What We Do
We support manufacturers in preparing for GMP certification by developing and strengthening the systems required for sustained compliance. We work alongside your team to ensure you are fully prepared for third-party audits or possible regulatory review.
Our experts can also be onsite during audits to provide real-time support, helping field auditor questions, facilitate communication, and proactively address potential issues.
With cGMP Consulting, you approach certification with confidence, fully prepared and ready to succeed.
Why GMP Readiness Matters
Entering a GMP certification audit can lead to unexpected findings and delays when gaps are not visible from within your organization. Our team brings an objective, outside perspective along with established industry best practices to help identify and address what may be overlooked, ensuring a smoother and more efficient certification process.
We help you:
- Identify gaps before auditors do
- Put the right systems in place to meet regulatory expectations
- Reduce rework
- Move through certification process with ease and confidence
How We Support Your GMP Readiness
Assessment & Gap Identification
- GMP Gap Assessments
- Internal, External, and Supplier Audits
Audit Preparation & Response
- Audit Remediation
- Regulatory Response Support
Training & Quality Oversight
- GMP Training
- Quality Assurance Support
- Onsite Audit Support
System & Documentation Development
- QMS Development
- HACCP / FSMA Programs
- Technical Writing
- Electronic Document Management Systems (EDMS)
- Electronic Batch Records (EBR)
Operational & Facility Support
- New Facility Consultation
- Interim Management Support
- Project Management
Product & Compliance Review
- Ingredient & Label Review
Our Approach
1. Assess
We evaluate your current state against GMP expectations.
2. Build & Align
We recommend improvements or refinements of your systems, documentation, and processes.
3. Prepare
We lead the implementation of your remediation and training efforts to resolve the identified gaps.
4. Support Through Certification
We remain engaged throughout the process, with the option for onsite support, to ensure you are fully prepared for certification.
