Regulatory & Ethics Services
Certain skills are required to obtain Regulatory and Ethics approval for observational research. One must demonstrate not only the scientific quality of the project but also that privacy protection and patients’ right will be entirely protected. In addition, study goals must be reinforced, through adapted research methodologies.
LA-SER CORE regulatory affairs experts allow us to offer clients personalized regulatory submissions from locations worldwide with 100% success of applciations.
We provide expert regulatory services at LA-SER CORE locations around the world. A dedicated team of experienced regulatory personnel allows for a personalized approach towards rendering a comprehensive range of submission-related services to all our clients. Our Regulatory Affairs expertise and knowledge of complex regulatory environment will make all the difference when submitting your clinical study for approval.
Our global regulatory services include:
- Comprehensive Regulatory Affairs coverage to assist you in formulating customized submission strategies for observational projects
- Liaison with local regulatory authorities and Ethics Committees
- Expedited and periodic safety reporting to regulatory agencies and Ethics Committees globally, thanks to our specialized electronic PV Platform and partnerships with pharmacovigilance providers or clients’ own PV teams
LA-SER CORE excels in building successful experiences with regulatory authorities. Our Regulatory Affairs team and partners at multiple locations world-wide have excellent understanding of local requirements, submission strategies and approaches for effective follow-up with regulatory agencies and Ethics Committees.