CMC Regulatory Affairs Consulting

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 consulting services and capabilities, contact us today.

Regulatory Affairs Consulting Solutions

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.

Our CMC regulatory affairs consultants can assist with 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 offer insight and experience with regulatory agency requirements and guidance.

Contact Us to discuss our CMC Regulatory Affairs Consulting Services today!

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. Our experienced regulatory affairs consultants can help you meet your goals.

Regulatory Affairs Services


The DSI regulatory consulting team offers the experience and knowledge to guide the regulatory aspect of drug development from initial investigational submissions (IND, IMPD) through the final marketing application (NDA, MAA) process. DSI’s experts are adept at the strategic aspects of the regulatory process as well as being “hands-on” resources for drafting and publication of the submissions. Read more...

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. Read more...

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. Read more...

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. Read more...

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. Read more...

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. Read more...

505(b)(2) & Follow On Biologics

In the ever-competitive marketplace(s) you compete in, exclusivity is often the only way to secure a singular advantage. 505(b)(2) offers an opportunity for developers to secure up to three, five or — for orphan products — seven years of exclusivity. Moreover, there are intricacies that allow for extended exclusivity (e.g., if the FDA requests pediatric studies on a new drug, the drug may be eligible for six additional months of exclusivity). Read more...

Expedited Drug Developments

Pharmaceutical and biotechnology companies seeking to utilize at least one of the four FDA expedited programs—fast track designation, accelerated approval pathway, priority review designation, and most recently breakthrough therapy designation —can leverage our experience and expertise to bring their products to the market faster while staying in compliance with regulatory requirements. Read more...