Services
Services
Embedded Files
Quality Management Systems (QMS)
QMS design, implementation, and optimization
Gap assessments and remediation plans
SOP development and harmonization
Data integrity program development
eQMS
Audits & Inspection Readiness
Internal audits (GMP, GDP, GLP)
Supplier audits and qualification
Mock regulatory inspections
Audit response
CAPA support
Regulatory Affairs Support
Regulatory strategy
Technical documentation review
Submission readiness support
Risk management and lifecycle compliance
Registration support
Training & Capability Building
GxP training
Inspection readiness workshops
QMS fundamentals
Leadership coaching for QA/RA functions
How we work
How we work
Step 1 — Discovery
We understand your goals, challenges, and timelines.
Step 2 — Assessment
We perform a targeted review of your systems, processes, and risks.
Step 3 — Action Plan
You receive a clear, prioritized roadmap with practical recommendations.
Step 4 — Implementation Support
We guide your team through execution, training, and documentation.
Step 5 — Sustain & Strengthen
We help you maintain compliance and stay inspection‑ready.
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