Strategic planning is an essential key element for the success of your product development plan and assures successful submission in the shortest possible time to the regulatory authorities.
Strategic planning is not only thinking globally, or looking at your development project from a very broad, long-range perspective. The strategic planning guides the overall management and budget of the project and should be done as early as possible during the establishment of the R&D programs to set up clear vision of the road to regulatory approvals. Many medical products fail, simply due to the lack of an integrated well established development plan.
B.R.D. provides a consulting scaffold and supports your company team, based on a regulatory approach, allowing you to build a product development plan that fit the size and needs of your organization. The suggested work plan is supported by sound regulatory perspective to help you decide on the optimal strategy for your portfolio and product development plan.
This strategy will include assessment of your current stage, thinking through what actions you take, how to structure your pre clinical studies, prioritization of CMC or design plans, what and how you document R&D activities, how to structure your clinical trial, what submission process to take etc.
Major activities include:
- Determination of the regulatory product development track
- FDA/ EU regulatory search for relevant guidelines
- FDA intelligence for drug approval packages (NDA, ANDA and other equivalent therapeutic approvals)
- Strategy development for IND, NDA, and BLA preparation and submission
- Strategy development for distinct development approaches for Orphan Drugs Designation, Fast Track, Break-through Therapy, Accelerated Approval, ANDA and 505(b)(2) preparation and submissions
- Strategy development for DMF preparation
- Preparation review and filing of regulatory packages in CTD format
- Preparation of Investigational Medicinal Product Dossiers (IMPD) and CTA for competent authorities in the EU
- FDA intelligence for determining existence of substantial equivalent approvals
- Strategy development for 510(k), PMA, IDE preparation and submissions
- Assessment of company existing knowhow and development project documentation
- Preparation of a gap analysis report to indentify deficient essential requirements to support the regulatory authorities
- Preparation of development milestones plan up to approval
- Preparation planning and conduct of meetings with the FDA (US), EMA – Scientific Advice Working Party (EU), MOH (Israel) and other regulatory authorities as required
- Liaison with the FDA / EMA regulatory agency on the different CTD modules’ matters
- B.R.D acts as local representative for US and EU submissions for the Israeli MOH
- Establishment of Scientific Advisory Board (SAB)