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. Creating Material Safety Data Sheets (MSDS), 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