Drug Development Services
In working together with our clients DDP sets up an integrated plan for the entire project. This plan contains both the top-line and the detailed planning of activities. Naturally, all implemented activities will be closely monitored. The critical development path will be identified in order to assess the impact of all critical development factors on the overall timing of the project. As an example, the following stages can be identified:
preclinical, clinical, and chemistry, manufacturing & control (CM&C) data
- In the first stage, DDP evaluates the preclinical, clinical, and chemistry, manufacturing & control (CM&C) data that are available and identifies gaps in the available data, formulates actions, and records those in a formal drug development plan or in sub-plans for the individual disciplines, depending on what is needed.
regulatory consultancy
- Based on this, DDP can formulate a more detailed regulatory strategy for both the EU/US and other territories and design and coordinate a regulatory consultancy round with the relevant regulatory authorities. The assigned work, as specified for this first stage, will largely be performed by a single contact person of DDP, who will involve other key people of DDP. All actions will however always be performed in close collaboration with the client.
clinical drug development services plan
- DDP will draft a clinical development plan, in which the key strategic studies for registration and marketing purposes will be outlined. In addition, DDP will liaise with key opinion leaders in the field to validate the clinical development plan and to obtain sufficient endorsement from the field for the clinical studies.
- In the meantime, DDP will identify in-house personnel to form the drug development team, integrated with key staff members of their client.
- Parallel to the first stage of the project, the client can already invoke the CM&C expertise of DDP at any point in time to assist in the coordination of drug-product- and drug-substance-related affairs.
A detailed cost estimate is provided following discussions on the expected input in the drug development process.
(c) 2008, Amsterdam
Antiviral Research
1105 BM Amsterdam
The Netherlands
Phone: +31 (0)20 314 9300
Fax: +31 (0)20 314 9399
secretariat@iatec.comMore information about IATEC at
www.iatec.com