Scientific & Strategic Development

Scientific & Strategic Development

Scientific & Strategic Development GraphicGet on the Right Path to Accelerate Your Research

The Scientific and Strategic Development (SSD) group is a team of regulatory strategists with an average of 19+ years of expertise in therapeutic development. Applying our experience with global and local regulatory authorities, competitive intelligence, and in-depth knowledge of the fluid landscape for drug and medical device approvals, we provide strategies to accelerate the global development of your medical therapeutics.

What we offer:

  • Global, regional, and country-specific strategies at all phases of therapeutic development based on current regulatory guidance and practice
  • Program gap analyses and due diligence for assets based on an understanding of the current regulatory and competitive landscape
  • Tactical and strategic development considerations including best approaches to mediate engagement with regulatory bodies
  • Unparalleled experience with advanced therapy medicinal products (ATMPs) including gene therapy, somatic-cell therapy, and tissue engineered medicines

A list of selected services for each functional area is provided below. Contact us for a comprehensive list, or to enquire about specific capabilities.

  • Global Regulatory and Competitive Intelligence – Leverage regulatory and global intelligence to build robust strategies
  • State-of-the-art Informatics and Data Analytics – Identify global regulatory precedence and trends to support tactical planning
  • Due diligence with Impact Analysis – Conduct due diligence assessments with impact analysis to guide and accelerate program deliverables
  • Advanced Signal Detection – Perpetual surveillance and assessment of commercial, investigational, regulatory and safety precedence signals
  • Market Intelligence – Monitor, analyze and report key insights related to competitor capabilities
  • Competitive Intelligence – Robust landscape analysis of clinical trial registries, market influences, and geographical nuances

Clinical Regulatory and Strategy

  • Global or country-specific regulatory strategy, clinical development plan and target product profiles
  • Guidance on country-specific regulatory requirements and legal basis
  • Mechanisms of acceleration for regulatory pathways
  • Evaluation of clinical trial design and selected endpoints for regulatory acceptability and approval
  • Negotiations with regulatory agencies on complex issues
  • Strategic advice on product information, labeling, differentiation and positioning
  • Benefit/risk assessment and risk mitigation strategies
  • Integration of Health Technology Assessments into clinical trials

Nonclinical Regulatory & Strategy Graphic

  • Scientific guidance, data interpretation, and strategic support for regulatory submissions and regulatory queries
  • Nonclinical program planning to support efficient clinical development from early safety evaluations to regulatory filings
  • Identification of target organs and support for clinical safety monitoring strategies
  • Determination of maximum recommended clinical starting doses using multiple approaches (NOAEL, MABEL, HNSTD)
  • Strategic utilization of nonclinical data to justify product impurities and CMC changes
  • Immunogenicity planning, anti-drug antibody (ADA) sampling, and mitigation strategies
  • Nonclinical study facilitation — nonclinical CRO interactions; review and input on proposals, protocols, and study designs; data interpretation; impact assessment
  • Due diligence support for in-licensing opportunities

CMC Regulatory and Strategy Image

  • Regulatory assessment and gap analysis
  • CMC regulatory strategic development
  • Global support of CMC submissions from early phase development to commercialization
  • Preparation and review of:
    • Briefing Documents
    • Investigator’s Brochures (IB)
    • Investigational New Drug applications (IND – Module 3 / 2.3)
    • Investigational Medicinal Product Dossiers (IMPD)
    • Drug Clinical Development Dossiers (DDCM)
    • New Drug Applications (NDA) and Biologics License Applications (BLA)
    • Marketing Authorization Applications (MAA)
  • Experience with multiple products (chemicals, biologicals, ATMPs, conjugated products, …)
  • All dosage forms and routes of administration
  • Regulatory agency meetings

Clinical Pharmacology Graphic

  • Optimal integration of nonclinical data into clinical trial design (including human dose determination, elucidation of mechanism-of-action, & acceleration to proof-of-concept)
  • Development of SAD and MAD study designs, including effective sampling strategies
  • Critical evaluation of available information to inform on use in special populations (geriatric, pediatric, renal/hepatic impairment, ethnic groups) and potential for drug-drug interactions
  • Leveraging regulatory and competitive intelligence to optimize the clinical pharmacology program to avoid unnecessary clinical assessments
  • Strategically positioning clinical pharmacology to maximize the value of your clinical program
  • Industry-leading guidance and support for scientific advice meetings with Health Authorities
  • Development and critical evaluation of the clinical pharmacology program in-line with regulatory expectations

Scientific and Strategic Development - Medical Devices & Diagnostics

  • Regulatory strategy development and pathways to market
  • Device classification determination, intended use statement development and predicate device determination
  • Pre-market, post-approval and post-market support
  • Appraisal and evaluation of technical documentation
  • Preliminary assessment and gap analysis
  • Technical files, design dossiers and quality management system support
  • European authorized representation services and UK responsible person services
  • Notified Body discussions and pre-submission FDA meetings

Scientific and Strategic Development - Combination Products

  • Global regulatory and development strategy to facilitate path to market of combination products with drugs, biologics, devices, and in-vitro diagnostics
  • Assessment of the product’s primary mode of action and determination of product’s classification and regulatory pathways
  • Gap analysis to fulfill applicable regional and country-specific regulatory requirements
  • Guidance to create an integrated clinical and regulatory strategy to enable product development to meet clinical milestones
  • Scientific and strategic support for regulatory document development and interactions with Regulatory Authorities and Notified Bodies