ABS
ABS Inc. USA is a strategic consulting company with extensive experience in the biopharmaceutical, pharmaceutical, biotechnology, medical device, and diagnostic industries. They provide leadership in quality and compliance systems, regulatory filings, data review, and auditing, with a focus on achieving full regulatory compliance and operational excellence. Their team of experts offers tactical and strategic support across various areas including cGMP manufacturing, investigations, validation, and regulatory submissions. They also partner with global companies to launch innovative products and provide expert consulting services.
Industries
Nr. of Employees
medium (51-250)
ABS
West Orange, New Jersey, United States, North America
Services
Consulting to design and implement QMS, conduct internal and external audits, CAPA management, investigations and remediation for regulatory compliance.
Preparation and review of CMC and clinical regulatory submissions including INDs, NDAs/ANDAs, eCTD/eBLA and liaison support for regulatory agencies.
Validation engineering and qualification of equipment, facilities, utilities and laboratory instruments; development of site master validation plans.
Support for development, troubleshooting and implementation of analytical methods (HPLC, microbiology, EM, bioassays) and application of pharmacopeial methods.
Assistance with cGMP operations, aseptic manufacturing, filling line support, cleaning validation and manufacturing scale activities.
Independent audits of data integrity for clinical and CMC datasets and support for remediation for regulatory submission readiness.
Consulting to design and implement QMS, conduct internal and external audits, CAPA management, investigations and remediation for regulatory compliance.
Preparation and review of CMC and clinical regulatory submissions including INDs, NDAs/ANDAs, eCTD/eBLA and liaison support for regulatory agencies.
Validation engineering and qualification of equipment, facilities, utilities and laboratory instruments; development of site master validation plans.
Support for development, troubleshooting and implementation of analytical methods (HPLC, microbiology, EM, bioassays) and application of pharmacopeial methods.
Assistance with cGMP operations, aseptic manufacturing, filling line support, cleaning validation and manufacturing scale activities.
Independent audits of data integrity for clinical and CMC datasets and support for remediation for regulatory submission readiness.
Expertise Areas
- Quality systems and regulatory compliance
- cGMP and aseptic manufacturing
- Validation and qualification
- Regulatory submissions and regulatory affairs
Key Technologies
- HPLC
- Microbiology testing
- Electron microscopy
- Bioassays