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 provides a comprehensive range of services in support of preclinical drug development of a new chemical entity (NCE) or biologic. Our team of experts work closely with our clients and each program is specifically tailored to meet the needs to support an integrated drug development program. Our specialists collaborate with internal CMC, regulatory compliance and clinical specialists to ensure that non-clinical development plans provide the most time-efficient and cost-effective strategy for our clients. We identify the most appropriate models and assays needed for the drug development, and provide a thorough appraisal of efficacy, safety, pharmacokinetics and toxicology models.

Mandava Associates offers its assessments based on its clients needs, the characteristics of the molecule and the therapy area. We then formulate a plan for the models and identify the specific studies required to characterize efficacy, safety and drug disposition properties necessary to proceed to clinical development.

The services offered are part of the overall drug development scheme or as discrete stand-alone services. Mandava Associates provides scientific and regulatory experience in both clinical and non-clinical arenas.

Our Clinical Services include:

      Clinical PK program development
      Drug metabolism studies using the in vivo/in vitro markers
      Meeting the requirements for an IND or CTA
      Product registration support
      Protein binding studies
      Serum stability assays
      Studies in man:
        Drug Interactions
        Excretion and binding
        Identification of metabolites
        P450 interactions
        Tissue distribution

Our Non-clinical Services include:
      Animal PK Modeling
      Exposure profiles in the Phase I regulatory program
      Development of an overall scheme and specific study designs
      GLP compliance audits
      cGLP Preclinical And Toxicokinetic (TK) Analyses
        Safety pharmacology
        Management of dose and bio-analysis method development and study samples
      Interactions with regulatory authorities
      Pharmacokinetics for Drug Discovery Absorption Screens
      Preparation of nonclinical pharmacology and toxicology sections for regulatory submissions such as, INDs, CTAs, NDAs and CTDs
      Preparation of regulatory submission amendments and supplements
      Profiling the metabolic fate of compounds early phase
      Review and consultation on regulatory issues affecting submissions


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