Submission drafting
Prepare first drafts of NDA and BLA sections and responses to agency questions using prior submissions and source documents. Review and revise the draft in Word.
Learn moreSolutions / Pharma
Arca for Pharma
Research regulatory questions, compare clinical evidence, and draft submission and quality documents from published sources and your own files.
Pharmaceutical teams
From evidence to a draft your team can review.
Clinical evidence review
Extract study design, dosing, endpoints, and reported adverse events across published trials for a drug or its comparators, with each cell linked to the source paper.
Learn moreRepeatable quality work
Turn your team's SOPs and work instructions into repeatable research and drafting procedures that reviewers can check before sign-off.
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.