Medical and Chemistry/ Manufacturing
Controls expertise for Regulatory Affairs
- CTD dossiers preparation, updates and addenda for generic, hybrid, well-established use and innovator medicinal products
- CTD dossier due-diligences prior to submissions, licensing or acquisitions
- OTC dispensing status variations and disputes with Health Authorities
- Medical and CMC advisory services and MA-obtaining feasibility assessments
- Scientific discussions with Health Authorities
- Environmental Risk Assessments
Medical Affairs support
- Non-clinical and clinical research scientific support (e.g. study assumptions and protocol synopsis preparation)
- Research protocols reviews and assessment
- Clinical sites audit on behalf of sponsor, including pre-study commencing CRO suitability audits
- Medical Advisor services outsourcing: sales reps trainings, Regulatory Affairs
and Marketing departments medical support, Medical Information services
Medical services for the development of Medical Devices
- Clinical Evaluation Reports
- Biological Evaluation Reports
- Audits of biocompatibility dossier vs ISO 10993 standards series