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Regulatory Affairs

Our regulatory team provide our clients with the following services:

  • Composing the CMC and summary sections of an application (DMF, IND, ANDA, NDA, and BLA)
  • Publishing submissions in the eCTD format
  • Reviewing technical documents and/or submissions for compliance with current FDA’s expectations and regulations
  • Providing regulatory strategies on product development and manufacturing
  • Assisting in FDA meetings, and in preparation of manufacturing facilities for FDA on-site inspections