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Strategize Regulatory Compliance

Strategize Regulatory Compliance Strategize Regulatory Compliance Strategize Regulatory Compliance

Navigate the R&D and Post-Approval Superhighway

Strategize Regulatory Compliance

Strategize Regulatory Compliance Strategize Regulatory Compliance Strategize Regulatory Compliance

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.  

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 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. 

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 ...

Leverage Our Industry Experience

WE.

PHARMA.

KNOW.

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. 

KNOW.

PHARMA.

KNOW.

Eisai 

Eli Lilly

Esperion Therapeutics 

Exl 

Jefferson Healthcare

GE Healthcare

GlaxoSmithKline

Greenphire 

Happy Medium

HITLAB

Icon

IQVIA

IronMountain

Jazz Pharmaceuticals

Johnson & Johnson

Jubilant DraxImage

Labcorp

Lockwood Group

LSTI 

Mallinckrodt Medical

MAPS Public Benefit Corp

Medpace

Merck

Mylan

NeoGenomics 

Novartis

PHARMA.

PHARMA.

PHARMA.

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 ...

Learn More About the Science of Quality Management

New Book Available Now (Productivity Press)

New Book Available Now (Productivity Press)

New Book Available Now (Productivity Press)

5-Star Career by Penelope Przekop

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

Learn More on Amazon

Available Now (McGraw-Hill)

New Book Available Now (Productivity Press)

New Book Available Now (Productivity Press)

Six Sigma for Business Excellence by Penelope Przekop

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. 

Learn More on Amazon

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