Pre-Clinical and Clinical Development
We offer the following development services:
- Formulating pharmaceutical product development programs and plans
- Legal strategies and patent development
- Clinical protocol development and study designs for phases I through IV
- BA and BE clinical approaches and protocol development
- PK / PD modeling and simulation
- Medical writing
- Biostatistical and statistical approaches
- Formulation and process evaluation
- Small molecule synthesis to macromolecule bio-processing
- Solutions, solids, suspensions, aerosols, transdermals, parenterals
- Analytical / Bioanalytical approaches
- Validation plans
- Quality systems
- IND preparation and submission
- Package insert preparation
Organization and preparations for FDA – Sponsor Meetings including:
- Pre-IND Meetings
- End of Phase II Meetings
- Pre-NDA Meetings
- Other type A, B, and C meetings, regulatory submissions and responses
- Construction of Standard Operating Procedures (SOPs) for product development and clinical research
- Review business practices, opportunities and products for licensing, development, and due diligence prior to acquisition or public offering