Services | QualyInc – Pharmaceutical GMP Consultants

Expertise Tailored for Pharmaceutical Excellence

We support API sites, sterile formulation lines, cleanroom facilities, and testing labs through full lifecycle GxP compliance services.

01 / GAP-ANALYSIS

GMP Gap Analysis & Mock Audits

Identify compliance gaps before an auditor does.

Detailed audit checklist and facility verification reports
Document control trials and analytical log reconciliation
Personnel posture and sanitization behavior audits

Detailed Deliverables

GMP Gap Analysis & Mock Audits

02 / AUDIT-READINESS

Audit Readiness Preparation

Prepare your teams and documentation for any regulatory inspection.

SME training on handling regulatory interviewer questions
Defense strategies for sterile process steps and HVAC stability
Ready-to-present documentation portfolios

Detailed Deliverables

Audit Readiness Preparation

03 / AUDIT-RESPONSE

Audit Response & FDA Remediation

Expert FDA 483 / Warning Letter CAPA and closure support.

Warning Letter responses and technical justifications
Root-cause investigations for OOS/OOT and contamination events
Third-party oversight and CAPA execution tracking

Detailed Deliverables

Audit Response & FDA Remediation

04 / CONSULTING-SERVICES

General Pharma Consulting Services

Embedded GxP advisory engagements for complex projects.

Cleanroom structural design review and flow layouts
Risk assessments for HVAC validation and water loops
Mock inspections for laboratory instrument networks

Detailed Deliverables

General Pharma Consulting Services

05 / QMS-DEVELOPMENT

QMS Development & Strengthening

Build or upgrade your Quality Management System from the ground up.

SOP optimization and deviation control systems
Laboratory Data Integrity controls and access matrix structures
CAPA tracking protocols

Detailed Deliverables

QMS Development & Strengthening

06 / PROCESS-VALIDATION

Process Validation & Support

IQ/OQ/PQ lifecycle studies and Validation Master Plans.

Complete IQ, OQ, and PQ documents
Cleaning validation residue limit assessments
Computer Systems Validation (CSV) protocols

Detailed Deliverables

Process Validation & Support

07 / TRAINING

Corporate GMP Training

Structured GMP hygiene and aseptic technique training programs.

Practical training on sterile gowns and cleanroom entry
Data integrity logs and GDP behavior principles
Microbiology lab management guidelines

Detailed Deliverables

Corporate GMP Training