ABSINCGROUP

Our Value Proposition: Science & Technology, champ,Business and Technology Management with Operational Excellence and Continuous Improvement. Biologics (Vaccines, Cell & Gene Therapy, Therapeutic Proteins & Monoclonal Antibodies)/Medical Devices/Combination Products Strategic Senior Expert Consultants with Hands-On Experience with Operational Excellence in Process, Analytical, Formulation, Technology Transfer, Quality, Compliance and Regulatory ? Strategic and operational management with lean cost-effective solutions ? Bring integrated solid strong science and business management leadership tools and techniques for CMO and the Company ? Project Management and Product Management ? Take accountability and responsibility on your behalf ? Transparent and confidential communication ? Maintain highly professional ethics, integrity, intensity, and innovation ? Providing company and CMO quality, QC Testing, and GMP manufacturing staff training on o Contamination Control (routine problem in biologics GMP manufacturing and QC Microbiology and Testing Laboratories) o Continuous improvement using Operational Excellence and Six Sigma Black belt methodology and training ? Excellent senior strategic and tactical consulting team with multi-tasking, analytical, organizational and leadership skills. As a global expert in Vaccines Quality Management Systems, we offer oversight both Internal and CMO (external) Quality (QA-QC), Data Integrity & Reliability (ALCOA & ALCOA Plus), Compliance (audits, gap assessment, 483s, Warning Letter, and Consent Decree and proactive remediation and Regulatory (documentation, 3rd party FDA batch witness and batch release, review Annual Reports, Batch records, Validation Protocols, and Reports, Clinical Protocols and Reports and CMC and eBLA/eCTDs). Lean Six Sigma Continuous Improvements in process, MST, Analytical methods, Technical and Quality Operations. Regulatory Filings (IND/NDA/eBLA/eCTD). Biologics Site audits, gap assessment & remediation

网站

https://www.absincgroup.com

ABSINCGROUP的外部链接

所属行业

生物技术

规模

51-200 人

总部

West Orange，New Jersey

类型

私人持股

创立

2010

领域

Quality Management Systems、Tech Operation、Strategy to develop research to launch biologics、Our quality systems drive our preclinical, clinical, and commercial activities from development to full assay validation, compliant with ICH, FDA and EMA.、Business Development, Financial Due Diligence, COGS, P&L, Budget estimation、Virology, Vector Construction, Molecular Biology, Cell Biology, Biochemistry, Analytical Chemistry、Audit biopharma sites, Gap assessment and remediation cost effectively、I Our Assay development, Validation, Technology Transfer, QC data audits for Integrity II Vaccine Characterization Assays: III. Adjuvants: Lipid Nano Particle Analysis and testing IV Microbiology and Sterility Assays: ? Endotoxin ? Sterility ? Bioburden ? Adventitious Agents (Mycoplasma, HIV, Hep A-C, BSE etc.,). ? Rapid Identity Tests (qPCR and Serological) ? Pathogen Identification and validation ? Data review for integrity V Stability Program ? Review Protocols and Reports ? Stability Program development ? Closely monitoring timely testing and data analysis ? Ensure out of compliance and avoid FDA citations 和Quality & Compliance: ? FDA’s 483s, Warning Letter /Consent Decree Remediation ? cGMP manufacturing ? Quality Control ? Quality Assurance & Compliance ? Investigations for Drug Substances & Drug Products : Deviations, Market Complaints, Root Cause Analysis ? Laboratory Investigations and OOS ? Change Control ? Remediation Assistance ? Post Market Surveillance ? Clinical Compliance ? Validation Engineering ? Manufacturing Engineering ? Product Development & Spec. Setting ? Data Audits ? 3rd party oversight for Regulatory Agencies. ? Lean Six Sigma ? Biostatistics (SAS/JMP) ? IT Solutions (21 CFR Part 11) ? Equipment /Facility/Utility/Laboratory Equipment Validation ? Technology Transfer ? Certified Project Management Consultants