We recognize that regulatory requirements and concerns are intricately woven into product development, launch, and life cycle planning. We provide regulatory insight, strategy, and writing support that complements our other core capabilities. We can support your strategy as you align the regulatory activities required to bring your product to market with your company’s core business objectives.
Some reasons why our clients call upon us
- Our team uses the big picture perspective to better understand the regulatory needs in the context of overall strategy
- We provide comprehensive solutions, allowing clients to unify business development, economic, and regulatory objectives to best solve industry and research challenges
Some examples of the work we do
- Regulatory considerations for lead target indication strategy (e.g., orphan designations)
- Competitive assessment of technology/drug class within target markets
- Regulatory competitive intelligence
- Strategic Principal Investigator/trial site identification (e.g., Research Consortiums)
- IRB perspective: identification of technology/product data gaps or study risk assessment
- Writing support for pre-clinical or clinical study reports to accompany regulatory pre-clinical/clinical packages or updates
- Creation of Product Monographs, Package Inserts, etc.
- Writing to position nonclinical safety data and findings to clinicians
- Investigators’ brochures
- Writing support for nonclinical and clinical sections for modules 2, 4, and 5 of the common technical document (CTD)
- Facilitation of collaborative strategy meetings to identify the right subject matter experts and to assess the strengths and limitations of available regulatory pathways to ensure smooth regulatory navigation
- Essential regulatory and clinical trial documents (selected examples below):
- Comprehensive briefing books and meeting requests tailored for specific interactions with the FDA, with strategic integration of real-world evidence and systematic literature reviews/meta-analyses to drive regulatory decision-making
- Clinical trial diversity plans aligned with FDA standards to strategically address participation barriers, ensure diverse representation, and foster broad applicability of study findings
- Patient-reported outcome measures and data to support label claims and marketing applications