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Home
Why Sraman
About Us
Network & Quality
Therapeutic Areas
Services
Regulatory Strategy & IND/IMPD Road-mapping
Preclinical Study Design & Cro Matchmaking
GLP Toxicology & Safety Pharmacology
DMPK/ADME & Bioanalytics
Chemistry, Manufacturing & Controls
Biologics & Vaccines
Medical Devices & Diagnostics
Program & Quality Oversight
Leadership
Contact Us
Get in Touch
Home
Why Sraman
About Us
Network & Quality
Therapeutic Areas
Services
Regulatory Strategy & IND/IMPD Road-mapping
Preclinical Study Design & Cro Matchmaking
GLP Toxicology & Safety Pharmacology
DMPK/ADME & Bioanalytics
Chemistry, Manufacturing & Controls
Biologics & Vaccines
Medical Devices & Diagnostics
Program & Quality Oversight
Leadership
Contact Us
Get in Touch
Program & Quality Oversight
Home
Service
Program & Quality Oversight
Program & Quality Oversight
GxP audits (GLP/GMP), data integrity, e-systems validation.
Risk-based monitoring; deviation/CAPA coaching; submission-ready data packs.
Typical Deliverables
1
Program governance manual with roles, cadence, and escalation tiers
2
Audit plan and qualification checklist (GLP/GMP/GCP alignment)
3
Data-integrity review report with traceability mapping
4
Deviation, CAPA, and change-control logbooks
5
Quarterly program dashboards (timelines, cost, quality metrics)
6
Final inspection readiness report and submission data-pack index
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Our Expertise
Regulatory Strategy & IND/IMPD Road-mapping
Preclinical Study Design & CRO Matchmaking
GLP Toxicology & Safety Pharmacology
DMPK/ADME & Bioanalytics
Chemistry, Manufacturing & Controls
Biologics & Vaccines (incl. NHP/Large Animal)
Medical Devices & Diagnostics
Home
Why Sraman
About Us
Network & Quality
Therapeutic Areas
Services
Regulatory Strategy & IND/IMPD Road-mapping
Preclinical Study Design & Cro Matchmaking
GLP Toxicology & Safety Pharmacology
DMPK/ADME & Bioanalytics
Chemistry, Manufacturing & Controls
Biologics & Vaccines
Medical Devices & Diagnostics
Program & Quality Oversight
Leadership
Contact Us
call: +91 999 519 9993
admin@sramanlifesciences.com
Darshan Nagar, Thiruvananthapuram