Guide to CMC Regulatory Drug Development Pathway
Assisting clients in Regulatory CMC Drug Development and strategic planning including small molecules and biologics, to determine which development strategies and regulatory submissions are appropriate and conform to policies, regulations and guidance for manufacturing process and analytical methodologies.
The Importance of Regulatory Strategy
How can you make sure your product gets to market as quickly and efficiently as possible? The key is a sound regulatory strategy. Without a strategy, you will be unable to anticipate challenges and important submission requirements. To learn more about our Regulatory Affairs consulting services and capabilities, contact us today.
As an FDA consulting firm, we offer Strategic, Execution and Project Management support for the submission lifecycle of drug, biologic, or regenerative products and vaccines, from pre-IND through licensure including the creation of and adherence to project timelines, monitoring of project resources, tasks, and budget, integration of multiple functional experts for application review and maintenance, attendance at FDA-Sponsor meetings, and experience with regulatory agency requirements and guidance.
Our Project-Based Regulatory Strategy & Submission Services
Whether this is the first or next product you have brought to market, careful preparation for each milestone and possible challenge is necessary or your entire development strategy could be derailed. Planning is key to this process, and knowledge of each regulatory agency’s intricacies is a major plus.
Regulatory Agency Representation
Meetings with regulatory agencies are invaluable in better understanding Agency expectations about the data necessary to support regulatory actions. The questions a sponsor asks, the way in which they are asked, and the discussions around those questions can reduce the data burden and smooth the path to clinical study or product marketing approval or clearance. We have prepared close to 100 meeting requests and packages and prepared clients for effective regulatory agency meetings. Let our expertise in Regulatory Agency Representation guide you through this process.
Every interaction with the FDA/EMA is a crucial moment for your development program, and meetings represent a culmination of compiled and scheduled work. Strategies, timelines, costs and complexity are all organized through this interaction — the stakes are high, and the outcomes are extremely important. It all comes down to strategic communication. Every facet of FDA/EMA meetings — from the information your company is providing, to scientific research and the tone and articulation of that information — must be conducted flawlessly. DSI will compose your communications for submissions and perform all preparation for these meetings. From experience, we know the nuances at play when expressing understanding of laws and issues, and how to analyze and interpret data accurately to present it clearly and concisely through written documents and in-person meetings.
- Pre-IND, End of Phase 2 and other Agency meetings
- Pre-NDA/BLA meetings and other pre-approval meetings
- Scientific advice meetings
Regulatory Strategy Development
A regulatory strategic plan is critical to defining the overall product development plan and the fastest path to marketing. It considers regulatory agency expectations and precedence for the technical, nonclinical, and clinical data necessary to support a regulatory action. The strategic plan provides timelines and milestones for necessary activities and the implications of delays. As a tracking and planning tool, and a living document, it allows sponsors to manage resources and corporate expectations. Because DSI has expertise in all aspects of healthcare product development and testing, we are uniquely suited to provide regulatory strategic support.
- Evaluate and provide guidance on all aspects of regulatory strategy
- Advise on expedited drug development, 505(b)(1), 505(b)(2) and ANDA submissions
Management and Preparation of Regulatory Submissions
Regulatory submissions are packages of information and data needed by a regulatory agency to determine whether a regulated healthcare product may proceed to clinical testing or whether is safe and effective for marketing. We prepare persuasive regulatory submissions that maximize the likelihood of a favorable regulatory agency review, including CMC sections (Quality modules 2 and 3) of regulatory documents; INDs and IMPDs, including amendments and supplements; NDAs, BLAs and CTAs and MAAs; including amendments and supplements; and DMFs.
Based on our success with 505(b)(2) submissions, our distinctive process for these applications is one of the most efficient and effective in the industry. DSI’s demonstrated success with this type of application derives from our detailed knowledge of FDA filing requirements, use of established and well-accepted methodologies and knowledge of content expectations for the Common Technical Document (CTD).
- IND and IMPD Preparation and Submission
- NDA, BLA and MAA, DMF Preparation and Submission
- Agency Meeting Briefing books
Responses To Regulatory Challenges
Not infrequently, regulatory agency review of a submission leads to requests for additional data (technical, nonclinical, or clinical), re-analysis of existing data, or clarification of information. These can hold up clearances to conduct clinical studies or marketing approval clearances or approvals. We have expertise in all aspects of healthcare product development and testing and can work with sponsors to develop responses to regulatory challenges or to implement programs necessary to collect information address data gaps.
- Advice on regulatory options and potential pathways
- Responses to Complete response letters (CRL) or clinical holds
Breakthrough Therapy Designation Requests
Sponsors seek breakthrough designation for their drug and indication because of the many benefits it offers. For some indications, the rarity of the disease or condition is apparent, and for expedited development CMC is always the bottleneck. It is an art to identify a strategy that is not transparent in the Guidance to meet the criteria for marketing approval. We prepare and submit designation requests that are scientifically sound and well supported with a proposed strategy.
Cell and Gene Therapy Programs
Overcome complicated and unique challenges in the development and commercialization of your New Active Substances (Gene and Cell Therapy) program. We supply sponsors with recommendations on how to provide sufficient CMC information to assure safety, identity, quality, purity and strength/potency of investigational gene therapy products.
In addition, we provide assistance in gene therapy investigation new drug application submissions. These regulatory strategies apply to human gene therapies and to combination products that contain a human gene therapy in combination with a drug or device.