Efficiency, Innovation and Savings —Clinical Development to Marketing & Product Launch
Clinical & Regulatory
Project Management. Delivered.
Business-critical, whether urgent or routine.
At your fingertips.
Always our number one priority.
- INTEGRITY: Our dedication to impeccable ethics is fundamental to doing business.
- DEPENDABILITY: We are committed to delivering with excellence for all of our stakeholders.
- BROAD-BASED AND DIVERSE: Our wide-ranging skills and broad, global experience is a significant strength.
- DELIVERING WITH EXCELLENCE: High quality standards, a strategic focus and attention to detail enables us to meet or exceed clients’ objectives.
- To partner with companies to provide solution-focused, hands-on project management consulting and subject matter expertise to solve multifaceted business challenges, accelerate performance and reduce cost.
- We are steadfast in our goal to become the premier SME project management company.
Development & Commercialization
Here's what we have been up to:
Read about it… Current Certifications: WBENC-Certified Women’s Business Enterprise (WBE) NMSDC-Certified Minority Business Enterprise (MBE) SBA-Certified Woman-Owned Small Business (WOSB) WEConnect International-Certified Women’s Business Enterprise (WBE)
A clinical trial project manager (CTPM) is the nucleus of a clinical trial, therefore the success of each trial is heavily dependent on the performance of the CTPM. This recent article, 7 Breakthrough Behaviors For Clinical Research Project Managers, presents easy-to-implement strategies and tactics that will help CTPMs – and their organizations – achieve consistent[…]
FDA and Medscape series for healthcare professionals The interview features Gerald Dal Pan, MD, MHS, Director, Office of Surveillance and Epidemiology, FDA Center for Drug Evaluation and Research FDA. Dr. Pan responds to questions from Medscape to detail the FDA’s outlook on postmarket drug safety. The article is part of a collaboration between FDA and[…]
The FDA has about 200 orphan drug designation requests that are pending review and that number has been steadily rising over the past five years. Recently, the FDA publicized its strategic plan to clear the bottleneck as part of its strategic plan to eliminate the agency’s existing orphan designation request backlog and ensure continued timely[…]
In its effort to increase competition in the prescription drugs market and facilitate the entry of lower-cost alternatives, today the FDA published a list of branded drugs (based on the Orange Book Data Files) that have no listed patents or exclusivities and for which the agency has yet to approve a generic drug application. The[…]