Scientists providing logical solutions
Specialist support for pharmaceutical companies
Many years of experience and a team of experts
Services
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
- Preparation and updates of Product Information texts
- CTD dossier due-diligences prior to submissions, licensing or acquisitions
- OTC dispensing status variations and disputes with Health Authorities
- Medical and CMC advisory services, scientific litearture reviews and MA-obtaining feasibility assessments
- Scientific discussions with Health Authorities
- Environmental Risk Assessments, Phase II assessments inclusively; with reference to scientific literature and in silico QSAR modeling
Medical Affairs support
- Non-clinical and clinical research scientific support (e.g. study assumptions/synopses and study protocols preparation)
- In silico toxicological analyses - QSAR modeling
- Paediatric Investigation Plans scientific parts and Key Elements Form preparation, Scientific Advice briefing books preparation
- Medical Advisor services outsourcing:
- sales reps trainings
- Regulatory Affairs and Marketing departments medical support
- Medical Information services
Medical services in the medical device lifecycle
- Scientific Support in Clinical Studies and PMCFs planning, survey studies inclusively (studies synopses and protocols preparation)
- Support in Instructions For Use (IFU) drafting, verification and updates
- Clinical Evaluation Reports (CERs) preparation and updates
- Biological Evaluation Reports (BERs) preparation and updates
- Scientific literature reviews supporting materiovigilance activities
- Audits of biocompatibility dossier vs ISO 10993 standards series
