Mandava Associates works with both pharmaceutical and biotechnology companies to identify goals and then design and implement drug development programs to achieve those outcomes. Mandava Associates is expanding from its core offerings of regulatory consultations to include drug development consultation and clinical development operations. These new services will offer pharmaceutical and biotechnology clients a broad range of drug development services from initial drug discovery of a lead molecule to final FDA approval. Data is reviewed on a real time basis as it is generated to identify emerging issues and with the ability to place a special emphasis on pharmacovigilence and safety data.
Mandava Associates provides these expanding services through our experienced personnel from both the government and/or industry in providing the optimum results for drug development strategy and project management. The projects are implemented through our various associates who would be most qualified to handle each specific project.
Some of the services that we offer include, but are not limited to:
Comprehensive drug development programs, including:
Clinical trial conduct
Develop/Assist in the development of clinical protocols
Develop/Assist with development of data capture forms and reviews of SOPs
Obtain FDA concurrent on protocols/SOPs
Individual components of development such as clinical and regulatory services.
Projects covering CMC, GCP, GLP, GMP, pre-clinical, clinical and comprehensive regulatory services.
Various Phases (Phase I, II, III or post-approval) of drug development
Portions of drug development such as pre-IND, portions of clinical trials, NDA
Global development through our alliances in U.S.A, Asia-Pacific rim and Europe
Strategic and full regulatory review through direct interaction with the FDA.
An expert advisory board made up of highly qualified specialists in their fields.
Project management with full monitoring support.
Real time data analysis with the ablility to assess data trends