Comprehensive
Regulatory
Affairs Support
Pathway Assessment
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Defining claims and regulatory pathway
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Product Classification and risk determination
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Identification of applicable unique designations such as ODD, BDE, Fast Track, PRV, De Novo, or PRIME
Data Collection & Study Design
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Defining required Nonclinical Studies
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Clinical Studies startup materials
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Phases I/II/III study design support and protocol reviews
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Design History File requirements
Agency engagement
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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 ​
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Global expertise
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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
Streamlining your path to market approval
Built-in efficiency
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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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