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Pharma & Biotech

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

Supply Chain and Distribution Translation

Pharmacovigilance Report Translation

Adverse Event Report (AER) Translations

Periodic Safety Update Report (PSUR) Translations

Risk Management Plan (RMP) Translations

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.

Challenge: Complex, inconsistent data formats

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.

Challenge: Time-critical safety reporting

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.

Challenge: High volumes of multilingual documentation

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.

Challenge: Clear communication across global stakeholders

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.


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Sector experts for 20+ years
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3,000+ native-speaking in-country linguists
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110 countries
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330+ language combinations
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Work with 18/20 top pharma globally
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Track record in 50+ therapeutic areas
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Cover the entire pharma & biotech lifecycle
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Linguists are subject-matter experts
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ISO 9001, 17100 & 27001 certified
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Custom AI for post-authorization needs

Trusted by organizations all over the world

Johnson and Johnson
Merck
TMC
Roche
Immunic
Sanofi
Abbvie
pharming
pfizer
kyowa-kyrin
Bayer
Bristol Myers
MeiraGTx
AstraZeneca
novavax logo
Takeda
glaxosmithkline
huvepharma
orifarm
OM Pharma

What our clients say about working with us.

Conversis is a great partner to work with. They are extremely responsive and accommodating from start to finish. They provide a high-quality service and enable us to hit deadlines for important clients. We consider them one of our trusted partners, and they have never let us down.
Project Manager at Langland
The quality of the translation is excellent (and I am not easy to please). Thank you for your high standards.
Regina Jakacki; Chief Medical Officer; Pinion Immunotherapeutics
I can't thank the Conversis team enough for their support, professionalism, and collaboration
Meyer Gladstone; Vice President, Global Customer Marketing; Novavax

    Contact us to discuss how we can assist with your post-authorization translation needs.


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    FAQs.

    Why would translation be required after authorization of a drug?

    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.

    What documents require translation after drug approval?

    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.
    Do you translate adverse event reports?
    Yes, adverse event reports are just one of the post-authorization document types we regularly translate for our clients.

    Let’s talk.

    We look forward to hearing from you.
    We look forward to hearing from you.