At PharmTox Regulatory Writers (PTRW), we provide regulatory writing expertise to the pharmaceutical and biotechnology industries for most global markets. The services that PTRW offers include: project management, reviewing data, and composing high quality regulatory documents for major submissions (m2.4, m2.6 & m4, as well as select other modules). We have experience across a broad range of therapeutic areas, including oncology, HIV (and other infectious diseases), respiratory, neuroscience, metabolic, cardiovascular, imaging agents, and immuno-inflammation. The knowledge and skills at PTRW derive from direct involvement in preparing files for BLA, NDA, MAA, NDS, and JNDA submissions and global eCTD files for other international markets. We also support earlier stage submissions for first-in-human clinical trials and Phase 2 and Phase 3 submissions. Our background encompasses work with remote and diverse project teams. PTRW also has a wide spectrum of business experience pertaining to joint venture partnerships, in-licensing opportunities, and other collaborations between companies. We have a successful track record in clinical trial application and marketing application approvals.
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