Preclinical Development Services
Program and Project Leadership, Management, and Consulting:
…In the areas of Pharmacology, ADME, Clinical Pharmacology, Safety/Toxicology, CMC, API Management, Formulation, Analytical, Fill & Finish, Clinical Study Design, Regulatory Compliance, and Outsourcing Management
On This Page:
Leadership, Management, & Consulting in:
IDSC is a fully integrated drug discovery and development solution. As such, within the preclinical development area our experts provide clients with the broad range of expertise and services needed to advance their drug candidates to IND. IDSC services in preclinical development span the fields of pharmacology, ADME, clinical pharmacology, drug safety/toxicology/veterinary pathology, chemical development/CMC/API management, regulatory compliance, clinical study design, and outsourcing management. There are many companies that provide expertise in one area of the process but few that offer our critical integration. The differentiating factor provided by IDSC is the ability to understand and coordinate each discipline (business and technical) to create an integrated plan that is aligned with the needs of the client. IDSC brings these resources together in a collaborative environment to implement an effective strategy from candidate identification to IND filing.
Because of the successful careers of our directors, IDSC's clients come to us for consulting, to fill gaps in their development team, and for fully integrated preclinical development collaborations. They value the depth of expertise that the IDSC team brings to their organization. We bring a big-pharma trained development team to our biotech clients.
In a fully integrated collaboration clients come to IDSC to utilize our development teams to help them advance their assets from clinical candidate to IND. This involves, for example, our client and our team proceeding through the five step process described below:
Slide Deck: Click here to view IDSC's slide deck entitled "Preclinical Development Plan Outlines: Therapeutic, Device, Diagnostic."
IDSC's clients come to us for both in vitro and in vivo pharmacology consulting services, across a wide range of therapeutic areas, and for discovery of both small molecules and biologics.
IDSC offers its clients complete ADME consulting services and PK/PD/TK modeling services for both small molecules and biologics.
IDSC's clients come to us for consulting services in safety pharmacology, preclinical toxicology, and pathology, in all relevent clinical species, with expertise in most of the major therapeutic areas and for both small molecules and biologics.
IDSC brings it's clients complete CMC regulatory support covering all areas of chemistry, biologics, formulation, analytical, and fill & finish... from preclinical to launch.
IDSC's clients come to us for expert API management and process development consulting services for both small molecules and biologics, and our expertise spans preclinical to launch.
IDSC brings career analytical expertise to our clients including consulting services in analytical method development & optimization and troublshooting to support development programs in small molecules and biologics again spanning preclinical to launch.
IDSC brings career formulation expertise to our clients to optimize pharmaceutical properties of both small molecules and biologics again spanning preclinical to launch.
IDSC's clients come to our clinical team to ensure alignment between their preclinical program and the desired clinical plan. IDSC supports our clients with clinicians from multiple therapeutic areas.
Navigating the regulatory pathway can be a challenge for companies. That is why our clients come to IDSC. We are their gateway to the FDA and the EMEA, we guide them through the regulatory pathway, prepare them for FDA meetings prepare their documentation, and manage their data and information.
‡IDSC does not have laboratories. Laboratory services are exclusively outsourced, and ISDC manages our clients' outsourcing efforts.