Let Our Breadth Of Experience And Depth Of Knowledge Work For You

Our professional consultants have accumulated experience with products representing current and new technologies across many products and technologies.

The DSI difference is the unique combination of expertise we have under one roof – from pre-IND and IND through clinical trials and product development to commercial launch and beyond.

Our team brings a depth of knowledge and breadth of experience across product types and development pathways, allowing us to address the full scope of a client's regulatory and product development needs. Our experts possess unmatched insight and experience in both the regulatory and product development processes. Most have held positions within industry and/or were senior leaders with emerging biotech experience, and during their careers have played instrumental roles in constructing the strategies and experiences that they continue to use today. All are hands-on professionals with an intimate knowledge of the scientific, regulatory and business challenges that must be overcome in order to bring a new product to market.

When you work with DSI, an experienced subject-matter expert is always just a phone call away. No firm can match DSI’s depth of knowledge, breadth of experience and track record of success across the pharmaceutical, and biologics sectors.

Dosage Forms

  • Oral
  • Parenterals (liquid & lyo)
  • Inhalation
  • Topicals
  • Transdermal
  • Liposomes
  • Combination Products

Drug Types

  • Abuse/Addiction
  • Aesthetic Medicine
  • Allergies
  • Anesthesia
  • Biodefense
  • Bone Diseases
  • Cardiology/Vascular Diseases
  • Dental and Oral Health
  • Dermatology
  • Endocrinology
  • Gastroenterology
  • Genetic Disease
  • Gerontology
  • Hematology
  • Hepatology (Liver, Pancreatic, Gall Bladder)
  • Immunology
  • Infections and Infectious Diseases
  • Musculoskeletal
  • Nephrology


  • Neurology
  • Nutrition and Weight Loss
  • Obstetrics/Gynecology (Women’s Health)
  • Oncology
  • Ophthalmology
  • Otolaryngology (Ear, Nose, Throat)
  • Pain
  • Pediatrics/Neonatology
  • Podiatry
  • Psychiatry/Psychology
  • Pulmonary/Respiratory Diseases
  • Rare Disease
  • Rheumatology
  • Sleep
  • Toxicology
  • Trauma (Emergency, Injury, Surgery, Transplantation)
  • Urology
  • Vaccines

Every Step of the Way:
DSI’s Expertise

pre-IND and IND consulting













  • Our technical and regulatory consultants collaborate with your team to assess your drug development plan, identify the appropriate pathway for approval, define all applicable scientific and regulatory requirements, review critical business objectives, develop test methods and craft a customized drug development strategy that minimizes cost and time to clinical trials, regulatory approval and commercialization.
  • DSI will work with your team to manage your preliminary testing, provide hands-on leadership at early meetings with the FDA, EMA as well as support your regulatory submission with pre-IND, IND and IMPD consulting to ensure the best possible submission including advice on expedited programs .

Phase 1

  • During this stage, the DSI team, and integral project management, supports your clinical trial efforts with quality/compliance and regulatory consulting services customized to your product Once an IND is allowed to proceed, the clinical investigational stage of development begins. From selecting the vendor for clinical trial material to the oversight of manufacturing and development studies by CMOs, establishing stability indicating testing methodology, to a “phase appropriate” recommendation or review of data generated by pre IND studies, our regulatory team brings strategic insights, compliance knowledge and industry experience necessary to ensure your development studies are successful and part of an efficient overall regulatory strategy.

End of Phase 2

  • After the IND has progressed, DSI will provide your drug development team with advice every step of the way during the IND review process. Our consultants leverage their 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.

Phase 3 Pivotal

  • In addition to our expertise in quality/compliance and regulatory consulting, DSI also has a team of 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 throughout every step of the application process to ensure every lot is substantially equivalent, safe and effective. The DSI team brings decades of experience in establishing drug development plans that encompass all aspects of testing, manufacturing, stability, storage, commercial packaging and labelling and distribution, so you can rest assured that your project and operations are fully compliant with FDA regulations. For clients that already have projects in place DSI can conduct gap-risk assessments of programs, filings and contractors to give that added confidence that your product will be successful.

Pre-Marketing Application

  • With a number of successful filings, collectively (full and supported) submitted in the past ten years, the DSI team is well positioned to assist your organization in the content authoring and preparation of your marketing application. Before and during the submission process, we provide hands-on support, leadership at agency meetings and guidance in interpreting CBER, and CDER interactions. Our team can help translate development data and reports into a compelling story that will resonate with FDA reviewers, evaluate supply chain options and review gaps in development and reasons why guidance was not followed to ensure accuracy, compliance and the best possible outcomes for your submission.

Post Approval

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