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| Home > What We Do |
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| Bio-Analytical Services |
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Karmic offers a full suite of Bio-Analytical services through strategic partnerships with 3 state-of-the-art
EU-MHRA/US-FDA audited Bio-analytical labs for BA/BE and Early Phase studies in India. We have access to a
total capacity of 160+ Beds and state-of-the-art equipment (LCMS, GCMS, HPLC) and 21 CFR Part 11 compliant
softwares (SAS, Kinetica, Analyst, MedDRA, WHO DD). We further have access to a database of 6000+ healthy male
volunteers, 1000+ healthy female volunteers, 500+ menopausal women and 250+ HIV patients.
We have a strong regulatory team to handle ANDA Filings, e CTD submissions, DGCI and IRB/IEC approvals and our
partner labs have experience in handling regulatory inspections from EU-MHRA, US-FDA, ANVISA, MOH (Israel),
Indian DCGI etc. We further support a well-defined library of validated methods and over 50 SOPs covering all
aspects of bio-analytical and instrumentation operations.
Our services include:
- Bio-Availability Studies
- Bio-Equivalence Studies
- Food Effect BA/BE Studies
- Drug Interaction Studies
- Bio-Analytical Method Development
- Bio-Analytical Method Transfer
- Bio-Analytical Method Validation
- Bio-Analytical Sample Analysis
- Statistics Support for Bio-Analytical Studies
- Pharmacokinetic Support
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| Featured Case Study |
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| Karmic currently supports a Top 5 Global Pharmaceutical giant for data management across 15+ studies in multiple therapeutic areas over 14+ geographies across the globe |
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