About Us
BioTechLogic, Inc. is a biopharmaceutical manufacturing and CMC consulting firm with strategic and practical/hands-on experience that helps clients bring their products to market quickly and successfully by augmenting and optimizing an organization's technical, manufacturing, analytical, and regulatory resources.
"A highly professional bioprocess consultancy organization focused on customer needs."
- European Client
Our technical expertise resides in a wide range of biological and oligonucleotide products including recombinant proteins, vaccines and blood products.
Through the combined expertise and knowledge of our staff, we have developed proven methodologies and approaches for providing reliable and dependable services in the following areas:
- Process Development and Quality by Design (QbD) including:
- Design of Experiments (DOE)
- Development Reports
- Critical Process Parameter Evaluation
- Technology Implementation, Transfer and Scale-up
- On-site third party contract manufacturing support
- BioAnalytical Services
- Process Validation
- Biotechnology Project Management
- Quality Assurance
- Regulatory Submissions
- PAI Inspection Readiness (FDA Pre-Approval Inspection Readiness)
As workloads exceed resource capacity due to accelerated commercialization timelines and/or when objective third party input is required to develop strategies or solve problems, BioTechLogic will provide the technical skills and personnel to fill these needs.