Regulated industries such as biopharma rely heavily on accuracy and compliance. Even the smallest documentation error can delay approvals, impact market entry and affect patient access to essential therapies. A Germany-based company working in biopharma, pharmaceuticals (IV drugs and infusion therapy), medical nutrition and MedTech discovered this firsthand while preparing to register one of its medications in India.
To complete the registration process, the company needed its regulatory documents translated with absolute accuracy and certified for submission, an essential requirement for approval by Indian authorities. To move forward without delays, the company partnered with Language Services Bureau (LSB) for certified translation of its regulatory documentation. Let’s delve deeper.
The client is a globally recognised healthcare organisation headquartered in Germany, operating across several critical sectors including biopharma, intravenous drug delivery, medical nutrition and MedTech. With plans to expand into India’s growing pharmaceutical market, the company needed to complete the formal registration process required for introducing its medication into the country.
As with most regulatory pathways, this process demanded precise and certified documentation, including translation of foreign-language certificates into English.
A key document required for registration, the official registration certificate, had been issued in Russian. Indian regulators accept only English or Hindi documentation, and translations must be:
Any discrepancies could slow down approval, trigger a request for re-submission or raise concerns about authenticity.
The client needed a translation partner who understood the high-stakes nature of pharma documentation and could provide a compliant, certified translation accepted by Indian authorities.
Drug registration is a crucial gateway to market entry. A mistranslated term or an incorrectly certified document can:
In such highly regulated industries, translations cannot simply be “accurate”, they must be audit-ready, regulator-ready and risk-free.
For the client, timely entry into the Indian market depended on getting this translation right the first time.
LSB handled the project with the precision, confidentiality and regulatory awareness required for pharmaceutical documentation.
Before translating, LSB’s project team examined:
This ensured that the translation would be both linguistically accurate and regulator-ready.
LSB assigned experienced professionals familiar with medical and regulatory terminology. The translation was completed with close attention to phrasing, nomenclature and structure, ensuring every detail matched the intent of the original certificate.
Once translated, the document was:
This certification was essential for acceptance by Indian authorities.
Before delivery, the translated certificate underwent:
This ensured the translated document met all requirements for immediate submission.
With LSB’s certified translation, the client successfully completed its drug registration process in India. The document was accepted without revisions, enabling a smooth and timely regulatory workflow.
The client achieved:
For a company planning international expansion, eliminating language-related risks proved critical.
This case demonstrates a crucial truth in regulated industries. Accurate, certified translation is a strategic requirement for compliance and timely market entry. For pharmaceutical and biopharma companies, high-quality translation supports:
By partnering with LSB, the client ensured its documentation met all regulatory expectations, enabling confident entry into the Indian market.
Key Takeaways
When it comes to highly regulated sectors like pharmaceuticals, language precision directly impacts compliance and market readiness. By delivering certified, regulator-approved translations, LSB helps organisations eliminate risk, accelerate approval timelines and enter new markets with confidence.
Partner with Language Services Bureau for certified translations that support your regulatory success.
Need certified regulatory translations for pharma approvals? Call us at +91 8237060559
October 2025
