|
|
|
SERVICES OVERVIEW
This is a general list of the types of services Intrinsik Health Sciences provides
to our clients. Should you require additional information please do
not hesitate to contact us.
- Interaction with regulatory authorities on behalf of clients
- Product development and registration strategies
- Data reviews and gap analyses
- Pre-IND/CTA, IND/CTA, NDA/NDA/MAA text preparation and review
- Toxicology consulting including providing expert opinions and
strategic advice on preclinical and regulatory issues
- GLP support (inspections, study monitoring, and SOP review and
preparation)
- Selection of appropriate laboratories (cost benefit analyses
and focussed insight into strengths and weaknesses of vendor options)
- Developing and reviewing toxicology protocols, study designs,
and draft reports
- Impurity assessment and qualification
- Investment due diligence- (In-licensing, scientific due diligence,
and technical support
|
