BIOLOGIC DRUG DEVELOPMENT AND REGULATORY APPROVAL PROCESSES ARE COMPLEX AND HIGHLY NUANCED
We provide counsel and critical insights into Industry thinking at every step of the drug development process. We have extensive experience in providing regulatory and drug development consulting services to developers and manufacturers. We’re the experts you want on your team.
DSI is proud to offer more than CMC consulting and regulatory support to our clients – once we are on-board, we view ourselves as your partner. Our mission is to provide guidance and value at every step of the drug development process, from conception to clinical trials through commercialization. Regardless of the stage of your product’s development, the DSI team brings the technical expertise and industry experience necessary to step in and provide hands-on support to your team.
Knowledge and Hands-on Experience in Hundreds of Successful Applications and Regulatory Submissions
The prerequisite Investigational New Drug Application (IND) spans the full spectrum of the drug development pathway ultimately to the Biologics License Application (BLA). Our breadth of experience allows us to develop comprehensive strategies and drug development plans to position clients for successful product outcomes and regulatory approvals. For each engagement, we leverage our knowledge and hands-on experience in creating drug development pathways and maneuvering, through the relevant nuances, to position our clients for successful outcomes and regulatory approvals.
Every Step of the Way:
DSI’s Biologic Expertise
- Our technical and regulatory consultants collaborate with your team to assess your drug development plan, identify the appropriate pathway for approval, define all applicable scientific and regulatory requirements, review critical business objectives, develop test method plans and craft a customized drug development strategy that minimizes cost and time to clinical trials, regulatory approval and commercialization.
- DSI will work with your team to manage your preliminary testing, provide hands-on leadership at early meetings with the FDA, EMA as well as supporting your regulatory submission with pre-IND and IND consulting to ensure the best possible submission including advice on Orphan Drugs Designation, Fast Track, Break-through Therapy, Accelerated Approval, and Biosimilar product submissions.
- During this stage, the DSI team, and integral project management, supports your clinical trial efforts with quality/compliance and regulatory consulting services customized to your product. Once an IND is allowed to proceed, the clinical investigational stage of development begins. From selecting the vendor for clinical trial material to the oversight of manufacturing and development studies by CMOs, establishing stability indicating testing methodology, to a “phase appropriate” recommendation or review of data generated by pre IND studies, our regulatory team brings strategic insights, compliance knowledge and industry experience necessary to ensure your development studies are successful and part of an efficient overall regulatory strategy.
End of Phase 2
- After the IND has progressed, DSI will provide your drug development team with advice every step of the way during the IND process. Our consultants leverage their unique “industry” perspective to help generate the “right” data and interpret Agency requests and communications as well as to provide guidance on the latest thinking, positioning your new product for a successful outcome. Our team prides itself on quickly and accurately interpreting EOP2 requests and comments, not giving the most conservative advice but the advice we would stand behind and support, eliminating the guesswork and costly delays that plague many interactions that could delay Phase 3.
Phase 3 Pivotal
- In addition to our expertise in quality/compliance and regulatory consulting, DSI also has a team of experts in product manufacturing and testing requirements – knowledge that we leverage to boost your chances of a successful Marketing application. Successful applications require that GMPs are strictly adhered to throughout every step of the application process to ensure every lot is substantially equivalent, safe and effective. The DSI team brings decades of experience in establishing drug development plans that encompass all aspects of testing, manufacturing, stability, storage, commercial packaging and labelling and distribution, so you can rest assured that your project and operations are fully compliant with FDA regulations. For clients that already have projects in place DSI can conduct gap-risk assessments of programs, filings and contractors to give that added confidence that your product will be successful.
- With a number of successful Biologics License applications (BLAs) collectively (full and supported) submitted in the past ten years, the DSI team is well positioned to assist your organization in the content authoring and preparation of your marketing application. Before and during the submission process, we provide hands-on support, leadership at agency meetings and guidance in interpreting CBER, and CDER interactions. Our team can help translate development data and reports into a compelling story that will resonate with FDA reviewers, evaluate supply chain options and review gaps in development and reasons why guidance was not followed to ensure accuracy, compliance and the best possible outcomes for your submission.
- Once your product has been approved and is ready to go to market, the DSI team is able to provide continued assistance in overseeing manufacturing and quality control; drafting required updates for the annual report, authoring of post approval change control, as well as assisting your team through additional development and commercialization processes, including re-positioning the application for international regulatory approvals for life cycle products.