As part of our full-service offering, LSNE can assist with all of your regulatory needs — including providing access to our Type IV Drug Master File and writing support for your own regulatory submissions.
- DMF Reference
- CMC Writing
- Regulatory Path Support
- Support for FDA Inquiries or Requests for Information
LSNE’s team has more than 100 years of combined regulatory writing experience for approved submissions, across a wide range of NDA, BLA and ANDA drug products, combination products and medical devices in both the US and the EU. We can provide supporting documentation or write full CMC sections, draft agency responses on challenging chemistry or analytical questions, and deliver custom support for clients, based on specific needs.
And since it’s all done in-house — by specialists with deep knowledge of the facilities and direct experience with your product — we can handle your project quickly, efficiently and with a minimum of complications. The first time.
- Access to Type IV DMF for our multi-product aseptic facility
- Detailed information to support early phase or mature products
- Additional downstream services for manufacturing programs
- Support for submissions to US, EU and other regulatory agencies