Strategize Regulatory Compliance
Navigate the R&D and Post-Approval Superhighway
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Navigate the R&D and Post-Approval Superhighway
We develop and execute risk-based strategies that support comprehensive global regulatory compliance throughout the drug development process and product lifecycle.
We draw on our experience and insight to help pharma sector companies create and execute compliance strategies. With 30 plus 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 of Clinical Development, Pharmacovigilance and 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.
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
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 ...
We create risk-based solutions for your drug development
and post-approval quality and compliance challenges.
The best strategy is to proactively identify and execute compliant,
fit for purpose, solutions in anticipation of industry-standard challenges.
Abbot Laboratories
Acorda Therapeutics
Alexion Pharma
Allergan
Amersham Health
Amgen
Ashfield Healthcare
Astellas Pharma
AstraZeneca
Baxter
Bedrock Group
BeiGene
BioForum, Ltd.
Biogen
Boehringer Ingelheim
Cedars-Sinai Medical Center
Celgene
ClinTrak
Cogstate
Collegium
Columbia University
Corcept
Covance
Depomed
Daiichi Sankyo
DSG, Ltd.
Eisai
Eli Lilly
Esperion Therapeutics
Exl
Jefferson Healthcare
GE Healthcare
GlaxoSmithKline
Greenphire
Happy Medium
HITLAB
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IQVIA
IronMountain
Jazz Pharmaceuticals
Johnson & Johnson
Jubilant DraxImage
Labcorp
Lockwood Group
LSTI
Mallinckrodt Medical
MAPS Public Benefit Corp
Medpace
Merck
Mylan
NeoGenomics
Novartis
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Ono Pharma
Otsuka
Pfizer
ProPharma
Puma
Regeneron Pharma
Rho
Roche
SanBio
Seattle Children's Hospital
Sloan-Kettering
Takeda
Tata
Temple University Healthcare
The Doctors Laboratory
ThermoFisher Scientific
Theradex Oncology
Theravance
Triad Isotopes
Tyco Healthcare
Vigilare International
WCG Clinical
Valeant
Xendo
Wyeth
And more ...
Industries across the globe manufacture products and provide services that you deem 5-star worthy; their goal is to satisfy your needs and desires. They follow the proven science of quality management to make that happen because it makes common sense, and its effectiveness is irrefutable. 5-Star Career: Define and Build Yours Using the Science of Quality Management provides common sense, strategic context for personally implementing quality concepts that reflect your goals as well as your own definition of a 5-star life and career
Six Sigma for Business Excellence shows managers at all levels of Six Sigma proficiency how to create a process excellence program that addresses both company goals and day-to-day operations.
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.
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