Recently we sat down with Michelleanne Bradley, Founder and CEO of Metis Consulting
Services, a local boutique consultancy firm that emphasizes women and diversity. Michelleanne
is a member of the SDEE Consultants Group and joined SDEE in 2018.

What does Metis specialize in?
Metis Consulting Services is a boutique international consultancy serving Biotech and
Pharmaceutical Industries. Metis is focused on GxP services, with specialization in
Pharmacovigilance, Quality Assurance, Acquisition Integration (M&A), REMS, Scalable
Implementation Planning, and Compliance services. We are a woman founded and run
organization.

Why is it important to hire a company like Metis?
Quality Assurance is the structured framework that provides momentum and flow for all areas of
development to be able to focus on the specialized parts of development, it is both the
foundation and overarching support system. Pharmacovigilance is the practice of monitoring
the effects of medical drugs after they have been licensed for use, especially in order to identify
and evaluate previously unreported adverse reactions. Engaging in a mock regulatory audit, a
QA inspection, or an evaluation of your internal practices can all support consistent compliance
to regulations, as well as enhance current and future patient safety.

Who are Metis’ clients?
We specialize in Biotech and Pharmaceutical companies that may not have the infrastructure, or
experienced staff, to handle their own oversight, auditing, and compliance needs. We do gap
analysis to find the areas in a company’s practices that need additional assistance, and we
generate action plans which prioritize the elimination of those gaps. Many newly formed
businesses don’t have written standard operating procedures, so we also support them by
getting those in place.

What is Metis doing these days?
The REMS program in the United States is changing with the addition of the REMS Industry
Consortium and Metis is at the forefront of this collaborative effort with Pharmaceutical
companies.

Metis wants to change the audit landscape between CROs and their Sponsors. Advising
companies to schedule their audits earlier in the year to avoid last minute annual audits is a key
factor in this. Metis Certified is an initiative that will aid companies to have less audits and
lessen the burden of the audit workload.

Metis is hosting the Queens of Quality Podcast to advise companies within the biotech, device
and pharmaceutical space. All companies need to follow the same regulatory requirements.
This podcast is intended to provide insights on how these requirements can be implemented in
a compliant, scale-able and sustainable manner for organizations at any point within the
company life cycle.

Metis has been invited by BII World to present and train on the topic of Drug Safety and
Pharmacovigilance in March 2022. BII World hosts global events that include training,
conferences, and virtual events all year long.

Why did you start your consulting firm, Metis?
In my vast corporate experience I saw two things that kept recurring, and that was that women
were not seen and heard equally to men, despite their expertise and knowledge. The second
was the lack of life/work balance that companies say they encourage but find difficult to
implement. My goal is to build the type of company that is led by a C-Suite whose leadership
takes into consideration the personal lives, mental health, and well-being of its team. We try to
extend this philosophy to the companies we consult with as well. Our goal at Metis is to be
holistically employee focused. When you keep all of the facets of employees in the forefront,
quality work is a natural byproduct of that healthy environment.

Why did you name your company after the goddess Metis?
In Greek Mythology, the goddess Metis is the embodiment of wise counsel. I would like to think
that as a company we pass on wise counsel to our clients from our breadth of experience.

What do you like about being a SDEE Member?
SDEE helps business leaders meet and compare notes. They provide community and
resources that are valuable for small businesses like Metis