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:
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.[…]
FDA Issues Q&A Draft Guidance: Use of Electronic Records and Electronic Signatures in Clinical Investigations
On June 20, 2017, FDA issued the document Use of Electronic Records and Electronic Signatures in Clinical Investigations Under 21 CFR Part 11 – Questions and Answers Guidance for Industry DRAFT GUIDANCE. The goals of this guidance are as follows: • Update recommendations for applying and implementing part 11 requirements in the current environment of[…]