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Regulatory Support

Our team of in-house compliance and validation subject matter experts offer Regulatory strategies for drug development preparation, review and submission of Abbreviated New Drug Applications (ANDA) and New Drug Applications (NDA) for a variety of dosage forms
and CMC sections.
• Electronic common technical documents (e-CTD)
  preparation and amendment
• Life cycle management for approved applications
• Regulatory assessment of post-approval changes,
  strategy and supplements
• Labeling services (ANDA)