Development of Technical and Regulatory Strategies

Home Services Development of Technical and Regulatory Strategies

The level of inherent risk involved in the development of advanced biopharmaceutical products has now elevated than what was predicted earlier. The regulatory environment has been fire-eating ever since pharmaceutical drugs became more complex. Holistic strategic planning across a drug development program can determine logical next steps and rational decision making. At BLA Regulatory, we also understand that regulatory strategy is aimed at defining the crucial issues that are required to be practically discussed with regulatory authorities and program milestones that can be used as business catalysts for driving investors’ interest and financing. Our tailored approach incorporates the following criteria to any regulatory strategy program:

  • Fundamental target product profile
  • Changing regulatory environment
  • Facilitate new development tools
  • Predictable future approval requisites
  • Proactively recognize challenges
  • Distinguish key opportunities
  • Eliminate development risk

Our technical expertise ranges over a broad spectrum:

    • CMC – Identity, Purity, Potency, Stability, Control of Drug Substance and Product; Process development, Characterization, and Validation; Comparability, for
      • Small Molecule Drugs
      • Large Molecule Drugs
      • Gene and Cellular Therapies
    • Nonclinical – Drug Metabolism; Pharmacokinetics (in vitro and in vivo); Toxicology
    • Clinical – Pharmacology (pharmacodynamics, pharmacokinetics, adverse drug-drug interactions); Protocol Development (study phase, study population, dose selection, safety monitoring plan); Investigator’s Brochure
    • Predictable future approval requisites
    • Regulatory
      • Small Molecule Drugs
      • Large Molecule Drugs
      • Gene and Cellular Therapies