BioTechLogic, Inc. Services
Our success is due to our ability to serve as the technical expert and consultant, while also functioning as a hands-on resource that successfully drives and executes your plan. We define the path, focus the resources, and drive the process to meet every milestone.
We offer 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
- For more on our expertise in this area, see our Synthesis, Fermentation and Cell Culture Processes experience, our Fill/Finish experience, our PEGylation Technology experience, and our Purification experience.
- BioAnalytical Services
- For more on our expertise in this area, see our BioAnalytical Development experience
- Process Validation
- Quality Assurance
- Regulatory Submissions
- Inspection Readiness (FDA Pre-Approval Inspection Readiness)
- For more on our expertise in this area, see our PAI Inspection Readiness experience
- Facility/Process Evaluations
- Due Diligence
- Make vs. Buy decisions
- Technology evaluations