Along with a strong Regulatory Strategy, your organization will need a robust Quality System. Learn how CDS experts can create one for your organization.

A CDS Regulatory Strategy designed specifically for your product and its stage of development, 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.