Clinical & Pharmacovigilance Quality Systems
Growth Phase Compliance
Quality Systems Gap Assessment
Quality Systems Documentation
Regulatory Advisement & Responses
Cedars-Sinai Medical Center
Johnson & Johnson
Seattle Children's Hospital
Temple University Healthcare
The Doctors Laboratory
And more ...
We draw on our experience and insight to help pharma sector companies create and execute compliance strategies. With more than 25 years of pharma quality and compliance experience, we're uniquely qualified to fill several expanding, dovetailing industry gaps related to Clinical and PV Quality Systems, including vendor oversight.
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.
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 ...
Give us a quick call any time. If possible, we'll chat on the spot or set up a time that works well. We look forward to hearing from you.
Prefer email? Reach out via email and we'll respond as soon as possible. We're happy to interact via email. We can always schedule a call if you'd like. As a rule, we don't make unsolicited calls to anyone. We know you're busy and so are we.
We focus on strategy, execution, and professional development within the Pharma/Biotech GCP and PV Quality Systems & Compliance space.
We develop tailored, intensive mentoring workshops unique to the industry focused on filling known industry-wide quality and compliance gaps.
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