Welcome to Themis

Your trusted partner in navigating the complex landscape of biopharma quality and regulatory compliance. With a deep commitment to excellence and a wealth of expertise, we specialize in providing comprehensive consulting services across the full range of clinical development.

About US

At Themis, our dedicated team of seasoned professionals brings a wealth of knowledge and experience in quality assurance, regulatory affairs, CMC operations, and GMP compliance. We understand the intricate and evolving requirements of sponsors and offer tailored solutions to meet your specific needs.

We pride ourselves on delivering strategic guidance that balances practical solutions and compliance expectations based on each individual company’s resources and phase of development. From startups to established corporations, our goal is to enable you to achieve and maintain compliance so high-quality products are brought to the market efficiently. We assist clients with Quality oversight, Regulatory strategy & support, and provide strategic guidance and tactical support for CMC operations.

Our mission is to empower our clients by offering personalized, expert guidance that not only meets regulatory standards but is also commensurate with the current phase of development. We help you implement scalable systems that can grow with your platform. By partnering with Themis, you gain a team of trusted advisors committed to your success in navigating the dynamic and demanding biopharmaceutical landscape.

Our Services

Quality Assurance

Themis offers a full range of Quality services, customized for each client’s needs:

  • Vendor audits & oversight

  • Batch record review

  • Quality Systems implementation

  • SOP writing & reviews

  • Personnel training

  • Deviation & CAPA Support

  • Investigations

  • Contract quality services, including batch release

  • Internal audits

Regulatory Affairs

With decades of collective experience working directly with FDA, Themis is a valuable partner to help with:

  • Regulatory strategy

  • FDA meetings & responses

  • Drafting & reviewing clinical documents (protocols, Investigator Brochures)

  • Drafting IND, NDA, & DMF documents

  • Submission of Annual & CARES Act reports

  • Publishing into eCTD format

  • Submission through FDA’s ESG

  • MoCRA support

CMC Support

Themis is here to help you navigate the complexities of biopharma development by offering CMC support, including:

  • Strategic planning & forecasting

  • Manufacturing process review and optimization

  • Technical review of batch records and investigations

  • GAP analyses for PAI-readiness

  • Due diligence audits for potential investors

  • Technical support for downstream and upstream operations for both

Contact Us

If you have any questions regarding Themis or would like to request our services, please fill out the form to the right.