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 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
Â
Â
