We assure that your bioanalytical data have been generated with the least regulatory risk possible, on time and on budget.

The help you need, when you need it, from the experts who know how to get the job done.

Stubbs & Hensel can recruit the right people to manage your drug development project.

Bioanalytical Forensic Auditing

Are you a CRO with Form 483 issues or a warning letter from the FDA?
Are you a sponsor who has just learned that your CRO has received numerous Form 483 deficiencies or a FDA warning letter?
Need to know the regulatory risk associated with all the bioanalytical work performed for the new in-licensed compound?
Ready to submit an INDA or NDA but you are not sure of the regulatory risk associated with the bioanalytical portion of the filing?
Are you a CRO with a need to have an un-biased assessment of your capabilities?

Stubbs & Hensel can help!

Stubbs & Hensel perform many types of forensic auditing:

Form 483 Deficiencies or FDA Warning Letter

Stubbs & Hensel will meet with:
- Key management, scientific and quality staff to
  - investigate and understand the issues leading to the FDA action
  - form a scientifically based strategy with management and legal representation
- with the FDA on behalf of our client to create an FDA approved mitigation plan
Stubbs & Hensel will work with:
- CRO to mitigate regulatory issues according to the FDA approved mitigation plan
- Sponsors to execute the FDA approved mitigation plan
Stubbs & Hensel will provide:
- A regulatory risk mitigation plan
- Execution of mitigation plan with full report and documentation
Stubbs & Hensel will provide support to answer any FDA questions related to the bioanalytical portions of the submission

Risk Assessment of Regulatory Submission

Stubbs & Hensel will review:
- All analytical validation, cross-validation, method transfer and method comparison reports along with all addendums and amendments
- All sample analysis reports, addendum and amendments
- All Lab Investigation reports
Stubbs & Hensel will provide:
- Preliminary report describing low, medium and high risk issues
- Consultation with sponsor and CRO to mitigate selected medium and high risk issues
- Follow-through with CRO to assure that appropriate risk mitigation and documentation has been accomplished
- Final report describing all findings and mitigations employed
Stubbs & Hensel will provide support to answer any FDA questions related to the bioanalytical portions of the submission

CRO or In-House Bioanalytical Laboratory Evaluation

Stubbs & Hensel will provide:
- 2-Day on-site Lab evaluation
- Full debrief with laboratory staff on Day 2 of findings
- Full Laboratory Evaluation Report within 1 week of completion of the site visit to include:
  - Evaluation of issues which impact regulatory risk
  - Recommendations to mitigate regulatory risk