CMC and Regulatory Support

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.

Speak to our experts

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 CMC and Regulatory Support 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

Other Services

Clinical and Commercial Packaging Services

Clinical Supplies and Commercial Manufacturing

Drug Excipient Compatibility Studies

Drug Product Characterization Studies and Testing Services

Drug Product Development

Early Phase Formulation Development

Formulation Studies

Pharmaceutical Stability Studies

Preformulation Studies

Virtual Tour

Hyderabad R and D Center

Bangalore R and D Center

Connect with our scientific experts for your drug discovery, development, and manufacturing needs

We understand that clear communication is essential to successful collaborations, and that's why we have a dedicated team that is always ready to help you. Whether you have questions about our services, want to discuss a potential partnership, or simply want to learn more about our company, we're here to help.

Our team of experts is dedicated to providing personalised solutions tailored to your unique needs. So, please don't hesitate to reach out to us. We look forward to hearing from you and helping you achieve your business goals.

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