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
  Pharmacology
  Safety pharmacology
  ADME
  Toxicology
  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