Process Development Manufacturing Management
Process Validation Process Equipment Design
Providing services to the Pharmaceutical and Biopharmaceutical Industries:
· Planning, technical input and review, procurement, and start-up/validation management for custom process equipment.
· Development and oversight of a program for process characterization for a late-stage clinical product.
· Technical input and review of downstream process development efforts for a recombinant protein.
· Management of process transfer from pharmaceutical company to Contract Manufacturing Organization (CMO).
· Oversight and review of Process Validation studies and reports for pharmaceutical product at a CMO.
· Preparation of Process Validation Master Plan and Process Validation Protocols for a late-stage Biopharmaceutical product.
· Preparation of Chemistry, Manufacturing, and Controls (CMC) sections in support of a Regulatory filing.
· Development of Validation policies and infrastructure for an established Biopharmaceutical Company.
· Preparation of Product Development guidelines for an established Biopharmaceutical Company.
· Assistance establishing development infrastructure and hiring key personnel for the Process Development function for a mid-sized Biopharmaceutical Company.
Mission & Values
PL Consulting strives to provide consulting services in its areas of proven excellence, offering clients a professional and accessible option for engineering and management expertise. Flexibility, timely response to requests, fair pricing, a knowledgeable industry network, and a broad spectrum of experience combine to provide effective solutions for clients. Our primary objective is making a positive contribution to our clients’ success.
Assignments in our areas of expertise can be accomplished effectively and efficiently for clients seeking external resources or capability. Depending on the nature of the assignment, we work independently, collaboratively with internal resources, and/or with additional external resources. Our flexibility, knowledge of the subject area, personalized approach, and lack of bureaucratic impediments make it easy to work with us.
PL Consulting is a Limited Liability Company, registered in Massachusetts.