DSI provides regulatory, technical, and project management consulting services to healthcare product companies that manufacture and/or market pharmaceuticals, biopharmaceuticals, and cellular and gene therapy products.
Since 2007 we have provided our clients with innovative strategies and exceptional quality work products intended to enhance product development, approval, and marketing presence.
Whether advocating CMC strategy, directing CMC operations, or developing CMC submission content that represents the best interests of emerging biotech, we focus on the critical CMC issues and build programs that enhance development.
OUR DIFFERENCE MATTERS
- Our team provides a strategic approach to regulatory planning and product development.
- We provide a continuity of service from the laboratory to the pharmacy shelf and beyond.
- We are not a contract research organization (CRO). We are a strategy-based group of technical scientists and Regulatory CMC authors.
- We are an experienced, industry-trained, hands-on group of pharmaceutical development professionals who have been involved with all aspects of clinical, CMC, drug, and medical device combination development.
- We function as an extension of your team to help you leverage your company's expertise and knowledge in a way that is consistent with your corporate objectives.
LEVERAGE OUR EXPERIENCE
- Our team has developed long-term relationships and a history of interactions with global regulatory agencies.
- We prepare global dossiers (leveraging application preparation strategies to allow significant parts to easily support marketing application submissions in more than one ICH region).
- Our consultants utilize proprietary content templates compliant with ICH and FDA regulatory requirements and technical expectations.
OUR SOLUTIONS
- Product analysis, product development plans, and regulatory strategies utilizing:
- Fast track designation
- Breakthrough therapy designation
- Accelerated approval pathway
- Priority review designation
- Consultation for expedited program designation
- Serious condition assessment
- Available therapy assessment
- Unmet medical need assessment
- Regulatory document preparation
- Liaison with US FDA
- Regulatory agency meeting preparation (including the meeting request, planning, information package, minutes, and follow-up
- Selection, qualification, and oversight of product development contractors
- Consultation on and development of a rapid manufacturing development program to accommodate theaccelerated pace of the clinical program
- Assessment of the benefit-risk regarding less chemistry, manufacturing, and controls (CMC) information versus patient benefit
- Management of a commercial manufacturing program
- Audits to ensure clinical and manufacturing facilities inspection readiness
- Consultation on the proposed labeling and post-marketing requirements
HOW WE HELP
- We have over a decade of experience in CMC and regulatory consulting and regulatory submissions.
- Experience in all major therapeutic areas and all classes of pharmaceutical products, with more than 30 product approvals, including pharmaceutical, biologic, generic, combination, and veterinary products
- We have a track record of successful interactions with global regulatory agencies.
- We prepare dossiers (leveraging application preparation strategies to allow significant parts to easily support marketing application submissions in more than one ICH region).
- Our consultants utilize proprietary content templates compliant with ICH and FDA regulatory requirements and technical expectations.
- A commitment to quality, efficiency, and our clients’ needs
- The leveraged resources of a large network