LSNE facility

Regulatory & Quality

LSNE ensures the highest level of quality to our clients and their patients around the world. Annually, we support regulatory inspections from multiple agencies and host numerous clients and QP audits. Rest assured that our Quality Systems are current, driven to compliance, and continuously updated.

Committed to Quality

As a CDMO dedicated to quality, we work closely with our clients to provide clear and concise documentation, and we ensure that our quality systems are driven by continuous improvement.  We demonstrate these fundamentals every day with our commitment to deliver solutions that meet the most stringent regulatory compliance standards.

No matter the size of your project or organization, we provide flexible, customized solutions that produce quality products for patients in every part of the world.

Pre-filled syringe examined by manufacturing technician

Regulatory Support

LSNE can assist with all your regulatory needs including access to our Type V Drug Master File (DMF) and provide CMC writing services to support your regulatory submissions. To support your needs, we can provide supporting documentation or write full CMC sections.  Our Regulatory Affairs Team is well versed in drafting agency responses on challenging analytical questions, and in delivering custom support for clients, based on your specific needs.

We support our clients with commercial manufacturing across the globe.

LSNE supplies commercially approved medical devices to over 30 countries across:

  • North America
  • South America
  • Europe
  • Africa
  • Middle East
  • Asia

LSNE supplies commercially approved drug products to over 26 countries throughout:

  • North America
  • Europe
  • South America
  • Australia