Post-Authorization Pharmaceutical Translation Services for Global Regulatory Compliance
Once your drug or therapy is approved and launched, our specialist translation services will support you through pharmacovigilance, regulatory submissions, and global compliance.
Clinical trials can only take a drug so far. Even the most diverse trial can’t test for everything, like the effects of extended use or the possibility of rare adverse events. At Conversis, an IQVIA business, we translate critical safety and regulatory documentation, helping you meet regional requirements and communicate clearly with regulators and healthcare professionals.
We combine decades of life sciences expertise, AI-enabled workflows, and a global network of subject-matter expert linguists to help you process large volumes of post-market data quickly and accurately. Our expertise ensures your post-market documentation remains compliant and ready for submission in every market and to global regulatory authorities, including the EMA, FDA, and MHRA.
Post-Authorization Translation Services We Provide.
Batch Record Translation
- We can implement our custom AI to handle almost any format, including handwritten. And with 20+ years of experience, we’re more than familiar with the shorthands and specificities of terminology use in batch records.
Supply Chain and Distribution Translation
- We can translate guidance to ensure your supply chain adheres to Good Distribution Practice standards, and help keep you on top of regulatory and local changes.
Pharmacovigilance Report Translation
- Working with our in-country linguists, we can help you communicate meaningfully and clearly with patients and HCPs in all languages and cultures, to ensure safety and avoid misunderstandings.
Adverse Event Report (AER) Translations
- Large volumes of data, inconsistent formats, and rapid turnarounds… We leverage AI OCR, workflows, and assisted translation to return accurate content to you in a fraction of the time.
Periodic Safety Update Report (PSUR) Translations
- We can translate this key document for regulatory bodies around the world, and can also help with any subsequent labeling updates.
Risk Management Plan (RMP) Translations
- We translate your RMPs for regulatory bodies and HCPs internationally. We can isolate updated content for translation and maintain careful version control, so all language versions remain consistently live and up to date.
How We Help You Overcome Post-Authorization Challenges.
The post-authorization stage brings complex operational, regulatory, and safety communication challenges. Conversis helps you overcome them with specialized expertise, AI-enabled workflows, and global linguistic coverage.
Safety data comes from multiple sources and formats, including handwritten and unstructured content.
How we help: We employ AI-enabled tools and expert linguists to accurately translate and standardize content across 330+ language combinations.
Adverse events and safety updates must be translated and submitted quickly to meet regulatory deadlines.
How we help: Our optimized workflows and global linguist network ensure rapid turnaround without compromising accuracy.
Managing large amounts of safety and regulatory content can strain internal resources and increase costs.
How we help: We apply scalable workflows and automation to efficiently process high volumes of content with speed and consistency.
Safety information must be communicated precisely to regulators, healthcare professionals, and the public worldwide.
How we help: Our specialist linguists in 110+ countries ensure accurate, culturally-appropriate translations that support safe and compliant communication.
Why Leading Life Sciences Organizations Choose Conversis.
Trusted by organizations all over the world
What our clients say about working with us.
Contact us to discuss how we can assist with your post-authorization translation needs.
Case Studies.
FAQs.
Before a medicine is approved, it goes through clinical trials. However, trials can’t catch everything, such as:
- rare side effects;
- long-term effects;
- how the drug performs in real-world use.
Once a drug is approved and sold globally, companies must continue monitoring safety and report their findings to regulators in local languages.
Highly-technical materials that require translation after approval include (but aren’t limited to):
- Adverse Event Reports (AERs): Reports of unexpected side effects from patients or healthcare professionals.
- Pharmacovigilance reports: Ongoing monitoring of drug safety.
- Periodic Safety Update Reports (PSURs): Regular safety summaries sent to regulators.
- Risk Management Plans (RMPs): Plans outlining how safety risks are monitored and mitigated.
- Batch Records: Definitive, chronological collections of documents detailing every action, material, and parameter involved in the production process of a pharmaceutical product.