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| Qtech Solutions
provides medical and technical writing as an integral part
of a full drug development program, a Phase I - IV clinical
trial, or as a stand-alone service. Qtech Solution's experienced
team of writers ensures that your regulatory submission documents
are clear, concise, scientifically and medically accurate,
and fully compliant with all applicable ICH (http://www.ich.org)
and regulatory requirements. |
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Fully integrated clinical and PK/PD reports
for electronic submission.
- Marketing/regulatory documents —
writing and editing.
- Protocol preparation
- SOP writing.
- Investigational New Drug Applications
(INDs).
- Clinical Trial Applications (CTAs).
- Clinical Trial Exemptions (CTXs)
- New Drug Application (NDA or CTD format;
paper or electronic).
- Marketing Authorization Applications
(MAAs).
- Pre-market Approval Applications (PMAs)
.
- Final report writing.
- Presentations at FDA meetings.
- Investigator's Brochures.
- Clinical Sections of Annual Reports
- Clinical Study Report.
- Safety/Efficacy Summaries.
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