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

Biotechnology
Consulting
Medical Device
Pharmaceutical
Biotechnology Research

Nr. of Employees

medium (51-250)

ABS

West Orange, New Jersey, United States, North America


Products

ABS Remote Survey

A remote marine and offshore survey service that allows clients to conduct eligible classification and statutory surveys remotely through digital documentation transfer and mobile-friendly environments.

Remote Survey

Web-based platform allowing clients to order eligible surveys remotely, including annual classification, company and ship audits, and statutory surveys.

ABS Subsea Services

A comprehensive suite of independent verification, certification, engineering analysis, risk, and sustainability solutions offered by the American Bureau of Shipping for the global subsea sector across the full project life cycle.

3D Model-Based Class

Engineering plan review and survey leveraging 3D models for an end-to-end project model and time savings for designers.

Rapid Response Damage Assessment (RRDA)

24/7 access to technical support for vessel casualties provided by a team of engineers, naval architects, and master mariners.

Rapid Response Damage Assessment

An organized team of engineers, naval architects, master mariners and support staff that respond 24/7 to ship related emergencies such as grounding and collision, focusing on changes occurring to hull strength, stability and pollution risk mitigation.

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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.

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Expertise Areas

  • Quality systems and regulatory compliance
  • cGMP and aseptic manufacturing
  • Validation and qualification
  • Regulatory submissions and regulatory affairs
  • Show More (6)

Key Technologies

  • HPLC
  • Microbiology testing
  • Electron microscopy
  • Bioassays
  • Show More (8)

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