Request a meeting with PVLMC representatives to develop a scope of work (SOW) for your project.  SOWs may include any of the following services related to the manufacturing of biologics / therapeutic proteins:

• Subject matter expert technical consulting for US FDA process validation stages 1, 2, and 3.   

• Regulatory compliance due diligence assessments and technical advisement.

• Research and development services related to technical transfer, critical quality attribute (CQA) evaluation, product evaluation and comparability, process characterization, and product stability.

• Clinical data and regulatory submission management.

• On-site seminars for any of our listed consulting trainings.