OPIS Pre-Clinical Consultancy
Since OPIS enterprise started off, an impressive amount of effort and dedication has been poured into the great vision of this reality, in order to achieve the current assessment, unrelenting attention has been paid to specific training and tutoring programs, so that competences and expertise could be widely shared by all its members. Transparency, reliability and loyalty are known to be the pillars of this company, a community, indeed, aimed at carrying out exclusively excellent operational capabilities.
The successful transition from pre-clinical into clinical phase is determined by a wise combination of scientific, technical and legal skills, implemented into well-defined timelines thanks to accurate execution strategies.
Customers are provided with cutting-edge sound scientific advice, top-notch medical and methodological considerations and permanent assistance throughout the regulatory and/or pharmacological phases.
The following services are offered in relation to pre-clinical to clinical drug development:
- Review of pre-clinical research strategies.
- Input on non-clinical pharmacodynamics, toxicology, toxicokinetics, pathology, drug metabolism and pharmacokinetics.
- Contact international tox CROs, review of protocols and study reports.
- Quality assurance/GLP.
- QA audits.
- Pharmaceutical development/CMC.
- Regulatory: IB preparation, Briefing Documents for scientific advice and FDA meetings.
- Preparation of CDT for New Drug Application (NDA).
- Feasibility and trial design.
- IMPD writing.
- Meeting with Regulatory Authority: FDA pre-IND, EOP2, pre-submission, special protocol approval procedures; EMA Scientific Advice; National Authorities Scientific Advice.
Throughout these years, OPIS has proved itself efficient in ensuring strategic and correct pre-clinical data to be compliant with the regulatory process prior to the roll-out of the subsequent clinical phases.
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