Consulting Services

Biotechnology - Medical Devices - pharmaceuticals

Regulatory affairs - quality systems - project management

 

Who we are

illumireg is different

 

illumireg was created to help biotechnology, medical device and pharmaceutical companies respond to an evolving regulatory landscape.  Our consultants are passionate about introducing and sustaining innovative products in challenging regulatory environments.  We pride ourselves on retaining the most distinguished consultants in the field.  No matter the situation, our team is prepared to confront any obstacles with the utmost professionalism.    

illumireg employs a tiered development system that ensures our consultants are always at the cutting edge.  We believe in fostering a corporate culture that encourages teamwork, continued education, and personal fulfillment.  Although we maintain strict standards, we understand the importance of having a workforce that is in good spirits so that they can perform to their full potential.  We use these methods to fuel our commitment to our clients and ensure they are receiving the most dedicated and prepared consultants in the business.

Our team has a diverse background that includes experience in launching innovative products and working with companies under warning letters and consent decrees.  We believe that diversity is an engine for innovation and credit our team's variety of experiences for their continued success.  

Please contact us if your are interested in job opportunities:   jobs@illumireg.com 

 

 

Our elite level consultants are required to:

1. Hold a graduate degree in their respective field.  This can be an MS, ME, MD, JD, PhD, PharmD or a graduate degree in a similar scientific discipline conducive with their area of expertise.  

2. Maintain at least 2 certifications in their respective field such as PE, PMP, RAC, CQA, CQE, CBA, CMC, etc.

3. Have at least 10 years of experience.

4. Actively participate in external groups in order to share their knowledge with the community.

5. Have a personality that can stand up to the challenges they will face and inspire those around them. 

What we do

Problem solving and optimization

 

At illumireg our only goal is to help our clients.  From multi-billion dollar blue chips, to 5 person start-ups, we treat each company with the same level of respect.  We focus on 3 main areas of consulting for Biotechnology, Medical Device and Pharmaceutical companies:

Regulatory Affairs

From due diligence to remediation -  Our team has the experience to find solutions in an evolving regulatory environment.  

Quality Systems 

From the ground up or optimization -  We can help you develop a compliant and efficient quality system.

Project Management

The experience to stand up to challenges in critical and reticent situations.  

Why choose us

The experience and credentials to back it up

At illumireg we maintain strict standards so that we can maintain your trust.  We live in the digital age where information is only a few clicks away.  This ability can be an advantage in the hands of an experienced professional but can also lead to catastrophe when used by the unqualified charlatan.  Many firms claim to be "experts" and provide "intelligence" but rely too heavily on external resources for their information.  When everything is on the line, our clients want someone who has been there.  We have been through the fires and know how to put them out and prevent them from recurring.  Before you choose a consulting firm we recommend you check their:

Credentials

From what we have seen, NO other firm that specializes in regulatory affairs and quality systems consulting maintains standards as strict as illumireg.

Experience 

Genuine references from all organizational tiers, including C-suite, Venture Capital and Private Equity, to back up our claims.  

Attitude

We look to create, and when necessary disrupt, but never destroy.  We believe in respecting each individual no matter the circumstances and when our projects are over, we ensure you maintain the momentum to continue to succeed.  

Contact

We really enjoy what we do

If you have any type of question about regulatory affairs, quality systems or project management feel free to contact us.  We love what we do and consider sharing our knowledge to be a responsibility. 

 

email

contact@illumireg.com

This is our preferred form of communication.

phone 

Main voice mail box: 312.775.2344

Your call will be returned within 24 hours.  

social media

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