At PharmTox Regulatory Writers (PTRW), we provide nonclinical regulatory consulting and writing expertise to the pharmaceutical and biotechnology industries. Our professional practice offers: drug development consultation with global market knowledge, 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: oncology, infectious diseases including HIV, respiratory, neuroscience, metabolic, cardiovascular, imaging agents, and immuno-inflammation. The knowledge and skills at PTRW come from direct leadership 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 includes work with both remote and diverse project teams. PTRW also has a considerable level 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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