Our services

Compliance consulting, end to end.

From validation strategy and qualification protocols to facility build-out project management, CQMP delivers rigorous, risk-based compliance services tailored to pharmaceutical, biotech, and medical device organizations.

What we deliver

Select a service to explore scope, deliverables, and applicable regulations.

Validation Planning & Strategy

Start right. Stay compliant.

A strong compliance program begins with a clear, well-documented strategy. We work with your team to develop a Validation Master Plan that defines scope, responsibilities, risk classification, and documentation standards — aligned with your regulatory environment from day one.

Key Deliverables

  • Validation Master Plan (VMP)
  • System inventory and risk classification
  • Compliance lifecycle roadmap
  • Regulatory gap analysis

Applicable Regulations

FDA 21 CFR Part 11EU Annex 11GAMP 5

Industries

PharmaceuticalBiotechnologyMedical DeviceClinical Research

How we work

A proven process. Every time.

01

Discovery

We start by understanding your systems, your team, and your regulatory environment.

02

Strategy

We build a tailored compliance plan with clear scope, timelines, and deliverables.

03

Execution

Our team authors protocols, manages projects, and documents everything to inspection standard.

04

Review & Approval

We support your internal review process and ensure all documentation is complete and signed.

05

Ongoing Support

Compliance doesn't end at approval. We stay available for periodic reviews and change control.

Industries we serve

Built for regulated industries.

Pharmaceutical

Drug manufacturing, QC labs, and clinical operations.

Biotechnology

Bioprocess systems, LIMS, and research platforms.

Medical Device

Design control, production, and post-market systems.

Clinical Research

EDC, CTMS, and trial management platforms.

Not sure where to start?

We'll help you assess your current state and build a roadmap that fits your timeline and budget.