Regulatory Affairs Expertise
Translating product materials accurately is our number one priority. Our industry specialization, regulatory knowledge and terminology expertise ensures it is always done correctly and on time.
Pharmaceutical product information is vital to the safety of patients, and important to the medical professionals who inform patients about product characteristics, usage, and effectiveness. We understand the critical need for 100% accuracy and consistency when translating pharmaceutical product information, therefore we not only follow the regulated processes for conducting the translation of these materials, but we have also developed our own augmented quality control measures.
We are experts in analyzing pharmaceutical product documents, including:
- Package Insert
- Pharmaceutical Product Information
- Patient Prescribing Information
- Patient Information Leaflets (PILs)
- Common Technical Documents (CTDs)
- MSDS – Material Safety Data Sheet
- Regulatory Correspondence