BioTechLogic, Inc. Details
BioTechLogic, Inc.
Company Profile: BioTechLogic, Inc. provides biopharmaceutical regulatory and manufacturing consulting services with strategic and hands-on experience to assist clients in bringing their products to market quickly and successfully by augmenting and optimizing their organization’s resources. Our success is due to our ability to serve as the technical, manufacturing, quality and regulatory expert for strategic consultation, or be the hands-on resource that drives and executes the plan.
Key Products: Our team of experts provides the following services: * Process Development: Development Reports, Design of Experiments (DOE), Technology Implementation, Transfer and Scale-up, Comparability, Troubleshooting, Technology and Facility Evaluations * Manufacturing: On-Site Third Party Contract Manufacturing Support, Statistical Process Controls, Supply Assurance * Process Validation: Strategy, Critical Process Parameter Evaluation, Validation Protocols and Reports, Support Validations (Resin Re-Use, Membrane Re-Use, Hold times, Loading Studies, etc.) * BioAnalytical Services: Strategy, Validation Protocols and Reports, Hands-On Lab Support, Expert Review, Analytical Method Transfer, Third Party Contract Laboratory Support, Product Characterization * Quality Assurance: Audits, Mock PAI/PLI Audits, Global Pre-Approval Inspection Readiness and Remediation Programs, Quality Systems, On-Site Senior Management * Regulatory Submissions: Briefing Packages, Agency Responses, INDs/IMPDs, BLA/MAA, 510K, PMA, PAS or ROW Filings * Project Management: Project Plans and Schedules, Team Organization, Meeting Management, Action Item Tracking, Budget Tracking, Project Status Reporting, Risk Management * Supply Chain Management: Site Selection, Make vs. Buy, Due Diligence * Combination Products: Regulatory Strategy, Dossiers, CE Marking process
Website:
www.biotechlogic.com
