In healthcare, documentation isn’t optional—it’s legal.

Agamin partners with pharma, biotech, and CROs to deploy Salesforce-based systems—built for compliance from day one across QMS, trials, pharmacovigilance, and commercial ops.

THE CHALLENGES

Life sciences demand more than generic platforms were built to handle.

Life sciences operate under strict regulatory demands—where compliance, traceability, and audit readiness are non-negotiable.
Gaps in QMS, clinical trials, or pharmacovigilance systems aren’t technical issues—they’re regulatory risks.
At the same time, commercial complexity is rising—from HCP engagement to market access and specialty workflows.
The organisations that succeed partner with teams that understand both—compliance and commercial—before building anything.
Healthcare Dashboard Mockup
WHAT AGAMIN BRINGS

Regulatory expertise and Salesforce capability, built for the life sciences operating environment.

1.

Heading: Quality & Regulatory Compliance

Salesforce-based QMS with Part 11-compliant e-signatures, audit trails, CAPA, deviations, change control, and SOP management—built by teams with real pharma QA experience.
1
2.

Regulatory Submission Management

End-to-end tracking for IND, NDA, BLA, and more—milestones, health authority correspondence, and submission-ready documentation in one system.
2
3.

Clinical Trial Operations

Site selection, investigator management, enrolment tracking, IRB workflows, and protocol compliance—delivered with real-time trial visibility.
3
4.

Pharmacovigilance

Adverse event intake, MedDRA coding, ICSR generation, and E2B(R3) submissions—backed by compliant, audit-ready workflows.
4
5.

Medical Affairs & Commercial

Scientific engagement, publications, grants, and HCP workflows—combined with market access, hub management, and patient support systems.
5

Key
Capabilities

  • FDA 21 CFR Part 11-compliant QMS — CAPA, deviation, change control, audit management
  • Regulatory submission tracking — IND, NDA, BLA, MAA milestone and correspondence management
  • Clinical trial site management — feasibility, investigator agreements, performance tracking
  • Patient enrolment — digital pre-screening, consent management, retention campaigns
  • EDC integration and protocol deviation workflow management
  • Pharmacovigilance — adverse event intake, MedDRA coding, ICSR, E2B(R3) submission
  • Medical affairs — scientific engagement, KOL management, publication tracking
  • Commercial — HCP engagement, formulary access, specialty pharmacy, hub enrolment
  • Salesforce Life Sciences Cloud, Service Cloud, and Experience Cloud implementation