Submission Manamegent
- Planning submission environment & processes
- Analyzing & authoring content
- Submission document processing
- Dossier compilation & publishing
- Life cycle management (amendment management and agency communication)
Our teams in Israel, the US and EU have thorough knowledge of the requirements and processes used by the regulatory authorities around the world. We understand the importance of ensuring high regulatory standards while doing so in a timely manner and executed successful submissions to the FDA, the EMA and to other national regulatory authorities.
CDISC Services
As part of the regulatory submission process, companies are required to follow CDISC (Clinical Data Interchange Standards Consortium) standards for their clinical data. Life science companies are rapidly adopting to the CDISC standards not only in order to meet regulatory requirements but also to enjoy the business benefits obtained by using these standards. Our team has extensive experience in:
- Converting data of legacy studies into CDISC
- Developing CDISC best practices used by companies around the world
- Helping organizations realize the business benefits of using the CDISC standards
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