Experience

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.

Nature of Products

  • Pharmaceuticals
  • Biologics
  • Combination products

Technologies

  • Biosimilars
  • Monoclonal antibodies
  • Drug delivery platforms
  • Cellular and Gene therapy products
  • Peptide drugs
  • Personalized medicine

OUR DIFFERENCE MATTERS

  • Our team provides a strategic approach to regulatory planning and product development.
  • We provide a continuity of service from the laboratory to the pharmacy shelf and beyond.
  • We are not a contract research organization (CRO). We are a strategy-based group of technical scientists and Regulatory CMC authors.
  • We are an experienced, industry-trained, hands-on group of pharmaceutical development professionals who have been involved with all aspects of clinical, CMC, drug, and medical device combination development.
  • We function as an extension of your team to help you leverage your company's expertise and knowledge in a way that is consistent with your corporate objectives.


LEVERAGE OUR EXPERIENCE

  • Our team has developed long-term relationships and a history of interactions with global regulatory agencies.
  • We prepare global dossiers (leveraging application preparation strategies to allow significant parts to easily support marketing application submissions in more than one ICH region).
  • Our consultants utilize proprietary content templates compliant with ICH and FDA regulatory requirements and technical expectations.