| Regulatory
ZURKO RESEARCH
What kind of services do we offer?
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.
List of regulatory services
for medical devices
Product Dossier
We advise our clients on the best strategy adapted to their specific needs, ensuring that organizations comply with all applicable regulations.
Quality System
Implementing, maintaining and improving the quality system in accordance with ISO 13485.
Facilities Licensing
Processing, maintaining, amending, extending and updating existing operating licenses for medical device facilities.
Other Services
Audits, contacting and requesting procedures with health authorities and notified bodies, product viability evaluation, among others.
List of regulatory services
for cosmetics
Good Manufacturing Practices
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
Product Dossier
Preparing the Cosmetic Product Information File in accordance with Regulation (EC) 1223/2009. Reviewing/adapting the PIF
Communications
Notifying the Commission before launching a product. Presenting the Declaration of Responsible Manufacturing… etc.
Other Services
Tailored regulatory assistance among others.
ZURKO RESEARCH
Customized regulatory testing
Please contact us so that we can provide you with the information you require and adapt any of our studies to your needs
