Trilogy Writing & Consulting GmbH

Trilogy Writing & Consulting GmbH is a German-based medical writing consultancy specializing in regulatory documentation for the pharmaceutical and clinical research industries. With over 20 years of experience, the company provides medical writing services that focus on regulatory submissions, clinical study documentation, and scientific communications for pharmaceutical companies and clinical research organizations worldwide.

The firm positions itself as an outsourcing partner rather than a simple writing service, with writers integrating into client teams to plan, coordinate, and produce regulatory documentation. Their core competencies include ICH-compliant Clinical Study Reports, submission dossiers, study protocols, and pharmacovigilance documents. The company operates as part of Indegene, providing access to broader resources while maintaining specialized focus on regulatory medical writing.

Trilogy's approach emphasizes document readability and reviewer-friendliness to reduce review and approval times. The company serves pharmaceutical companies and CROs of all sizes, with particular expertise in pre- and post-marketing documentation requirements.

Organizations should consider Trilogy when regulatory submission quality and compliance are critical priorities. The company's two-decade track record in regulatory writing suggests deep institutional knowledge of evolving ICH guidelines and global regulatory requirements.

Expect a collaborative engagement model where Trilogy writers function as extensions of internal teams rather than arm's-length vendors. This approach works well for organizations seeking long-term partnerships to streamline documentation processes and reduce internal review cycles through higher-quality initial submissions.

Trilogy serves exclusively pharmaceutical and biotechnology healthcare sectors, with specialized expertise in clinical trial documentation and drug regulatory submissions. The company's healthcare focus centers on supporting the drug development lifecycle from clinical study protocols through post-marketing pharmacovigilance reporting.

Their regulatory expertise spans EU regulations (EMA submissions), FDA requirements, and ICH guidelines, with demonstrated knowledge of agency-specific documentation standards including Clinical Study Reports, Investigator's Brochures, and Common Technical Documents for marketing authorization applications.

Mid-sized to large pharmaceutical companies and CROs conducting multi-national clinical trials requiring regulatory submissions to FDA, EMA, and other global authorities. Organizations seeking to outsource regulatory writing while maintaining close collaboration and quality control over documentation processes.