Strategize. Navigate. Arrive.

Pharma Compliance Strategy Development & Execution

We develop and execute risk-based strategies that support comprehensive global regulatory compliance throughout the drug development process and product lifecycle. The "big vendor" is emerging, driving global regulators to enhance their focus on Clinical and Pharmacovigilance (PV) Quality Systems, PV Compliance, and Vendor Oversight. Pharma and Biotech companies of all sizes and maturity levels are grappling with how to effectively and agilely launch or pivot using risk-based approaches. 

It starts with a solid compliance strategy.  

Professional Development

We work with a few of the top industry training companies and also offer our own unique professional development workshops to industry professionals. We facilitate tailored inhouse workshops as well. All of our workshops are designed to support the development and implementation of solid, risk-based pharma and biotech compliance strategies. 

Our Services

 Our areas of expertise are listed below along with some of the most common industry questions and challenges related to each. Our flexible approach has proven successful for developing and executing pharma and biotech compliance strategies. Every company is unique; we don't subscribe to cookie cutter solutions nor should you.  We're a boutique strategy company. We enjoy building client relationships that enable us to truly understand your vision, business backstory, and goals. We're passionate about compliance, creativity, and common sense.  

Strategy Development

Clinical & Pharmacovigilance (PV) Quality Systems Strategy


Questions & Challenges: 

You're telling me that we need a quality system despite our vendor strategy? Why do we need a quality system if they have one? And we have a Big Vendor; they know what to do. That's why we're using them. 

 We have many processes and systems in place. We know there are issues but don't know where to start or how best to prioritize and/or address them. We also don't know what we don't know. What is the best strategy for rebuilding our foundation to ensure efficiency and compliance while positioning ourselves for growth?    

Clinical & Post-Marketing PV Compliance Strategy


Questions & Challenges: 

How can we find and select the right PV vendor? If we need to rely on vendors for clinical safety or post-marketing PV because we lack the infrastructure and experience, how do we choose the right one and ensure that their services meet industry standards and regulatory expectations?  

Once we find a PV (or other) vendor, how can we demonstrate our compliance as a Sponsor/Market Authorization Holder, including vendor? We hired them to help us! We know our compound/product inside and out, but they know more about the services we've delegated to them. 

Growth Phase Compliance Strategy


Questions & Challenges:  

The market is ready for the BIG vendor and we're part of creating it, have been acquired, or are merging with another vendor. How do we efficiently dovetail our various quality system elements to provide services that are both efficient and compliant? What's the best strategy for merging our quality systems components, identifying the overlaps and any existing gaps, all while remaining compliant during the process?

What do we need to do to seamlessly move from a clinical focus to post-marketing pharmacovigilance? 

PV Auditing & Inspection Readiness Strategy


Questions & Challenges: 

PV auditors are like gold! There's an growing industry shortage of PV auditors and quality consultants. Where can I find these professionals? How can we effectively oversee PV QA consultants and ensure that they're providing quality deliverables?  

We're not as inspection ready as we should be or we're not confident about our level of inspection readiness. What's the best strategy for getting inspection ready and what should we do in the meantime? What if a regulator shows up before we're ready?

Professional Development Strategy


Questions & Challenges: 

There's an obvious industry shortage of PV auditors and quality consultants. We have great auditors but they don't have PV experience. Where can we find in depth training for our auditors that will enable them to quickly get out there and conduct PV audits?  

I'm a GCP QA Consultant but would like to move into the PV space. I can't get PV consulting projects because I don't have PV experience. What's the best strategy for me? 

Go here for more information. 

Corporate QA Organizational Strategy


Questions & Challenges:

We don't know what we don't know. How do we establish a great QA team if we don't have the expertise to evaluate the candidates?  Is expertise in one GXP QA area transferrable to another?  Our QA leadership comes from manufacturing. Are they able to build and execute a Clinical and/or PV QA organization or recognize the best candidates?  What's the best strategy? Can you assist us with job descriptions and interviews? 

Strategy Execution


GCP & PV Quality Systems Gap Assessment & Analysis

You may not know what you don't know.  Ensure that the right professional assesses your level of compliance.  This is our area of expertise. Our expert advice and deliverables come sugar-coating free and filled with solutions.  

Audits & Mock Regulatory Inspections

Can't find a PV auditor or mock inspector? This is our area of expertise. We can assist you in performing PV audits and mock inspections, or in locating an auditor or mock inspector.  

Vendor Oversight

In the growing "Big Vendor" pharma culture, regulators have higher expectations for Sponsors and Market Authorization Holders to execute and demonstrate vendor oversight. Many companies aren't quite sure what should be done and how considering that vendors are contracted to fill gaps in company expertise. We can help with strategy and execution of Clinical and PV vendor oversight.  

Quality Systems Documentation

Two common industry scenarios are: 1) the company has a quality system on paper that either doesn't reflect reality or is simply not up to regulatory and industry standards and 2) the company has many of the quality system elements in place but they're not properly documented. Clinical and PV Quality Systems are our focus. We can assist in establishing a solid, practical, documented Quality System. 

Professional Development Programs

We offer intensive development workshops that are unique in the industry. We use small group mentoring approaches to provide experience rather than training, and confidence in addition to knowledge.  Various workshops are under development.  We also provide tailored in-house workshops.

Regulatory Advisement & Responses

Need general or specific GCP or PV regulatory advice or assistance with a regulatory inspection response? We pride ourselves in not only our industry experience and knowledge but our communication and writing skills. Don't underestimate the power of the written word in communicating your regulatory response. 

Reach Out

Call Us at 267.980.4566

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. 

Email us at

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. 

Learn About Our Services

We focus on strategy, execution, and professional development within the Pharma/Biotech GCP and PV Quality Systems & Compliance space.  

Learn About Our Unique Workshops

We develop tailored, intensive mentoring workshops unique to the industry focused on filling known industry-wide quality and compliance gaps.