MEETING YOUR GLOBAL COMPLIANCE NEEDS
Auditing
cGMP Consulting specializes in providing global, comprehensive audit services to help you meet the applicable regulations and achieve compliance. Our team is dedicated to assisting you in preparing for a governing body audit, conducting audits, and advising on audit observations through remediations.
We have provided auditing and regulatory response assistance to organizations operating in various industries, including:
- Pharmaceuticals
- Medical Devices
- Drug Distributors
- Dietary Supplements
- Human Food
- Animal Food
Quality Audits
Our Audit services are always tailored to meet your needs. However, most requests typically fall into the following categories:
- Internal GMP Self-Inspections
- Pre-Approval Inspection Readiness
- Supplier Qualification Audits
- Due Diligence Assessments
- Routine Supplier Audits
- GMP Gap Assessments
Our experienced auditors have successfully conducted audits for numerous clients across diverse industries, including pharmaceuticals, distribution, third party manufacturers, dietary supplements, and dental products. Our auditors have worked with overseas manufacturers to prepare for Pre-Approval Inspections (PAI) and FDA audits.
Post-Audit
If your organization is confronted with any of the following:
- FDA 483
- Warning Letter
- Consent Decree
- Supplier Audit Observations
Responding can be an intimidating endeavor. Our team of executive consultants have the expertise necessary to craft, with you, a thorough and timely response for your organization to potentially prevent further escalation. Once the response is delivered, our team of engineers can also provide regulatory assistance for remediation efforts. Explore how we can fortify your remediation initiatives by visiting: Quality System Development & Support
Quality Audits
Our Audit services are always tailored to meet your needs. However, most requests typically fall into the following categories:
- Internal GMP Self-Assessment
- Pre-Approval Inspection Readiness
- Supplier Qualification Audits / Due Diligence Assessments
- Routine Supplier Audits
- GMP Gap Assessments
Our experienced auditors have successfully conducted audits for numerous clients across diverse industries, including pharmaceuticals, distribution, third party manufacturers, dietary supplements, and dental products. Our auditors have worked with overseas manufacturers to prepare for Pre-Approval Inspections (PAI) and FDA audits.
Post-Audit
If your organization is confronted with any of the following:
- FDA 483
- Warning Letter
- Consent Decree
- Supplier Audit Observations
Responding can be an intimidating endeavor. Our team of executive consultants have the expertise necessary to craft, with you, a thorough and timely response for your organization to potentially prevent further escalation. Once the response is delivered, our team of engineers can also provide regulatory assistance for remediation efforts. Explore how we can fortify your remediation initiatives by visiting: Quality System Development & Support
