Pharmaceutical R&D

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The Technical Affairs group with the Pharmaceutical R&D department at the Merck Frosst Centre for Therapeutic Research ensures the accuracy and completeness of all documentation prepared by the department. This includes the information related to any regulatory submissions (e.g., Investigational New Drugs - INDs, IND Amendments, New Drug Applications - NDAs, etc. ), the manufacturing and packaging information, the clinical labeling information, as well as analytical data generated by the analytical laboratory.

The team has the opportunity to follow a new compound from Phase I trials to, in some cases, post-marketing trials.

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The Technical Affairs group also ensures that the correct batch, packaging components and equipment are in place, prior to a packaging operation for the clinical materials.

Finally, this group ensures that stability samples are stored in qualified, calibrated stability chambers, and that all samples are placed into and removed from these chambers at the correct intervals.