Regulatory Strategy

Clinical Development Solutions seeks to provide our clients with a strong regulatory strategy, designed specifically for your product an its stage of development.

An effective Regulatory Strategy serves as a planning tool to track key milestones and summarize critical development issues that impact cost and time, as well as a record of key agreements made with Health Authorities.

Our tailored regulatory strategies will address the following questions:

  • Product Classification (e.g is the product a drug? device? combination product?)

    • If a device, determine device class in each jurisdiction for which marketing clearance is sought. For US development, is there a legally marketed predicate?

  • Background information and comparison with competitor products

  • Review relevant regulations and guidance documents, taking into consideration regional differences and impact

  • Potential for orphan status, breakthrough designation, accelerated approval, fast-track status, priority review, market exclusivity, special protocol assistance

  • Health Authorities Communication Plan – when and who to meet with (pre-IND/pre-CTA, pre-submissions/pre-NDA/NDS, pre-BLA, Scientific Advice/Protocol Assistance), and what issues to discuss

  • Development of target product profile, desired labeling/marketing claims

  • Requirements for pediatric studies

  • Preclinical and Clinical Development Plan (number of studies, appropriate endpoints that can support desired labeling claims, study design, placebo vs active comparator groups, patient population, statistical analysis plans, safety database)

  • Manufacturing Considerations for API, final product, packaging, labeling, testing, scale-up

  • Quality System considerations for devices (e.g. obtaining ISO 13485)

  • Filing Strategies – target submission/approval dates, strategy for pre-submission meetings, regional differences in filing requirements

  • Lifecyle Management – labeling changes, post-approval manufacturing changes, new indications, etc.

Ready to experience the CDS Difference?

Get in touch with our team to see how we can meet your organization’s needs.