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Services
ABS Inc. USA – A Strategic
Consulting Consortium with extensive experience of professional
consultants in Biopharma and Pharmaceutical, Biotechnology, Medical
device and Diagnostic Industries.
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:
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FDA’s 483s, Warning Letter /Consent Decree Remediation
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cGMP manufacturing
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Quality Control
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Quality Assurance &
Compliance
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Investigations for Drug
Substances & Drug Products : Deviations, Market Complaints,
Root Cause Analysis
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Laboratory Investigations
and OOS
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Change Control
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Remediation Assistance
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Post Market Surveillance
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Clinical Compliance
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Validation Engineering
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Manufacturing Engineering
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Product Development & Spec.
Setting
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Data Audits
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3rd party oversight for
Regulatory Agencies.
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Lean Six Sigma
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Biostatistics (SAS/JMP)
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IT Solutions (21 CFR Part
11)
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Equipment
/Facility/Utility/Laboratory Equipment Validation
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Technology Transfer
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Certified Project Management
Consultants
Regulatory:
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Regulatory Submissions (CMC
& Clinical Data): Experts 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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