Our Services

What we offer

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

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

It’s impossible to list everything we have done or can do for clients – Contact Us to set up a complimentary discovery call with a Themis consultant. We’d love to discuss how we can serve you.

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