What services do we offer?

Below is a sample of the projects Sharp Regulatory can undertake, please contact us to discuss your specific requirements: [email protected]

We can price our work as time and materials or as a fixed cost depending on the nature of the work required and client preferences.

Regulatory Strategy
Regulatory Intelligence
Regulatory Project Management
Gap Analysis / Scientific Data Assessment
Product Development Plans
Health Authority and Notified Body Meetings
Document Authoring and Review / Responses to Agencies / Marketing Authorisation Procedures
Paediatric Plans
Orphan Drug Submissions / Designation
Medical Device Classification / Dossiers
Training
Ad-hoc Consulting