Strategize Regulatory Compliance
Navigate the R&D and Post-Approval Regulatory Superhighway
Strategize Regulatory Compliance
Navigate the R&D and Post-Approval Regulatory Superhighway
What We Do
How We Operate
What We Do
We draw on our experience and insight to help pharma sector companies create and execute compliance strategies. With 25 plua years of pharma quality and compliance experience, we're uniquely qualified to fill several industry gaps related to GxP Quality Systems, particularly in the areas Clinical Development, Pharmacovigilance and vendor oversight.
Why Us
How We Operate
What We Do
We know the pharma industry inside and out, the drug development process start to finish, and the global regulatory requirements that impact your business. We understand the required strategic elements, how they should be prioritized and dovetailed, and how to execute for success. We're passionate about logic, creativity, and compliance.
We know the pharma industry inside and out, the drug development process start to finish, and the global regulatory requirements that impact your business. We understand the required strategic elements, how they should be prioritized and dovetailed, and how to execute for success. We're passionate about logic, creativity, and compliance. The industry needs more of all three and we're here to champion the cause.
How We Operate
How We Operate
How We Operate
What keeps you up at night? We pride ourselves in making the truth palatable, gaps actionable, and solutions practical. We partner with our clients to build relationships and positive outcomes while telling it like it is. Our expert advice and deliverables come sugar-coating free and filled with solutions. Don't know where to start or how
What keeps you up at night? We pride ourselves in making the truth palatable, gaps actionable, and solutions practical. We partner with our clients to build relationships and positive outcomes while telling it like it is. Our expert advice and deliverables come sugar-coating free and filled with solutions. Don't know where to start or how to sort out what's already in motion? In either scenario, we can connect the dots and create a common sense strategy that supports life cycle compliance. Yes, so you can sleep at night ...
Our Approach
Let's Zoom
Reach out if you would like to meet with our CEO, Penelope Przekop, to explore possibilities. Every company is unique; we don't believe in cookie-cutter solutions nor should you. We enjoy building client relationships that enable us to truly understand your vision, business backstory, and goals.