Our Pharmaceutical Services

Celegence provides the pharmaceutical industry with consulting services that are tailored to the evolving operational and strategic needs of manufacturers in areas such as RIMS data management, publishing, and medical writing.

Our suite of pharmaceutical services allow you to focus on core activities while we work as an extended part of your regulatory team to ensure compliance and efficiency.

Regulatory Publishing & Submissions

Tackling global submission challenges.

IDMP & Compliance Consulting

Organizational readiness assessment for IDMP, xEVMPD and UDI compliance and support activities like data collection, maintenance, submission and governance.

Medical Writing

Specialty knowledge across various product types for multiple regulatory documents and application types.

Regulatory Affairs Consultancy and Support

Celegence provides tailored strategic and procedural support to enable pharmaceutical companies to successfully realize their goals and become launch-ready.

Regulatory Labeling

Supporting client requirements from creation to maintenance of global and local drug product labeling.

Regulatory Operations & RIMS Management

Registration tracking, planning and reporting on clinical trial authorization applications and marketing authorization applications is a complex task.

CMC Consultancy & Management

Chemistry, Manufacturing, and Controls activities span the entire drug development lifecycle, from preclinical research to post-market surveillance.

Additional Information

Download the latest brochure of our capabilities and services.

Pharmaceutical Industry Regulatory Affairs - Celegence