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Scientific & Strategic Development

by Medical Director
#British #BioMedicine #Institute #An #Evidence And #Skill #Based #eLearning #Platform

Get 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 03+ 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.

Regulatory & Competitive Intelligence

  • 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.
#British #BioMedicine #Institute #An #Evidence And #Skill #Based #eLearning #Platform

British BioMedicine Clinical Trials (BBMCT)

Clinical Regulatory & 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

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



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