unsplash+horizontal.jpg

Regulatory Strategy

An effective Regulatory Strategy is a living document . . .

a planning tool to track key milestones and summarize critical development issues that impact cost and time.

It is also the hub for recording key agreements made with Health Authorities.

 
 
 
 
Regulatory Affairs team creating Regulatory Strategy
 

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.

 
unsplash+horizontal.jpg