Regulatory
Know-How™

Our experts understand the ins and outs of complex regulatory approval and registration processes to help you avoid pitfalls and save time and money.

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Ensuring Compliance at Every Stage

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)

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