Pesticides/Agricultural Chemicals
Commercial Chemicals
Food Additives and Dietary Supplements
Medical Devices
Pharmaceutical, Biological and Biotechnology Products
Veterinary Drugs

Mandava Associates provides assistance to small, medium, and large companies in dealing with FDA in accordance with the FDA guidelines for medical devices. Some of the services covered under this section include:

    FDA Medical Devices
      Analytical Chemistry
      Clinical trials management
      Compliance and enforcement
      Data development and evaluations
      Device establishment registrations and product listings
      Device master files
      GMP and GLP compliance, audits, and inspections
      Investigational device exemptions
      ISO 9000 programs and EN 46000 standards
      Medical device reporting and adverse effects
      Labeling and advertising
      Premarket notification-510(k)
      Premarket approvals (PMA)
      Regulatory strategic planning and device design
      Toxicology and safety assessments
      U.S. representation before FDA
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