Trusted Clinical and Regulatory Writing for Pharma and Biotech
Acadustri combines scientific precision with regulatory insight to deliver high-quality clinical and regulatory documents for biotechnology and pharmaceutical companies at every stage of development. Our team has supported numerous successful submissions and scientific communications, helping clients navigate complex regulatory landscapes with clarity and confidence.
We ensure your documents meet global standards, present data effectively, and reflect the strength of your science.
We support the preparation of:
Clinical trial documentation
- Clinical Study Reports (CSRs) for Phase I–IV trials
- Investigator’s Brochures (IBs)
- Study Protocols and Protocol Amendments
- Informed Consent Forms
- Plain Language Summaries
Regulatory submissions
- IND and NDA documentation
- Investigational Medicinal Product Dossiers (IMPDs)
- Applications for Orphan Drug Designation (ODD)
- Briefing Books for EMA and FDA Scientific Advice
- Responses to EMA Day 120 & Day 180 Questions
- Responses to Regulatory Questions
Supporting materials
- Literature searches and reviews
- Slide decks, training materials, and other supporting documents
Whether you’re preparing for a regulatory milestone or communicating key clinical findings, we ensure your documents are clear, compliant, and strategically aligned.
What our clients say
Let’s collaborate
Please contact us for a confidential discussion about your project needs.
Call us on 07790 322 776