturing Practices system in accordance with ISO 22716
Preparing the Cosmetic Product Information File in accordance with Regulation (EC) 1223/2009. Reviewing/adapting the PIF
Notifying the Commission before launching a product. Presenting the Declaration of Responsible Manufacturing… etc.
Tailored regulatory assistance among others.
Please contact us so that we can provide you with the information you require and adapt any of our studies to your needs