OUR SERVICES INCLUDE:
- Develop regulatory strategies and identify submission options
- Create content for all
submission types with content development services - Perform quality assurance
audits of source documents and regulatory submissions (print and electronic) - Convert submission data to CDISC formats
- Plan and prepare for regulatory authority meetings
- Prepare and file all types of applications from the investigational phase through commercialization including lifecycle updates
LIQUENT Direct®
There are numerous steps to ensure that your regulatory submission will be
accepted — get one thing wrong, and it could result in added costs and
delays to your product’s launch. LIQUENT Direct®, an extensive collection of
expert writing, outsourcing, staff augmentation, and educational services from
LIQUENT, is designed to help organizations be successful in this process.
From start to finish — from initial protocol development, investigator brochures,
report creation through submission filing — you’ll have a trusted advisor on
your side. LIQUENT’s team of regulatory experts will analyze and define each
phase of the project, allowing you to decide what assistance you need to
supplement your resources. Then, when the correct plan has been agreed
upon, we’ll develop, implement and execute it, with your sign-off at every
milestone.
LIQUENT Direct® SERVICES INCLUDE:
- LIQUENT Direct® OUTSOURCING SERVICES
- LIQUENT Direct® REGULATORY AFFAIRS
- LIQUENT Direct® REGULATORY WRITING
If you would like additional information please contact us.