CMC drafting and review
Use your source documents and templates to prepare draft CMC sections and responses to agency questions, then review the evidence and wording in Word.
Learn moreSolutions / CDMOs
Arca for CDMOs
Research manufacturing requirements and prepare CMC and quality drafts from your technical records, SOPs, and reference documents.
Contract development and manufacturing organizations
From evidence to a draft your team can review.
Quality documentation
Draft and review SOPs and quality documents against your team's procedures, with suggestions linked to the supporting materials.
Learn moreManufacturing guidance research
Research FDA, EMA, and ICH expectations alongside your internal references to prepare cited summaries for the quality and regulatory teams.
Learn moreArca supports research and drafting. Your team reviews the evidence and remains responsible for the final document and regulatory decisions.
Connected to your workYour documents. Published evidence.