Abbreviated New Drug Applications (ANDAs)

PharmaReg provides an end to end regulatory support for your ANDAs from strategy to submission. We provide services including authoring and review of documents, gap analysis, eCTD compilation and submission, deficiency responses.

Our Expertise Include:

• Controlled Correspondences

• Citizen Petitions

• Priority Review Requests

• Competitive Generic Therapy Designations

• Compilation and Preparation

• Labeling and SPL Creation

• eCTD Compilation and Submission

• Life Cycle Management