Compliance Remediation

If any inspection results in a compliance action from the FDA, or requires

corrective action, our experience in compliance remediation can help you get a
quick resolution to your deficiencies and back in a positive position with the FDA.
We understand the FDAs expectations, what is required under the regulations and
how to successfully manage different remediation activities. Our remediation
services have consistently resulted in success for our customers.
483/Warning Letter Response
Our typical approach is to review FDA documentation with your team and come up
with a plan and respond within five days. We will work to help you develop realistic
timelines and corrective actions to ensure that each item is resolved as soon as it is
feasible, meanwhile providing the FDA with your assurance that you do take this matter
seriously and are intent on compliance.
If any of these items require additional resources beyond your capability, we can either
provide resources from our company or other specialists who will ensure your deadlines
are met and that systems are in place to ensure future success. We can also participate in
meetings with the FDA or internal meetings to support compliance efforts.
Consent Decree
Consent Decrees are legal agreements between the FDA and a company that has either
continually received violations or has significant violations that pose a serious risk to
the public. These documents come in the form of plaintiff vs. defendant and typically
result in having to cease manufacturing and distribution of affected products until proof
can be demonstrated to the FDA that appropriate actions have been taken to comply
with applicable regulations. Failure to resolve a Consent Decree is costly in terms of
financial impact, lost revenue and public opinion of your business. Many companies
cannot recover from this type of action, however, with proper assistance, such actions
are completely avoidable.
Reglera has been through the process of clearing a Consent Decree with a client and
understands what it takes to be successful. If you find yourself in this unfortunate
situation, we have the understanding of requirements and the experienced team to
ensure your success.
Remediation Activities
No matter what your remediation needs are, we have the staff to manage the process and
to complete the required activities keeping you in compliance with applicable
regulations. We have assisted numerous companies, both large and small, with their
FDA commitments. Reglera allows you to acquire regulatory expertise efficiently
without bringing on additional full-time staff.

Compliance Remediation Services

When there is a change in compliance policy, or concern that diligence or processes

may not have been performed to the highest standard in the past, clients may require a
remediation (or look-back) of historical accounts and client relationships to ensure
they conform to current AML and other compliance policies.
In these cases, clients need to engage experts quickly, to both remediate the sometimes
years of history, and create auditable records to address regulators concerns.
Kroll knows that this is a huge challenge, and one that requires expertise and speed
to resolve. Kroll can field a scalable team of experienced resources anywhere in
the world, with the automated tools and processes that allow for remediation of a
population of accounts in a cost-effective and rapid manner. Because of our
compliance and AML research experience, were faster and cheaper than any other
firm.