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About us:
ABS Inc. USA
A Strategic Consulting Consortium with extensive experience of
professional consultants in Biopharma and Pharmaceutical,
Biotechnology, Medical device and Diagnostic Industries.
ABS Inc. USAs 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:
FDAs 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
Regulatory:
Regulatory
Submissions (CMC & Clinical Data): Experts in
INDs/eBLA/eCTDs/NDAs/ANDAs for Biologics (Vaccines,
Therapeutic Proteins) & Pharmaceuticals INDs/ANDAs
Data
Integrity/Audit/Review as 3rd Party for FDA/EMA/WHO submissions
Support
clients with our consultants
Biosimilars/Biogenerics/Follow-on Biologics (Unique Experts):
Our
consultants launched Biosimilars from R&D to Product Commercial
Launch
Regulatory writing & submissions
Cell
Bank/Vaccine Seed Bank Overarching from Current to Enhanced State as
per Regulatory Requirements.
Expertise
Our consultants have led the successful remediation of multiple CAPA
initiatives and Quality related compliances (Investigation closure)
and driving a backlog of CAPAs to completion through rigorous
investigation and timely completion of the CAPA report. Our auditors
helped our clients to develop and deploy robust internal audit
programs that help assure successful regulatory, quality and
compliance audits. They are adept at creating and implementing audit
programs, from the audit policy, to the master audit schedule, and
on to execution of audits and resolution of audit findings.
Our experts also bring value to our clients by bringing Process
Optimization, improved efficiencies and operational excellence with
Lean Six Sigma Certification and intensive statistical
methodologies.
Partnership
Whether your organization is in need of occasional support from an
experienced industry professional or is looking to ramp up for key
projects, ABS Inc. USA is ready to deliver the expert talent you
need. We invite you to learn more about our solutions.
Our Value Proposition: For partnering clients, we send our expert
consultants with > 10-20-30-40 years of global biopharmaceutical
experience in all the areas of specialization. We have unique
business model that focuses on senior consulting consortium. Our
client partners get highly competent, skilled, and experienced
professionals in a timely manner cost effectively. Since it is
managed by senior consultants, we value our clients needs and
accordingly our skilled team will only recruit technically
qualified people. This will avoid clients time to interview and
recruit consultants and contractors. We conduct background checks
and collect references and establish contracts. ABS Inc. USA has Dun
& Brad accreditation and established in 2001 in NJ with long
tracking history. This is also minority Women owned company and the
most admired partner to carry out business.
The value that we offer to our consultants is that ABS Inc. USA will
issue W2s, 1099s and independent contracts with terms that align our
client needs and objectives. We offer the best benefits to our
consultants.
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