Pharmaceutical and Medical Device Industry Audits
Ready to Help Meet New Challenges in a New Market
Regulatory requirements are an essential part of the pharmaceutical and medical devices industry. In the United States, the Food and Drug Administration oversees the requirements and procedures related to the field. Other major organizations in the world's largest markets include the European Medicines Agency (EMEA), and the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan.
To sell in these markets, a successful Quality Management System (QMS) Audit from one of these bodies can be the a crucial step in certification and registration of your product. In Japan, changes to the Pharmaceutical Affairs Law in 2005 made the process a requirement and an increase in QMS audits was seen industry-wide.
Audits can be conducted on paper, or on-site at the facilities of the company to ensure compliance with the market countries industry standards. In either case, an accurate and efficient translation of materials, or a knowledgeable, professional interpreter can mean the difference between success or failure to comply with regulatory requirements.
Products and Services for both Paper and On-Site Audits:
- Industry Specific, On-Site Interpreters with Proven Auditing Experience
- Interpreters for Virtually Any Language Combination (i.e. French to Japanese)
- Guaranteed Timely, Efficient, and Accurate Document Translation
Don't leave breaking into a new market up to chance. Let us help get your product certified and registered to sell.
U.S. Translation Company: Superior quality Interpretation and Translation Services in over 100 Languages!
