Pesticides/Agricultural Chemicals
Commercial Chemicals
Food Additives and Dietary Supplements
Medical Devices
  Pharmaceutical, Biological and Biotechnology Products
      Regulatory Services
      Drug Development
      Project Management
      CMC and Compliance
      Bioanalytical and Laboratory Services
      Preclinical Assessment and Management
      Phase I Drug Development
      Phase II-IV Drug Development
     Clinical Monitoring
Veterinary Drugs

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


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