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:
- BioAnalytical Services
- For more on our expertise in this area, see our BioAnalytical Development experience
- Project Management
- Highlight critical project issues and risks, and facilitate the development of mitigation action plans
- Track and report progress that will enable management at all levels to get a clear picture of project status, and upcoming activities and milestones
- Inspection Readiness (FDA Pre-Approval Inspection Readiness)
- For more on our expertise in this area, see our PAI Inspection Readiness experience
- 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.
- Process Validation
- Process Pre-Qualification
- Manufacturing Qualification
- Life Cycle Qualification
- Quality Assurance
- Regulatory Submissions
- FDA Briefing packages
- Module 2 (Quality Overall Summary)
- Module 3 (CMC) CTD regulatory submissions
- Facility/Process Evaluations
- Due Diligence
- Make vs. Buy decisions
- Technology evaluations
- Combination Products