Drug and medical device submission
Regulatory issues are a permanent concern in clinical research for your submission of a new compound or device to be accepted, you need to present error-free, quality-controlled regulatory documents. Our highly- qualified regulatory team prepares, coordinates and manages all the activities associated with clinical trial submissions for companies throughout Europe.
Our services cover:
- Medical writing of:
- protocols
- investigational brochures and annual updates
- clinical study reports
- informed consent forms
- benefit-risk assessments reports
- Clinical development plans
- Medical and scientific literature reviews
- Clinical sections of Common Technical Documents (CTDs)
- Pharmacovigilance documents
- Preclinical study reports, expert reports and summaries
- Data safety monitoring boards
- Written and tabular summaries
- Completion of CTA forms and/or ethic committee forms
- Discussion and meetings with competent local authorities