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"Really impressive and very thorough.  It makes sense that pharma and device companies would just hire you rather than wait for the FDA."

- Former ISO inspector
Philadelphia, Pennsylvania

Mock FDA Audits and Risk Assessments

Prove your compliance status without the hassle

 

 

Cerulean's mock FDA inspection (GMP, GLP and Part 11) service has been developed specifically for small to midsized businesses, single site divisions, and supplier or vendor due diligence.  We have a  61+ page questionnaire with over 400 detailed questions constantly updated to incorporate current regulatory expectations.

Depending on your goals, we can set the inspection as an overall gap analysis of your incorporation of compliance best practices into your operations, or we can do this as a QSIT-based audit, replicating for you as if an FDA inspector knocked on your door.

 

You Get:

1.  Objective assessment of compliance level and evidence

2.  Detailed gap analysis with straightforward explanations

3.  Prioritized set of recommendations tailored to your business

4.  List of records to maintain to demonstrate proof of compliance

5.  Appendices that offer sample "fixes" you can use or expand upon

6.  Additional steps to consider implementing over the next 18-36 months

7.  Independent audit certificate

8.  Demonstrated proof of continual improvement and intent to comply

9.  Staff coaching on inspections, types of questions and how to respond

10.  Thirty days of free post-audit support, advice and help

11. One full year (12 months) of free help preparing for any regulatory inspection or third-party audit

 

You Can Also Use This Mock FDA Audit For:

1.  Mock PAI (pre-approval inspection)

2.  A company-wide risk assessment

3.  The framework for your own future self audits

4.  Auditing individual internal business functions

5.  IT department, CMO, CRO or other contracted service reviews

6.  Operational assessments with realistic tactics for improvement

7.  Proof for prospective customers and partners of your compliance level

 

Our managing director brings his FDA compliance and auditing experience to your benefit, reviewing your facility, interviewing your personnel, and examining your records, systems and controls.

You receive the detailed report and certificate within 30-45 days, including an executive summary and the original observations.

And, like all other specialized services, as a Cerulean client you get a risk-free triple guarantee, including 12 months of free FDA inspection support.

 

Are you ready to prove your compliance is a competitive advantage?

Contact us today.  We offer a FREE ½ hour consultation to new clients.