Strategy and Development

Strategy and Pharmaceutical Development

PDG provides pharmaceutical strategy and development consulting expertise and serves as our clients’ regulatory voice at FDA. Whether you require a 505(b)(1) or 505(b)(2) NDA, PDG employs pharmaceutical industry professionals who routinely and successfully present client-proposed regulatory strategies to the Agency.
PDG strategy and development meetings with FDA routinely result in adoption of our clients’ initiatives. After submission of your meeting request, PDG will strategically compile a briefing package that reflects your scientific beliefs and objectives. Included will be favorable FDA precedent information and reasonable requests, with Agency responses anticipated in advance. We always leave options open for follow up meetings. On multiple occasions, PDG has revisited other consultants’ FDA results and come away with more viable development pathways. Our staff of professionals will work with you continuously to maximize the safety, efficacy and commercial value of your drug product. PDG’s focus is the growth of your business through line extension, strategic planning, additional indications, and more. PDG streamlines the pre-approval process to help you launch your product successfully – on schedule and on budget.

print