02. Consulting Services

Regulatory Expertise for Every Stage of Drug Product Development

 

Whether you have in-house modeling support or are working with our experts for your project, our Regulatory Strategies Center of Excellence team can help you with regulatory questions and strategic consulting, such as:

  • Risk Assessment and Strategic Consulting
    • Comprehensive evaluation of data across non-clinical, CMC, biopharmaceutics, clinical pharmacology and clinical domains
    • Identification and mitigation of regulatory and compliance risks
    • Development of risk management plans aligned with regulatory guidelines
    • Development of comprehensive regulatory strategies for drug development programs
    • Gap analysis and roadmap development for successful regulatory submissions
    • Represent your team in regulatory interactions
  • Biopharmaceutics Consulting
    • Strategies for formulation development and optimization
    • Support in identification of drug product failure modes based on composition, release mechanism and entirety of dissolution data
    • Advice on clinical strategies to support safe space definition and drug product variant selection
    • Strategies for dissolution method development and assessment of discrimination and biopredictive potential
    • Guidance on bioavailability and bioequivalence studies (eg., food/formulation effects)
    • Support for biowaiver justifications and regulatory submissions (eg., BCS-based, safe space-based)
    • Setting of clinically relevant specifications via establishment of dissolution safe space informed with and without physiologically based biopharmaceutics modeling (PBBM)
    • Design the regulatory strategy for your generic product (e.g., in vivo BE studies to be conducted and those that can be waived, e.g. fed state studies, PPI studies, strengths to be tested in vivo)
    • Alternative strategies to bioequivalence assessment of complex generic drug products, including locally acting drug products and long-acting injectables
  • Clinical Pharmacology Consulting
    • Design of overall drug development plans, with integration of clinical pharmacology data
    • First in human (FIH) dose predictions
    • Design, analysis, and interpretation of pharmacokinetic (PK), pharmacodynamic (PD) and PK/PD studies from Phase I to Phase IV eg, SAD, MAD, relative BA, DDI, specific populations, ECG (TQT) studies, Phase 2-3 efficacy and safety studies
    • Simulation of clinical studies and estimation of successful outcomes with different study setups (number of participants, inclusion criteria, doses), profiling against competitors
    • Dose selection and optimization strategies
  • Modeling and Simulation Regulatory Applications
    • Application of pharmacometric modeling to pharmacokinetics and pharmacodynamics, including biomarkers, efficacy, and safety (eg., popPK, popPK/PD, and PBPK/PBBM) to inform drug development
    • Application of quantitative systems pharmacology (QSP) to predict clinical outcomes and optimize clinical trials designs
    • Application of dose-response and exposure-response analyses
    • Development and application of IVIVR/IVIVC, safe space
    • Strategies for modeling de-risking. This can include:
      • Supporting data for regulatory claims: using risk assessments, such as in biopharmaceutics, to reduce the reliance on the model as standalone evidence for regulatory approvals
      • Stress testing: simulating different scenarios (e.g., edge cases or unusual conditions) to assess model performance and detect weaknesses
    • Planning and coordination between different analysis modalities
  • Regulatory Submission Support
    • Preparation of clinical pharmacology and biopharmaceutics sections for regulatory submissions worldwide (e.g. FDA (USA), EMA (EU), PMDA (Japan), MHRA (UK), ANVISA (Brazil), COFEPRIS (Mexico), HC (Canada) and others)
    • Responses to regulatory agency queries and preparation for meetings
    • Strategic advice on regulatory interactions and submissions
  •  Scientific and Technical Writing
    • Preparation of technical documents, including study protocols, data analysis plans, reports, and summary documents
      • Creation of strategic reports/ documents for regulatory agency interactions that incorporate modeling and simulation strategies (eg., MIDD plans)
    • Scientific writing support for regulatory documents (eg., modules 2.7.1, 2.7.2., 2.5.1, 2.5.2, briefing documents, regulatory responses)

03. Experts

Meet the Experts: Across the Company

Our Regulatory Strategies Center of Excellence team is comprised of experienced scientists and former regulators, with a broad range of expertise in areas including pre-clinical, biopharmaceutics, clinical pharmacology, and clinical and modeling backgrounds. They’ve worked alongside major regulatory agencies, in pharmaceutical companies, and for consulting services.