Our experts understand the ins and outs of complex regulatory approval and registration processes to help you avoid pitfalls and save time and money.
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 Investigational New Drug Applications (IND), 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)