ARE YOU DEVELOPING PRODUCTS WITH THE INTENTION OF MARKETING, LICENSING, OR DIVESTING?

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.

WHAT CAN YOU EXPECT FROM DSI?

All the expertise you need under one roof

There is no need to hire multiple consultants. DSI has all the expertise you need to advance your product development and regulatory approval programs.

Breadth of experience

DSI helps clients develop many types of regulated products. We have worked with companies to develop and obtain marketing clearance for drugs, and biologics in many therapeutic areas, including oncology, cardiovascular disease, metabolic disorders, and neurology.

Flexibility and responsiveness

We understand our client’s need to reach company goals quickly. We are there when you need us and can provide a quick answer to a question or full product development support.

Deep knowledge of regulatory expectations

Our understanding of regulatory expectations comes from knowledge gained from experiences with other clients, products, and regulatory agency interactions.

Professional, experienced consultants

DSI’s staff includes technical, and regulatory professionals, most with more than 15 years of experience in product development and marketed product support. DSI’s consultants have worked with FDA regulators in CMO’s and pharmaceutical and emerging biotech companies.

DUE DILIGENCE

REGULATORY AFFAIRS

CHEMISTRY MANUFACTURING
CONTROLS

QUALITY ASSURANCE

PROJECT MANAGEMENT

Every Step of the way: DSI’s Expertise

Our team of expert consultants bring decades of experience to every stage of the regulatory and product development process, from initial selection of development and manufacturing sources, design and evaluation of the investigational manufacturing process thru the scale-up for commercialization. This includes expertise in each of the following elements of the product development process: quality management, manufacturing, product comparability, process design and evaluation, GMP, and the regulatory strategy and compliance concurrent with each step.

LEARN MORE ABOUT DSI’S EXPERTISE
Regulatory drug development
DS InPharmatics (DSI) analytics checklist for with test tube white on yellow-orange icon

PRE-IND

Collaborate to assess your product development plan, identify the appropriate pathway for approval, define all applicable technical and regulatory requirements, support preparation of critical toxicology materials, develop test methods and craft a customized product development strategy that minimizes cost and time to clinical trials. Hands-on leadership at meetings with the Agency as well as support for your regulatory interaction and IND submission. Advice every step of the way during the IND review process.

DS InPharmatics (DSI) CMC Erlenmeyer flask on shield white on teal icon

PHASE 1

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 requests and comments, giving the not the most conservative advice but the advice we would stand behind and support, eliminating the guesswork and costly delays that plague many interactions.

DS InPharmatics (DSI) double-sided capsule and tablet with starred ribbon approval grey on beige icon

END OF PHASE 2

Integrated project management, supports your trial efforts with quality/compliance and regulatory customized to your product. From selecting the vendor for commercial material to the oversight of development studies and manufacturing, establishing stability indicating testing methodology, to a “phase appropriate” recommendation or review of data generated by Phase 3 studies, our regulatory CMC team brings strategic insights, compliance knowledge and industry experience necessary to ensure your studies are successful and part of an efficient overall regulatory strategy.

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PHASE 3 PIVOTAL

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 ensuring every lot is substantially equivalent, safe and effective. Established product development plans that encompass all aspects of testing, manufacturing, stability, storage, packaging and labelling and preparation for validation of manufacturing so you can rest assured that your operations are fully compliant. Gap-risk assessments of programs, filings and contractors to give that added confidence that your product will be successful.

DS InPharmatics (DSI) Erlenmeyer flask with arrow pointing to mouth white on light teal icon

PRE-MARKETING

Well positioned to assist your organization in preparing and submitting your marketing application (NDA/BLA/MAA). During the Authoring process, we provide hands-on support, leadership at agency meetings and guidance in interpreting Agency interactions. Our team can help translate development data and reports into a compelling story that will resonate with FDA reviewers, evaluate supply chain choices and justify any gaps in development and reasons why guidance was not followed to ensure accuracy, compliance and the best possible outcome. Hands on support and troubleshooting of issues during validation.

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POST APPROVAL

Once your product has been approved and is ready to go to market, the DSI team is able to provide assistance in overseeing manufacturing and quality control, drafting required updates and post approval change control for the FDA and assisting your team through additional development and commercialization processes, including re-positioning the FDA application for international regulatory approvals, life cycle products and physician materials.

DSI ANNOUNCES ITS ACQUISITION BY PRODUCTLIFE GROUP

We could not be more pleased to become part of a global leader in the life sciences regulatory and compliance industry. Joining PLG is exciting both for DSI as a business and for our clients, who will now have access to additional specialist expertise and international coverage spanning more than 100 countries.

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DSI's RECENT BLOG POSTS

March 22, 2024
Published by Meranda Parascandola at March 22, 2024

The Impact of FDA Fast Track and Accelerated Approval on Drug Development

The FDA Fast Track and Accelerated Approval pathways can expedite the review of new drugs. It is important to understand these pathways and how they impact drug development, as well as other industries, like healthcare and pharmaceutics.  FDA Fast Track Designation: Accelerating The Time During The Drug Development Process The […]
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February 9, 2024
Published by Meranda Parascandola at February 9, 2024

The Evolving Role of Data Integrity in Pharmaceutical Quality Assurance

In the realm of pharmaceuticals, data integrity stands as a cornerstone, underpinning the veracity of scientific research, the efficacy of drug development, and the safety of patient outcomes. This critical facet of pharmaceutical quality assurance has evolved significantly, particularly in the wake of advancing technology and stringent regulatory standards.  Our […]
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January 17, 2024
Published by Meranda Parascandola at January 17, 2024

U.S. Pharma’s Roadmap to EMA Approval: IMPDs and MAAs Uncovered

Introduction  U.S. companies face unique challenges and opportunities in the global race to develop and market new pharmaceuticals. A critical step in this journey is navigating the European Medicines Agency's (EMA) regulatory framework for Investigational Medicinal Product Dossier (IMPD) applications and Marketing Authorization Applications (MAAs). Understanding these processes is key […]
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January 16, 2024
Published by Meranda Parascandola at January 16, 2024

Harmonizing Global CMC Guidelines: A Roadmap to Streamlined Pharmaceutical Approvals

The pharmaceutical industry is growing through global collaboration and market expansion. To continue this growth, regulatory compliance for Chemistry, Manufacturing and Controls (CMC) must be followed. Without CMC regulatory compliance, the safety behind the creation of any products could be compromised.  CMC regulatory compliance is a topic that DS Inpharmatics […]
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REGULATORY AFFAIRS

  • Regulatory Agency Representation
  • Expert Regulatory Affairs Compliance Consultants
  • Regulatory Strategy Development
  • Management And Preparation Of Regulatory Submissions
  • Responses To Regulatory Challenges
  • Breakthrough Therapy Designation Requests
  • Gene and Cell Therapy Product Review
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CMC

  • Integrated CMC Development
  • Materials Characterization And Formulation Development
  • Process Development, Optimization, And Validation
  • Analytical Method Development, Optimization, and Validation
  • Stability Program Design And Management
  • Vendor And Contractor Identification and Management
  • Supply Chain Assessment and Management
  • CMC Regulatory Affairs Support
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QA

  • Design, Implementation, and Remediation of Quality Systems
  • Compliance, Vendor Qualification, and Mock Pre-approval Audits (Mock-pais)
  • Management of Compliance Situations
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