Services

Bridging Compliance and Digital Transformation

From QMS implementation to audit-ready data infrastructure, we help life sciences companies meet regulatory requirements while scaling with confidence.

Main Services

Quality

  •  Gap Analysis
  •  Quality Management Systems Build and Implementation
  •  Internal Audits / Supplier Audits / Mock Audits
  •  Design Controls / Design History File
  •  Design Verification and Validation
  •  Reliability / Human Factors
  •  Software Lifecycle Development
  •  Risk Management
  •  Complaint Handling
  •  CAPA processes
  •  Management Reviews
  •  ISO 13485, ISO 9001, ISO 14971, IEC 62304, 21 CFR 820, 21 CFR 210/211, EU MDR 2017/745

Regulatory

  •  Regulatory Submissions
  •  FDA QSub
  •  FDA 483 / Warning Letters Remediations
  •  EU Technical Documentation /Clinical Evaluation Plan (CEP) Clinical Evaluation Report (CER)
  •  Production / Environments
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cGxP

  •  Pre-Clinical / Clinical / Early Commercial
  •  Validation IQ / OQ / PQ
  •  Process Flow / Optimization
  •  QC GLP Test and Release
  •  Peptides / Small Molecules / Biologics
  •  Medical Devices / Combination Products / In Vitro Diagnostics (IVDs)
  •  Cellular and Tissue products (HCT/P)

Data & IT

  •  Software Lifecycle Development and Validation
  •  Information Management Systems
  •  Data Readiness: Curation, Labeling and Governance
  •  Cybersecurity
  •  cGxP Cloud Architecture (AWS / Azure)
  • SOC 2 / HIPAA / GDPR Controls Implementation and Readiness