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CMC and Pharma Regulatory Support Services CMC and Pharma Regulatory Support Services

CMC and Pharma Regulatory Support Services

The primary objective of APSL Regulatory Services is to offer regulatory solutions that effectively address the varied regulatory requirements involved in the successful introduction of new or existing drugs into new markets or regions.

Our team of experienced regulatory scientists specialize in providing CMC services that seamlessly integrate drug development with regulatory submissions, while ensuring compliance with the latest regulatory standards. Acting as a liaison between organizations and regulatory agencies worldwide, our team serves as a vital link to facilitate successful communication and collaboration throughout the drug development process.

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Our Areas of expertise are

  • Regulatory Strategy
  • CMC Submissions
  • Response to Deficiency
  • Post approval Life Cycle Management
  • Tracking Regulatory Developments
  • Ensuring Regulatory Compliance

Why Aurigene Pharmaceutical Services?

Decades of experience in providing regulatory services

Seamless integration of DS-DP development with regulatory submissions

Ensuring 100 % regulatory compliance

4. Complying to latest regulatory requirements

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