At the early development of stage of a new product a deep, understanding of the general international regulatory viewpoint is vital. GMP, GLP and GCP quality systems, formulation, API manufacturing functions, pre-clinical research, in-vivo and in-vitro studies and an ability to integrate all of the above.
BioPlan has hands-on experience integrating all such activities and can provide your company with the advantage of cost and time saving in getting your product to the clinical trial stage and from there to market in respect to the necessary regulatory approvals.
This Service Includes, Amongst Other Things, the Topics:
EMA or FDA Approval
Pre-clinical regulatory strategies and regulatory plans
Animal in-vivo/in-vitro research studies.
Choosing together with you a reliable CRO company
Development of a GMP Quality system for the active ingredient
Development and recording of data within the GMP system for formulation
Manufacture GMP support at the clinical stage
Full Clinical management of monitoring in accordance with GCP standards
QP Batch Releases of clinical batches
Shelf-Life evaluation and clinical labeling expertise