Across product categories
Regulatory Documentation and Compliance
Practical help with the consistency, completeness and continuing maintenance of regulatory documentation.
What we help with
- Document assessment and gap analysis before an application.
- Manufacturer and brand-owner coordination for supporting evidence.
- Application preparation and responses to authority queries.
- Label and claims review against the applicable requirements and evidence.
- Renewals, amendments and continuing compliance within the agreed engagement.
Who this is for
Manufacturers, importers, brand owners and regulatory partners working with medical devices, cosmetics and borderline products. The work depends on your product and your responsibilities in the supply chain.
How the work is organised
We first identify the product, intended use and applicable route, then review the documents you already hold. We agree the scope, identify who must provide missing evidence and prepare the relevant corrections or application materials. Regulatory decisions remain with the authority.
Start with a brief overview
For your first enquiry, describe the product, manufacturing country, current registration position and the documentation issue you need help with. A secure method for confidential documents can be agreed separately.
Read the Medical Devices, Cosmetics or Borderline Products page for category-specific context.
Contact RAQ
Discuss a regulatory project
Tell us about the product, your role and where it is made. We will suggest which service applies and a suitable next step.
Please do not send formulations, confidential dossiers or other proprietary information in a first message.