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Integral BioSystems
Development Services Overview

We offer a systematic, step-wise development plan.

The Factors of a Successful Project Plan.
The success of a project is dependent on the following factors:
  1. “The Big Picture” ---Strategic Project Planning, Risk/Benefit Analysis of Strategies

  2. “The Tactical Details”---Detailed Project Lay-out, with all essential linked activities

Failure in either one of the two basic categories can result in loss of time and money for the company. While 50,000 feet strategy development is done as part of the company’s goals development objectives, Integral BioSystems can offer key input into the risk/benefit analyses of each strategic approach to assist the development team. This could range from the budgetary requirements, as well as regulatory considerations to get the drug from the laboratory to its validation in the clinic. The second category flows naturally from the first. Integral BioSystems develops a detailed plan to take the concept from the laboratory to the clinic. Once the strategy is in place, the tactical plan is of critical importance, since it results from the critical analysis of the place in the overall project plan of each detail, resulting in an absolute minimum of time wasted.

Project Planning Steps.
In order to develop the detailed project plan and the proposal, Integral BioSystems will meet with your development team to discuss the scope of the project and its objectives. This occurs after both companies have signed a Confidential Disclosure Agreement (CDA). At this point, data is evaluated, then challenges and proposed clinical indication and route of administration of the drug are discussed. In this regard, we can offer expert consulting on the process, or a full-blown tactical plan of the program. The plan thus prepared is then evaluated for cost.

Program Synopsis.
The program we offer with our drug development program consists of pre-formulation, formulation development, analytical method development, preparation of toxicological materials, then development of the formulation into formats that will be applicable to clinical dosing in the route of administration. Integral BioSystems scientists will scale-up the formulation preparation and technology transfer to an aseptic, GMP manufacturing site for final packaging of CTM. We assist in each step, from project management and consulting, integrated to our development services.

 
 
 
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