Themistry, Inc. Welcomes You

Providing Successful Regulatory and CMC Consulting Services

Themistry, Inc. offers a wide range of consulting services within the biotechnology and pharma space, specializing in Regulatory Affairs and CMC/Supply Chain. We partner with our clients from start to finish, focusing on their needs while producing new ideas, developing effective strategies and designing high quality and scale-able solutions. Contact us to learn more.

About Us

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Themistry, Inc. Consulting Services

Discover Our Expertise

Themistry, Inc. exists to solve the critical issues facing our clients, both large and small. Our unique approach is not only what differentiates us, but also what makes us successful. We provide a creative solutions to help organizations successfully navigate the regulated environment they operate in.

Cross-Functional Problem Analysis

Achieve Your Goals

We examine the challenges the organization faces by meeting with key stakeholders to understand the broader picture. We combine these insights with an in-depth understanding of biotech and pharma space. Any organization can move forward with small incremental changes within each silo; but building for the future in today’s rapidly evolving environment means developing strategies that:

make the right connections between seemingly disparate internal drivers
meet external stakeholder requirements
are realistic, achievable, and adaptable

Strategic Planning and Execution

Expert Guidance

Let us help you develop a plan for success and execute on your vision. Whether starting from the beginning or reviewing an existing strategy, we will provide relevant insights using 20+ years of global experience.
After developing your strategic plan with you, we can provide excellent technical writing, editing, and dossier development. Finally, we will prepare and coach your team so that they can present professionally to various Health Authorities and make tactical decisions in real time.
By identifying potential hurdles and developing contingency planning, we will help you develop a robust plan that can avoid delays to your development goals.

Building Your Processes and Teams

Meet Regulatory Requirements

Need help developing processes or training your staff but not sure where to start? Need solutions that work in your regulated environment and that meet cross-functional needs for long-term success? Want to improve efficiencies and at the same time provide transparency to stakeholders? Let us guide you.
We will evaluate your needs and provide tools and training. We will evaluate external stakeholder feedback to define learning opportunities.
We focus on organizational strengths as a way to stimulate personal and group excellence. Let us help you turn something strong into something superb!

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About Us

Shelley D. Suggett, MBA

I have extensive experience in global drug development and drug approvals. From standard submissions to complicated challenges, I have the experience to help you successfully navigate the regulatory environment and meet your goals.

While working on a breakthrough drug (Runner-up, Science’s “Top Ten Breakthroughs of the Year” Award 2006 ) for Age‑related Macular Degeneration (AMD), I had the privilege to meet a clinical trial patient who had been in the active arm of the clinical trial. The woman described how, after many years of vision loss, she was now able to see the faces of her grandchildren for the very first time.

That powerful moment always reminds me of the importance of our work and sets the tone for the passion I bring to my roles.

I have had roles in research, global regulatory affairs and supply chain management working with small, medium and large organizations in the pharmaceutical/biotechnology industry. I am well-respected by internal and external colleagues for my transparency and proven ability to troubleshoot and negotiate solutions to complex problems.

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Testimonials

Shelley was a regulatory consultant for us at my prior company. Prior to an FDA meeting, Shelley came in [and] helped to make our regulatory submission more concise and clear, and worked with us to prepare for the meeting. She was great to work with and really helped us maintain focus on the key elements necessary for a successful outcome...

— Paul Kwon MD

[Shelley] is one of the best CMC regulatory experts in Biotechnology. She is extremely scientific in her evaluations,presents them with confidence and encourages discussion and debate. Those that have worked with her have always been impressed and pleased with the quality of her work. Shelly is also extremely personable and professional in her approach to complex Regulatory issues. Working with her was a real pleasure.

— Robert Garnick

Shelley was an outstanding [product] team lead for the...products that she managed...she had a good understanding of the business, financial, quality, and technical areas. While Shelley dealt with the details, she was able to lead and manage the team from a bigger picture perspective during times when critical supply chain issues occurred. The team was able to meet all goals on time...she was also very supportive of her team members.

— Lori-Anne Boville

I had the pleasure to work with Shelley while she was serving as the Supply Chain Leader for our #1 brand. She is energetic and focused, and has always displayed great integrity and leadership skills while keeping things fun. I would welcome an opportunity to work with her again!

— Catherine Fischer

Shelley is a knowledgeable regulatory subject matter expert...She is an excellent team player and works collaboratively to understand people's needs and find appropriate solutions. she is easy to work with and can bring the best in people.

— Mike Zojaji

Shelley is a process driven team leader, who is able to balance individual member contributions to move the team forward.

— Sarah Schilbach

…Shelley was a pleasure to work with as I appreciated the way she balanced problem-solving through a creative thought process with her strong scientific background, as she managed projects thoughtfully to successful outcomes. Her leadership qualities are unique - as her disposition of both jovial and professional engages to many types of situations. She can adapt to various scenarios by listening and managing others' opinions and develops trust in others.

— Karen Offril

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