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 and successful track record in Pharmaceutical, Biological and Biotechnology product development. Some of the services that are covered under this area but not limited to are:

    FDA Pharmaceuticals and Biologics
      Absorption, distribution, metabolism and excretion (ADME)
      Analytical chemistry
      Bioequivalence issues
      Certification of Suitability (COS) to European Pharmacopoeia
      Chemistry, manufacturing and controls (CMC)
      Clinical Monitoring
      Conduct of Phase I IV clinical trials
      Data development and strategy
      Data management and QA
      Drug delivery systems
      Drug development strategies and assessments
      Drug Master Files for US, Canada and EU
      Drug establishment registrations and drug product listing
      Enforcement and compliance issues
      Environmental assessments and impact statements
      Fine chemicals and intermediates
      FDA Liaison
      Formulation Development
      GCP, GLP and GMP compliance and audits
      IND, IDA, NDA, ANDA, BLA and NADA preparation and submission
      ISO 9000 and ISO 14000 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
      Pharmacodynamics and pharmacokinetics
      Post submission support
      Preparation for site audit
      Product design and development
      Protocol development
      Quality assurance and quality control
      Regulations interpretation
      Regulatory management and strategic planning
      Safety reporting
      Special meeting preparation and briefing packages
      Study report and summary preparations
      Toxicology, pathology, microbiology and safety assessments
      U.S. representation before FDA
      USP testing and specifications
      Validation of data

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