Regulatory Support

Superior regulatory support at each stage of drug development will lead to final market approval of your product.

Beginning with material qualification at the earliest stages of device development processes: only resins from reliable suppliers and with appropriate documentation are selected and thoroughly characterized.

We at Aptar Pharma ensure that all regulatory processes will run smoothly including complete and formally correct delivery system documentation.

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.

Material changes are an ongoing issue in our industry. We make sure  all changes are managed with appropriate care, taking your interests into consideration. Selection of new material back-ups and qualification as well as an appropriate involvement of your expert teams are underlining a professional business relationship. Proper documentation is established to make sure any change runs as smoothly as possible.

Our regulatory experts are members in DIN and ISO committees who are  constantly monitoring and providing input to evolutions in the regulatory affairs environment. We interact with relevant agencies in order to be well aware of trends regarding guidelines and regulations long before these make it to the public domain. Being a well accepted manufacturer for many years, we often make contributions during the creation phase of such guidelines.

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.