Meeting Requirements for Regulatory Submissions

Regulatory product approval in international markets requires stringent management of regional timelines and related translation activities
Oct 04, 2016

The International Council for Harmonization (ICH) has fostered increasing standardization of filing requirements for marketing authorizations of new or modified pharmaceuticals. Despite the development of the Common Technical Document (CTD) format, submission requirements remain quite diverse from one regional jurisdiction to another, presenting special challenges for companies seeking approval of their pharmaceutical products.

LUZ has created a solution brief to discuss in greater detail the requirements for managing critical milestones and translations of regulatory documents in preparation for on-time submission. See a sample application timeline as defined by the European Medicine Agency’s (EMA’s) Centralized Procedure and learn how to operate within short time windows.

Download our free solution brief to

  • Understand the challenges of regulatory timelines
  • Ensure documents are accurately translated
  • Identify the best collaborative process for meeting requirements

About LUZ, Inc.

Founded in 1994, LUZ is the world’s leading language translation company for life sciences. With a special focus on medical device, pharmaceutical, biotechnology, and clinical research organizations, we simplify and expedite entry into global markets by delivering accurate and compliant translations of product and regulatory documentation. LUZ is a certified women- and minority-owned business and maintains quality certifications to ISO 9001, ISO 13485, and ISO 17100 standards.

Press Contact

Waldemar Frank
VP, Product Management & Marketing
415.981.5890 ext. 138
waldemar.frank@luz.com