Services
SubmIT Regulatory Services provides a complete portfolio of regulatory and clinical services supporting the product development process.
Experts in Regulatory and Submission Management
Our regulatory team will work together with you to identify the best pathway to get your product to market. Our solution combines leading Regulatory experts with best-of-breed publishing platform. Key value-add areas include -
- Prepare, publish and compile paper and electronic submissions to national agencies in the European Union and in the US
- Agency communication management
- Regulatory Affairs consultation and gap analysis
Wide range of therapeutic areas and indications
- Oncology
- Metabolism
- Immunology
- Multiple Sclerosis
- Pregnancy prevention
- Bronchospasm
- Hematology
- Infectious disease
- Cardiovascular
Vast experience in preparing and standardizing clinical data to comply with regulatory requirements
As part of regulatory submissions, companies are required to follow CDISC (Clinical Data Interchange Standards Consortium) standards for their clinical data. Life science companies are rapidly adapting to these standards and are facing conversion challenges with their legacy studies as well as internal data management challenges with their ongoing studies given the new standards. SubmIT staff has been successfully dealing with these challenges since 1995 in multiple organizations and therapeutic areas. Key value-add areas include
- Legacy/ongoing study data conversion
- CDISC-oriented study data design
- Data Standardization Consulting
- Data Warehouse design and implementation
