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