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)