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Regulatory
Affairs
Guided
by our own in-depth knowledge of the integrated drug development process,
B&H can partner or lead your regulatory efforts across a product's
life-cycle at both the strategic and operational levels.
- Provide
expert advice on regulatory strategy
- Prepare and implement regulatory Standard Operating Procedures
-
Prepare,
review and assemble investigational applications, including
verifying and evaluating documentation.
- Work at
client sites to handle their day-to-day regulatory operations. Tasks include but are not limited to:
- Prepare
information and protocol amendments, individual case safety reports and all
necessary
correspondence to FDA
- Audit investigator documentation to ensure compliance with 21
CFR 50 and 21 CFR 56
- Approve and process shipping orders for investigational use
- Prepare
export documentation for non tier-one countries; assure all appropriate
export documentation is in place for tier-one countries
- Manage
labeling changes for USPI, SmPC and Core Data sheet
- Review study protocols, study reports, and completed
CRFs,
for submission accuracy/
completeness
- Prepare background documents
in advance of sponsor meetings with Health Authorities
- Prepare, review and assemble
marketing submissions to global regulatory authorities for the following
product categories:
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Drugs,
orphan drug and fast track applications -
Generic
drugs -
Devices,
including diagnostics -
Biologics -
Veterinary
products
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Liaise
with health agencies to resolve issues and expedite marketing
approvals
- Prepare/submit
Drug Establishment Registration/Renewals and Drug Product Listings
- Manage/input study information in FDA database of investigational protocols for
treating serious and life threatening diseases
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