Regulatory Affairs Expertise
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. 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.
We are experts in analyzing pharmaceutical product documents, including:
- Packaging
- Labeling/SmPCs
- Package Insert
- Pharmaceutical Product Information
- Patient Prescribing Information
- Patient Information Leaflets (PILs)
- Common Technical Documents (CTDs)
- MSDS – Material Safety Data Sheet
- Regulatory Correspondence