Technical and Regulatory Services

Customer and Regulatory Support (CRS) at Aspen Oss B.V. is dedicated to provide full support to our customers worldwide for all quality, regulatory and cGMP related items.  A team of specialists will provide you as our API customer the appropriate information in due time, where we continuously strive to meet and exceed your expectations.

We have a strong history of regulatory compliance and positive relationships with the FDA, EDQM, DHA as well as other governmental and regulatory agencies. This facilitates your new regulatory application ranging from Investigational New Drug Applications (INDs), New Drug Applications (NDAs) to Abbreviated New Drug Applications (ANDAs) to ensure a smooth Marketing authorization of your Drug Product in countries around the globe.

In addition, CRS has the responsibility to maintain the compliant status of registration documentation (DMFs, ASMFs, CEP dossiers) and inform customers of updates to our files via customer notifications to ensure that your Marketing authorization is kept up-to-date.

Overview of the activities of CRS:

  • Respond to quality and regulatory questions of Aspen customers
  • Compile and submit amendments to registration documentation to health authorities
  • Respond to deficiency letters of Health Authorities related to drug substance registrations
  • Keep registration documentation up to date and notify customers of changes
  • Compile and submit registration documentation to serve customer needs to register for new applications in new countries
  • Host customer audits 
  • Setup Quality agreements

After receipt of a customer request, CRS will provide a ticket number and first response within 2 business days. For each question, a dedicated contact person is appointed to extend our professional support. The system is set up in order to bring our technical, scientific and regulatory specialists in direct contact with our customers. Some questions can be handled instantaneously, and the information will be part of our first reply. In other cases, a due date is included in our first reply.

CRS has also made a number of documents available on our Document Server, which are the direct disposal of our customers after having completed the registration form.

For more information, see http://www.aspenoss.com/login-document-server