Chemistry, Manufacturing, and Controls Regulatory Affairs Support

As an exploratory product edges closer to commercialization and finally to market, the CMC information is gathered, preserved, and updated for both the drug substance and drug product. DSI has prepared a number of successful CMC and quality sections of regulatory submissions. These include meeting packages, INDs and CMC Amendments, DMFs, NDAs, post approval CMC Supplements, Canadian NDSs, BLAs, European IMPDs and MAAs, and post approval variations IMPDs.

Getting it right from the beginning

Drug Development needs innovation, creativity, and a multiple disciplinary method in gaining a successful path to approval. A successful program can offer a valuable opportunity for a drug development firm.

The similarities in regulatory compliance between both small and large molecules means DSI is optimally positioned to aid in development and guidance for a successful, efficient drug development program and can create a valuable opportunity for any firm. DSI have a multidisciplinary team that involves in-house regulatory specialists, CMC, and subject matter experts who can enhance a firms likelihood of avoiding a clinical hold or a complete response letter due to CMC concerns.

DSI's regulatory strategy team

  • Leads the highest percentage of submissions of any team sending submissions to the FDA
  • Has guided more than 50 Marketing Application approvals
  • Holds 1 - 3 pre-IND meetings per month
  • Upholds a 100%+ FDA agreement rate for satisfying Marketing Application approval requirements
  • Provides wide-ranging therapeutic expertise: DSI has filed with every division of the FDA's Office of New Drugs many times
  • Has brought all kinds of products to market, for example, drugs with novel indications, branded generics, orphan drugs etc.
  • Has experience that covers all drug formulation and delivery types, for example, routes of administration, dosage forms, sterile/non-sterile etc.

The DSI process

DSI has an exceptional history of first-cycle FDA approvals which is evidence of their ability to be a successful FDA liaison and guarantee regulatory alignment each step of the way, from concept to commercialization. They offer regulatory advice and problem-solving in addition to advocacy on a firm’s behalf.

In some cases, clinical studies or IND programs could be put on clinical hold, but DSI has the capabilities to get involved and work with the FDA to put drug development programs back on track. DSI has an established process for FDA planning, execution and submissions in order to accomplish both development and corporate objectives. This is reflected through their extensive history of success with the agency and many returning clients.

  • Preparation and submission of Investigational New Drug
  • Pre- and post-Investigational New Drug and New Drug Marketing Application consultations with Agencies
  • Preparation and submission of INDs, IMPDs, NDAs, ANDAs, BLAs, CTAs, and DMFs

Drug development and regulatory approval strategy

The traditional method of drug development through the 505(b)(1) approval pathway takes an average of 12 years from start to finish. Conversely, a 505(b)(2) development program can be accomplished in just two to five years, however, this condensed development pathway needs expertise. DSI is skilled at directing the regulatory waters surrounding 505(b)(2).

The DSI team has particular skills in de-risking and condensing development programs. Specifically, they design development plans to obtain and present data, study reports and informed arguments to meet the strategic requirements of a company, address regulatory needs and satisfy the needs of target markets, which are usually niche markets.

Exacting feasibility assessments, gap analysis and common work requests (for example, IND, pre-INDs), means each step DSI takes moves toward feasible product approval, no matter the product form or therapeutic indication at hand.

Regulatory strategy

  • Advice on developmental, manufacturing, analytical, and supply chain issues, inclusive of registered starting material (RSM) selection and change control
  • Complete identification and documentation on supply chain
  • Assembly of CMC sections of INDs and NDAs
  • DMF preparation

Advantages

  • Top level industry specialist access
  • Effective resolution to regulatory problems
  • Regulatory Strategy for starting material designation (RSM)
  • Regulatory Strategy for organization
  • Streamline regulatory filings
  • IND, DMF, NDA document preparation for regulatory filings

About DS InPharmatics LLC

DS InPharmatics (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 represent the best interests of emerging biotech, we focus on the critical CMC issues and build programs that enhance development.


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Last updated: May 8, 2020 at 4:46 AM

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