Pharmaceutical Regulatory Submission Preparation and Management

Regulatory submissions are packages of information and data needed by a regulatory agency to establish whether a regulated healthcare product can progress to clinical testing or whether it is safe and effective for marketing.

DS InPharmatics (DSI) offers preparations of persuasive regulatory submissions that optimize the probability of a positive regulatory agency review, including CMC sections (Quality modules 2 and 3) of regulatory documents for al investigation applications; INDs and IMPDs, CTAs, in addition to marketing applications; NDAs, BLAs and MAAs; this includes amendments and supplements; and DMFs.

Submission project management

Organization and efficiency can create a project manager that is the difference maker in the implementation of a successful authoring project. DSI Regulatory Project Managers have the following qualities:

  • Ann extensive knowledge of Agency regulations, guidance and expectations built on first-hand experience
  • FDA project managers and reviewers are available daily as the main point of contact for clients
  • They follow trends within Centers and Divisions on the basis of current practices
  • Offer guidance on regulatory and product development
  • They are available as a primary point of contact for project coordination
  • Organize writing, review, strategy discussions, publishing and application life cycle maintenance activities
  • Give advice on best practices to develop efficient, reviewer friendly applications
  • Offer guidance on regulation and submission
  • Available for accompaniment for Sponsors to FDA meetings and participate in teleconferences

CMC submission content development

DSI can author, review and publish original IND, NDA, BLA, DMF, and ANDA applications, amendments and supplements. DSI can develop or give assistance with the fine-tuning of regulatory strategy;

  • Services in Regulatory, Quality Assurance & Compliance for drugs and biologics
  • Quality-based production and analytical method development
  • Validation
  • Development of formulation
  • Assessment and evaluation of stability data and requirements
  • Regulatory submissions preparation and review
  • Risk-based approaches for product development
  • Oversight of contract services
  • Design, execution and advancement of production systems covering a variety of products including small molecules, biologics and biosimilars

Investigational new drug (IND and IMPD): Preparation and submission

The total quality of an investigational application is highly dependent on the amount to which the needs of the Agency regulations and guidance documents are met; the data quality and the presentation clarity; and the strength of the positions (interpretations and conclusions) made in the submission.

DSI has a team that is experienced regulatory professionals and subject matter experts. They understand how to assess product data and plan the regulatory strategy in addition to how to guarantee clarity, precision and reliability across documents to be encompassed in both investigational and marketing applications.

DSI has an established history of successful communication with the FDA and often liaise to organize and facilitate pre-IND consultations, end of Phase II consultations and pre-NDA consultations, in addition to preparing the required briefing documents. Additionally, DSI can offer assistance with the preparation and submission of application updates for CMC information amendments, supply chain changes and annual reports.

New drug application (NDA) 505(b)(1): Preparation and submission

DSI’s integrated regulatory solutions have been developed to improve the quality, organization and comprehensiveness of Agency applications. At each stage, it is guaranteed that four main criteria are met:

  • Inclusion of acceptable data, in combination with efficient interpretation of both compliance and conformance data, to support product approval
  • Applicable FDA regulations and guidance compliance
  • FDA reviewer requirements are met
  • CTD submissions completely follow specifications

New drug application (NDA) 505(b)(2): Preparation and submission

DSI’s success with 505(b)(2) submissions has led to a distinguishing process for these applications that is one of the most competent and effective in the industry. Harmonization of any marketing application occurs due to the nature of the 505(b)(2) and because the CMC information needed is exactly the same to that of the 505(b)(1). DSI’s verified success with this type of application comes from in-depth knowledge about the filing requirements, and the employment of recognized and well-accepted practices in drug development.

Biologic license application (BLA): Preparation and submission

DSI’s integrated regulatory solutions have been developed to improve the quality, organization and comprehensiveness of biological applications. At each stage, it is guaranteed that four main criteria are met:

  • Inclusion of acceptable data, combined with successful synthesis and interpretation of data, to support product approval
  • Applicable regulations and guidance for biologics compliance
  • FDA reviewer requirements are met
  • CTD submissions completely follow specifications

Abbreviated new drug application (ANDA) 505(j) submissions

DSI’s strategic method for effective ANDA submissions concentrates on collecting the suitable ANDA information to guarantee a comprehensive application while producing and gathering the correct data. DSI relies on years of experience to lessen compliance uncertainty.

Complex drug product preparation and submissions

The FDA describes complex generic drug products as:

  • “Products with complex active ingredients (e.g., peptides, polymeric compounds, complex mixtures of [active pharmaceutical ingredients], naturally sourced ingredients); complex formulations (e.g., liposomes, colloids); complex routes of delivery (e.g., locally acting drugs such as dermatological products and complex ophthalmological products and dosage forms that are formulated as suspensions, emulsions, or gels); or complex dosage forms (e.g., transdermals, metered dose inhalers, extended-release injectables);
  • Complex drug-device combination products (e.g., auto-injectors, metered dose inhalers); and
  • Other products where complexity or uncertainty concerning the approval pathway or possible alternative approach would benefit from early scientific engagement.”

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 4:28 AM

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