The regulatory considerations for non-interventional studies are complicated by the fact that each country has it’s own classification, notification and approval requirements.
Stand-Alone NIS Regulatory Services
We address this challenge by developing a Late Stage Submissions Plan for each study we support. The support provided can either be as stand-alone regulatory services or as a full service provider, thanks to our strategic partnership with the Late Stage Division of inVentiv Health Clinical
Study-Specific Late Stage Submission Plan (LSSP)
This is a key tool in ensuring compliance with the regulatory requirements for the planning, conduct and reporting of non-interventional studies.
Furthermore, the LSSP provides project team members, including affiliates, with up-to-date, detailed and accurate information on the country-specific requirements and considerations for that particular non-interventional study.
If you would like to know more about our Late Stage Submission Plans, or would like to receive a redacted example then please email me at:
firstname.lastname@example.org or email@example.com