Aroga Biosciences, Inc.

Aroga Biosciences is a boutique, full-service CRO specializing in regulatory and medical writing services for biotech and pharmaceutical development. Founded by scientists, the company brings together deep regulatory knowledge, rigorous quality standards, and collaborative expertise to support life sciences companies from first-in-human studies through global regulatory submissions.

Core Services

• Medical Writing: High-quality, compliant, scientifically accurate documents from early development through regulatory submission, including INDs, IBs, protocols, CSRs, and Module 2/Module 5 summaries.
• Clinical & Regulatory Documentation: Expertise across clinical, nonclinical, and regulatory strategy with experience in all major document types.
• Quality Control: Rigorous, data-driven QC verifying accuracy, formatting, style-guide adherence, and scientific and data integrity.
• Regulatory Operations: Complete document publishing and submission management, formatted and validated for electronic submission (eCTD).
• Project Management: Strategic planning, cross-functional coordination, and end-to-end ownership from initiation to submission.
• Document Delivery & Copyright Management: Compliant, lawful use of published scientific literature with enterprise licensing and audit-ready oversight.

Therapeutic Area Expertise

The team has in-depth experience across oncology, rare diseases, neurology, infectious disease, and additional therapeutic areas. All writers and QC professionals hold advanced degrees (PhDs, PharmDs) and maintain current knowledge through attendance at AMWA and DIA conferences.

Operational Model

Fully remote and globally distributed with staff across Pacific, Central, and Eastern time zones, enabling seamless collaboration with clients across regions.