Our team of regulatory experts are dedicated to help our customers with regulatory questions and to support them with their regulatory submissions. They are active members in AFNOR, DIN and ISO committees as well as contributing to the main expert groups and consortia (EPAG, IPAC-RS and others).
Aptar Pharma has over 20 years of experience in active regulatory support. We have established 30 DMFs with USA FDA and partnered more than 30 successful NDAs and ANDAs.
We support your conformity assessment by providing the required documents for the materials used in our systems. We can assist you in establishing contacts to resin manufacturers. Aptar Pharma maintains a range of Drug Master Files with the US FDA and Health Canada. These are constantly monitored and updated. LoA’s are provided upon request.
Regulatory texts, standards and guidances applicable to our drug delivery devices are numerous, evolving and complex to apply. We are experts within this stringent regulatory environment and make sure our team stays sharp on key topics including material compliance and controls device and drug product development and manufacturing regulations such as Quality by Design, Combination Products, etc.
Most of our products are regulated as device components of combination drugs.
Aptar Pharma has prepared and keeps updating fast approval data packages to support customers’ speed-to-market on a global basis.