Who We Are
Biopharma Consulting Solutions, LLC (BCS) is focused on providing flexible services and resources to businesses within Cell and Gene Therapy, Biologics, Vaccines, and Medical Device industries. BCS delivers accuracy and efficiency, with specialized knowledge and experience from start to finish.
At BCS, we pride ourselves on serving as an extension of your team. We believe that our deep and broad industry experience coupled with a collaborative and flexible approach, uniquely positions us to achieve project success. We understand the unique challenges faced by life science companies. By applying best practices and tailored solutions, we address your needs and deliver results to reach your goals.
We provide consulting and program management services for clinical and commercial manufacturing programs. Our team supports quality assurance, quality control, manufacturing, regulatory affairs, and supply chain for cell and gene therapy, biologics, vaccines and medical device programs.
Through our suite of services, we offer clients a one-stop-shop for program and project management, process development and manufacturing, quality, compliance, validation, technical writing, and virtual and on-site training.
Learn more about our services
Program and Project Management Consulting Services
⦁ Process Development
⦁ Manufacturing Operations
⦁ Quality Control and Analytics
⦁ Computer System Validation
⦁ Supply Chain
⦁ Quality Assurance
Process Development and Manufacturing Consulting Services
⦁ Vendor Evaluation and Selection
⦁ Facility Design and Qualification
⦁ Equipment Purchase and Qualification
⦁ New Product Introduction and Technology Transfer
⦁ Process Scale up / Optimization / Improvement
⦁ Operations Management
Quality, Compliance and Validation Consulting Services
⦁ Quality Management, Controls and Systems
⦁ QMS Gap Assessment
⦁ Inspection Readiness and Audit Support
⦁ Process and System Validation
⦁ Data Integrity
⦁ Root Cause Analysis
Engineering, Operations and Quality Technical Writing Consulting Services
⦁ Documentation Gap Assessment
⦁ Author, review and approval of Procedures, Batch Records, Work Instructions, Protocols and Reports
⦁ Regulatory Applications (IND, IMPD, BLA)
Virtual and On-site Training Consulting Services
⦁ Process Overview
⦁ On-job Training
⦁ Aseptic Qualification
⦁ Person In Plant
⦁ Quality Matrix
Get In Touch
Do feel free to contact us or just send in your queries in the form and we will respond to you as soon as possible.