Expertise

Hands-on pharmaceutical Quality and Compliance support across laboratories, manufacturing, and Quality Systems.

01

Quality

Strengthening pharmaceutical quality systems and operational execution.

Quality Systems
QA / QC Laboratory Operations
OOS/OOT Investigations
CAPA & Deviation Management
Batch Record Review
Supplier Qualification
Analytical Method Validation & Transfer

02

Data Integrity

Reliable GMP decisions depend on reliable data. We assess and strengthen the systems, behaviors, and controls that keep regulated data trustworthy.

ALCOA+
Data Integrity Assessments
Audit Trail Governance
User Access Controls
Electronic Records & Signatures
Computerized Systems & Backup/Restore
Good Documentation Practices

ALCOA+ principles

Attributable · Legible · Contemporaneous · Original · Accurate · Complete · Consistent · Enduring · Available

03

Compliance Remediation

Turning regulatory and compliance gaps into sustainable corrective actions.

Compliance Gap Assessments
Regulatory Remediation
Quality System Remediation
CAPA Effectiveness
Investigation Remediation
Remediation Governance

04

Inspection Readiness

Inspections should validate the strength of a Quality System, not expose weaknesses that could have been found earlier.

FDA Inspection Readiness
Mock Regulatory Inspections
Front & Back Room Preparation
SME Preparation
Data Integrity Readiness
Investigation & CAPA Review
Executive Debriefing

Environments Supported

Pharmaceutical Manufacturing
Sterile Manufacturing
Oral Solid Dosage
QC / Analytical Laboratories
Contract Manufacturing & Laboratories
Packaging Operations

Regulatory Frameworks

FDA 21 CFR Parts 210 and 211
21 CFR Part 11 & EU Annex 11
FDA Data Integrity Guidance
ICH Q7 / Q9(R1) / Q10
EU GMP
USP requirements

Facing a Quality or Compliance Challenge?

Let’s discuss your organization’s Quality, Data Integrity, inspection readiness, or remediation needs.

Discuss Your Compliance Needs