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| Qtech solutions
regulatory affairs professionals are dedicated in ensuring
the successful and timely submission of your application.
Our regulatory affairs staffs have extensive experience in
the development of submission strategies that expedite agency
review from project initiation to completion, to determine
your specific business needs and to meet your timelines innovative
approaches to support effective and timely resolution of regulatory
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Essential
services include: |
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Expedite the compilation and submission
of y our application with Sponsor representation with
FDA (http://www.fda.gov)
or to the Regulatory departments.
- Pre-IND submissions and meetings.
- Investigational (IND and IDE) applications
in the United States and internationally.
- Regulatory filing packages for clinical
studies
- Submission and review of Institutional
Review Board approvals for clinical studies
- Regulatory Maintenance: Annual Reports,
SAE reports
- Regulatory expertise covers wide range
of therapeutic areas and types of submissions
- Proactive liaison and interface with
key FDA review and compliance divisions and international
regulatory authorities
- Planning strategies for most effective
and timely review and approval of regulatory submissions
- Investigational products, marketing approvals,
drug master files, orphan drugs and priority review submissions
- Electronic submissions.
- Post-marketing surveillance/pharmacovigilance.
- Development of Standard Operating Procedures
- Development and maintenance of Regulatory
Tracking database.
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