Consultancy

QbD Consultancy

  • Personal visit, Training and Inducting the whole team on the complete process
  • QbD Development Support throughout - from initial R&D to launch and beyond
  • Support and Optimize the R&D - to manufacturing interface

IVIVC Consultancy

  • Dissolution and IVIVC evaluation to support pharmaceutical dosage form development
  • Help and Train formulation scientists in the subject and to achieve IVIVC
  • Assist in Regulatory Submission Biowaiver requests

PK-PD Consultancy

  • Pharmacokinetics and Pharmacodynamics (PKPD) support to preclinical, clinical research and development as well as Post Marketing product Life Cycle management
  • Bioequivalence evaluation as per the regulatory requirements (FDA/EMA) needed during drug development as well as evaluation of generic products to submit Abbreviated New Drug Applications (ANDAs)
  • Strategic planning for programs (discovery through life cycle management)
  • BA, BE, Clinical pharmacology study designs
  • Identify CROs for study conduct and bio-analysis
  • Nonclinical Pharmacokinetic and Drug Metabolism Evaluation
  • Clinical Study Report Writing, preparation of documents for Regulatory Submissions

Regulatory Consultancy

  • Extensive regulatory related services including issue based consultancy
  • Represent companies for any issues in USFDA
  • Review Regulatory Submission documents before submitting to USFDA
  • Biowaiver Request
  • Preparation & Lifecycle management of INDs, NDAs, ANDAs, DMFs, CEPs, etc for regulatory submission
  • Support for 505(b)(2) regulatory Submissions

General Drug Development Consultancy

  • Dissolution and other Analytical Method Development & Validation
  • Specification Setting and Rationale
  • Stability issues
  • Formulation Development
  • Bio-pharmaceutics
  • Modeling and simulations
  • Overall design of Drug Development Programs