- Evidence-based intelligence reports on both biopharmaceuticals and
conventional pharmaceuticals - Systematic Reviews
- Meta-analyses
- Pharmacoeconomic assessments
- Estimation of market potential of new drugs
- Expert reports for drug regulatory submissions
- Medical affairs consulting
- Clinical expert reports and PSURs
- Clinical study reports/medical writing/publications
- Drug safety evaluations
- Evaluation of advertising and promotion from the standpoint of
compliance with applicable agency rulings and policies - Advice and assistance on preparation, submission and monitoring of
applications for over the counter (OTC) drug switches - Regulatory Counsel with regard to all national and EU relevant
regulations and provisions. - Advice and assistance in the preparation, submission and monitoring of
applications, re-registrations, renewals, variations, petitions and advisory
opinions - Update of existing registration documentation ( e.g. rewriting to CTD-
format) - Arrange and conduct meetings with regulatory agency officials
Training and educational activities
- Drug-related training packages for medical, pharmacy and
pharmaceutical marketing personnel Training Packages - Advanced level seminars on pharmaceutical licensing and drug
development
 |
| |
 |
| |
 |
| |
 |
| |
 |
| |
 |
| |
 |
| |
 |
| |
 |
| |
 |