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 has a proven track record in the regulatory arena and has handled many submissions for companies globally to the FDA, Canadian, and European drug authorities. Our regulatory support services are based on providing our clients with the most efficient and cost-effective manner. The services that are offered include regulatory planning, management with full support and compliance. Some of the services that are offered but not limited to are:

  Drug establishment registrations and drug product listing
  Enforcement and compliance
  Fine chemicals and intermediates
  FDA Liaison
  Formulation Development
  GCP, GLP and GMP compliance, audits, and inspections
  IND, IDA, NDA, ANDA, BLA and NADA preparation and submission
  ISO 9000 programs and compliance
  Non-clinical program assessment, development and strategies
  Over the counter (OTC) drugs
  Package labeling and insert preparation
  Pharmaceutical Active Ingredients (PAI) issues
  Pharmacology and pharmacokinetics
  Post submission support
  Regulations interpretation
  Regulatory management and strategic planning
  Report and summary preparations
  Results assessments, interpretation and integration
  Special meeting preparation and briefing packages
  U.S. representation before FDA
  USP testing and specifications
  Validation of data


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