We have experience walked in your shoes. Our deep and holistic understanding of the life science industry business, not just IT, puts us in a unique position to provide the exact solutions or professional services you can depend on. Our services will bring efficiency improvement, standards-alignment, and regulatory compliance to your organization.
Scope of services
- Biotech/CRO Information System Design: We are experts at designing the right information systems for small and middle size biotech or CRO companies. Contact us if you want your organization to quickly establish a secure and reliable IT system to support your operations.
- Application Development: We have extensive in-house expertise in developing user-friendly applications that are efficient and compliant to regulatory requirements. We develop custom applications in the life science industry that we believe will reduce the time and cost to bring a potential therapy to the market.
- Computerized System Validation (CSV): We apply a risk-based approach to our validation practices. Deliverables from our services include Risk Assessment (RA), Validation Plan (VP), User Requirement Specification (URS), Functional Requirement Specification (FRS), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Traceability Matrix (TM), Validation Summary (VS), Standard Operating Procedure (SOP), and Server Qualification (SQ), etc.
- SAS Server Installation and Validation: We are proficient in SAS Server installation and validation.
- Electronic Submission Gateway: If your organization wants to establish the in-house capability to submit regulatory applications electronically to the FDA, contact us.