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From nonclinical planning,
study design, placement and monitoring to regulatory document preparation of INDs and marketing applications... more » |
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provides customized scientific and strategic planning services for the safety evaluation of drug and drug-device candidates. We are experienced in regulatory interactions and can provide nonclinical representation for your program. We provide assistance in the development of nonclinical programs and design, conduct, report and file outsourced studies as well as prepare nonclinical regulatory documentation and applications from IND thru marketing.
- Comprehensive project planning/logistics
- CRO Technical assessments, contracting, QC
- Study design, protocols, placement, conduct and monitoring
- Study report review, data interpretation
- General / specialized Toxicology/Safety Pharmacology, PK
- Veterinary Specialty Services / Animal Model Development
- In-license drug candidate assessment / due diligence
- Technical writing /documentation support; IND to Marketing Authorization
- Meetings & interactions; preIND, EOPs
- Annual Report, Investigator Brochure, Waiver petitions
- Formulation Development: discovery to commercial manufacturing
- Full program regulatory support
- Quality Assurance
- Clinical program development and monitoring
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| We provide toxicology, safety pharmacology and PK support for small molecule and drug-device development with specialized
experience in dermal and ocular delivery... more » |
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