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PHARMACEUTICAL INDUSTRY :
Regulatory Affairs
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| | Client: |
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A world leader
in the pharmaceutical industry with a global footprint, recognized
as a standard-setter within the industry.
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| | Problem: | |
The company's busy Regulatory Affairs Department was severely affected by employee transitions, creating a backlog of work at a critical time. FDA requests required immediate response. The company determined there was no time to waste; outside help was needed to fill the gap until new employees could be hired.
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| | Approach: | |
Tunnell conducted
an immediate assessment to learn the scope of work demanded. It was
determined that a team of Tunnell professionals would be required
for a year-long effort to control the backlog in the Regulatory Affairs
CMC Group, Regulatory Affairs Labeling Group, and Regulatory Affairs
Pharm/Tox/Clinical Group so deadlines could be met. The team's efforts
included:
Regulatory Submissions: Wrote regulatory supplements,
the CMC section of annual reports, int'l RA dossiers for product
re-registrations, and the information package for an FDA pre-IND
meeting. Reviewed and provided comments for all regulatory supplements
and annual reports.
Regulatory Guidance: Explained regulatory requirements
for reporting manufacturing changes, labeling changes, etc.. Led
regulatory strategy for preparation of new IND. Wrote and directed
preparation of IND for submission to FDA. Assisted in planning first
clinical study.
Regulatory Review of Documents: Reviewed all change controls,
packaging specifications, manufacturing batch records, validation
batch records, and bill of materials for CMC Regulatory Affairs.
SOPs: Reviewed SOPs for the change control system from
three manufacturing sites and SOPs for the review of packaging specifications
and batch records. Provided recommendations to RA and QA for streamlining
the process and improving compliance with regulatory requirements.
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| | Results:
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Completed all
required regulatory submissions on time; all were approved.
Designed and implemented a new customized database for the tracking
of regulatory submissions, change controls and Rx labeling components
Wrote and implemented new SOPs for streamlining processes, including
domestic/ int'l review of change controls, preparation of annual
reports, preparation of int'l RA dossiers, and review of Rx labeling
Boosted efficiency in the regulatory review of documents, eliminating
redundancy
Transitioned work projects to new RA staff, training employees
on new processes and procedures to ensure a smooth transition
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