Scientific and Medical Writing Services
High‑quality medical and scientific writing services to support clinical development, regulatory submissions, and scientific publications/communication across all stages of development. We support programs spanning small‑molecule drugs, biologics (including vaccines), medical devices, combination products, and companion diagnostics, and covering a broad range of regulatory pathways and development strategies, including new chemical entities (NCEs), repurposed products, 505(b)(2) submissions, biosimilars, and biobetters. Our teams deliver high‑quality, submission‑ready documents aligned with FDA, EMA, and ICH guidelines.
Value
Accelerate drug development
Minimize infrastructure investment
Rapid start with experienced team
Reduce program risk
Build asset value
Clinical Study Protocols and Informed Consent Forms (ICF) Writing
Well‑designed clinical study protocols and informed consent documents are critical to study execution and regulatory compliance. Uniphar supports the development of clinical study documentation that is scientifically rigorous, operationally feasible, and aligned with regulatory expectations.
Clinical protocol and ICF services include:
- Protocol synopses
- Clinical study protocols and amendments (Phases I–IV)
- Informed Consent Forms (ICFs)
- Supporting protocol‑related schedules and documentation
- Alignment with ICH E6 (GCP) and applicable regulatory requirements
Our writers ensure scientific rigor while maintaining clarity for investigators, regulators, and study participants.
Nonclinical and Clinical Regulatory Writing Services
Uniphar provides nonclinical and clinical regulatory writing services that clearly and accurately communicate study design, conduct, and outcomes in accordance with regulatory guidance. Our writers ensure consistency, traceability, and data integrity across source documentation, supporting efficient regulatory review.
Nonclinical writing support includes:
- Summaries of nonclinical studies for inclusion in meeting packages, annual reports, IBs, etc.
- CTD Module 2 nonclinical summaries to support IND and NDA/BLA/MAA filings
Clinical writing support includes:
- Full CSRs aligned with ICH E3
- Interim and final study reports
- Presentation of clinical study results and conclusions
- CTD Module 2 summaries to support IND and NDA/BLA/MAA filings
- Integrated summaries to support regulatory submissions, including NDA/BLA filings
Investigator Brochure (IB) Development and Writing
Investigator Brochures are critical tools for communicating clinical and nonclinical data to investigators and regulators. Uniphar develops IBs that present data clearly, accurately, and in alignment with global regulatory expectations.
Investigator Brochure services include:
- Initial Investigator Brochure development
- Integration of emerging preclinical and clinical data
- Safety and risk‑benefit summaries
- Updates and lifecycle maintenance
- Support for IND‑stage development programs
IBs are developed as living documents that evolve alongside the development program.
Scientific Publication and Manuscript Writing
Uniphar supports scientific publication activities to communicate study findings and development insights to the broader scientific and medical community.
Scientific publication services include:
- Manuscript writing and editing for peer‑reviewed journals
- Abstracts and posters for scientific conferences
- Data summaries and figures for external communication
- Journal submission support and responses to reviewer comments
Our focus is on clear, accurate scientific communication aligned with publication standards and Sponsor objectives.
Book a Medical and Scientific Writing Consultation
Get clear, submission-ready documentation support. Schedule a free 30-minute consultation with Uniphar to discuss your program stage, document needs, and timelines.
