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:

Pharmacology

ADME

Safety/Toxicology

CMC

API Mgmt. & Process Dev.

Analytical

Formulation

Clinical Program Design & Strategy Supporting Preclinical Development

Regulatory Compliance

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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:

 

  1. Gap analysis:  identification of additional experiments and other actions needed to gather sufficient information to submit an IND.  The output of the Gap analysis will be a document that identifies critical activities needed to progress to IND submission.
  2. Development Plan: design, timelines (e.g. Gantt Chart), and budget for conducting necessary studies.  This plan will also outline a recommendation (for or against) conducting a pre-IND meeting with FDA and whether the pre-IND meeting should be "early" or "late" in the preclinical development process.  The plan may also include a detailed Regulatory Strategic Plan.  The output of the development plan is a roadmap document to reach IND preparation and submission.
  3. Implementation: contracting and conduct of necessary preclinical studies, engaging contract manufacturers or contract research organizations (as needed), as well as support for review of study reports.
  4. Pre-IND Meeting:  should a pre-IND meeting be needed, organize, prepare the client for, and attend the pre-IND meeting with the FDA.
  5. IND preparation/submission: authoring of IND documents (i.e. preclinical summaries, CMC documentation, investigator's brochure, clinical protocol, investigational plan etc.) and submission of IND to FDA.

 

Slide Deck:  Click here to view IDSC's slide deck entitled "Preclinical Development Plan Outlines:  Therapeutic, Device, Diagnostic."

Functional Line Discipline Consulting Services:

Pharmacology

 

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.

 

Click here to go to IDSC's pharmacology consulting services page. 

 

ADME & PK/PD/TK Modeling

 

IDSC offers its clients complete ADME consulting services and PK/PD/TK modeling services for both small molecules and biologics.

 

Click here to go to IDSC's ADME & PK/PD/TK modeling page. 

 

Safety/Toxicology 

 

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.

 

Click here to go to IDSC's Safety/Toxicology page.

 

CMC

 

IDSC brings it's clients complete CMC regulatory support covering all areas of chemistry, biologics, formulation, analytical, and fill & finish... from preclinical to launch.

 

Click here to go to IDSC's preclinical CMC regulatory page.

 

API Management & Process Development 

 

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.

 

Click here to go to IDSC's preclinical API management page.

 

Analytical 

 

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.

 

Click here to go to IDSC's analytical page. 

 

Formulation 

 

IDSC brings career formulation expertise to our clients to optimize pharmaceutical properties of both small molecules and biologics again spanning preclinical to launch.

 

Click here to go to IDSC's Formulation page. 

 

Clinical Program Design & Strategy Supporting Preclinical Development

 

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.

 

Click here to go to IDSC's clinical program & strategy (supporting preclinical) page.

 

Regulatory Compliance

 

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.

 

Click here to go to our Regulatory page.

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‡IDSC does not have laboratories.  Laboratory services are exclusively outsourced, and ISDC manages our clients' outsourcing efforts.

IDSC's preclinical development project IDSC's clients come to us to fill gaps in their project teams in addition to fully integrated collaborations where IDSC supplies our client with a majority of the project team or an entire project team.
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