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 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
- 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
- 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
- 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
- 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
- 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
- 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
Learning Portal
At A Glance: Scientific and Strategic Development Services
At A Glance: Clinical Pharmacology
At A Glance: Nonclinical Regulatory and Strategy
Article: Here’s What Sponsors Need to Know About the Race for Children Act
Article: Considerations for Clinical Drug-Drug Interaction Studies
Article: Gene Therapies in Rare Disease
At A Glance: Clinical Regulatory and Strategy
