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ABS
Inc. USA – A Strategic Consulting Consortium with extensive
experience of professional consultants in Biopharma and
Pharmaceutical, Biotechnology, Medical device and Diagnostic
Industries.
Mission:
Our mission is to provide top notch World class consultants and
technical experts to our clients
companies
and partnering clients.
ABS Inc. USA’s quality compliance professionals assist our clients
with Quality, Compliance, Regulatory Filing (CMC, Pre-Clinical and
Clinical submissions for ANDAs- NDAs, eBLAs, eCTDs), data review and
auditing and cGMP Manufacturing, Validations and QC analytical
Testing and Quality Operations Management Systems in a variety of
areas. Our consultants serve as subject matter expert and team
leaders, project managers as well as providing hands-on tactical and
strategic support.
Areas of
Expertise:
Quality Systems, Compliance, cGMP, Aseptic Manufacturing,
Validations, Regulatory, Analytical and QC, Data audits and
Regulatory Submissions (CMC & Clinical Data).
Consultants Focus Areas:
Quality & Compliance:
Regulatory:
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Regulatory Submissions (CMC
& Clinical Data): Expert in
INDs/eBLA/eCTDs/NDAs/ANDAs for Biologics (Vaccines, Therapeutic Proteins)
&
Pharmaceuticals INDs/ANDAs
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Data Integrity/Audit/Review
as 3rd Party for FDA/EMA/WHO submissions
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Support clients with our
consultants
Biosimilars/Biogenerics/Follow-on Biologics (Unique Experts):
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Our consultants launched
Biosimilars from R&D to Product Commercial Launch
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Regulatory writing &
submissions
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Cell Bank/Vaccine Seed Bank
Overarching from Current to Enhanced State as per
Regulatory Requirements.
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Leadership