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Comprehensive
Regulatory
Affairs Support

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Pathway Assessment

  • Defining claims and regulatory pathway
     

  • Product Classification and risk determination
     

  • Identification of applicable unique designations such as ODD, BDE, Fast Track, PRV, De Novo, or PRIME

Data Collection & Study Design

  • Defining required Nonclinical Studies
     

  • Clinical Studies startup materials
     

  • Phases I/II/III study design support and protocol reviews
     

  • Design History File requirements

Agency engagement

  • Defining regulatory engagement plans 

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  • Facilitating Q-Submissions, teleconferences, and Pre-IND/IDE meetings

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  • Serving as organizational regulatory point-of-contact â€‹

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Global expertise

  • In-depth knowledge of product-specific regulatory requirements across key jurisdictions across the US, EU, UK, and Asia

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  • Direct experience with international product approvals and licensing in Canada, Switzerland, United Kingdom, Australia, and Japan

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  • Providing comprehensive regulatory gap analysis to facilitate market expansion with key focus on monitoring and adapting to changes in FDA, EMA, MDR/IVDR, and ICH guidelines as well as other governance

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Image by National Cancer Institute

Streamlining your path to market approval

Pharmaceuticals

  • Pre-clinical studies and technology transfer oversight

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  • ​Full life-cycle IND/CTA/ANDA/NDA/MAA​ design​

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  • Post-market safety monitoring plans

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  • Repositioning and reformulation support

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Biologics

  • BLA/MAA support, 351(a) and 351(k) pathways​​​​​

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  • ​Critical pre-BLA gap analysis and harmonization of CMC, nonclinical, and regulatory processes

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  • Expert guidance for therapies with novel or complex regulatory profiles 

Devices & Diagnostics

  • Comprehensive preparation for Q-submissions such as Pre-IDE, Pre-RFD, 513(g) including identification of reference and/or predicate devices

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  • BDE and de novo classification requests

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  • Full life-cycle 510k, PMA preparation 

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  • CDRH and EU-MDR/IVDR engagement mediation

Combination Products

  • Determining Primary Mode of Action (PMOA) 

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  • Identifying appropriate regulatory pathway (e.g., IND or IDE, NDA, PMA, 505(b)(2))

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  • Identifying and preparing for necessary Bridging Studies

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Built-in efficiency

  • S&D Consulting's approach to supporting early stage ventures integrates regulatory strategy and risk analysis into the development process to minimize costly delays and re-works​​

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  • Applying extensive experience with grant-funded labs, scaling startups and pre-M&A ventures along with technical and creative partnerships to provide holistic growth solutions through flexible tailored contracts​​​

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Are you a startup?

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