SIPS works with EXTEDO to provide and support EXTEDO’s software in the following areas:
- Submission Creation & Lifecycle Management
- A safe and compliant submission and life-cycle management software is essential for business success in a fast changing environment with constantly evolving requirements and regulations.
- In addition SIPS provide consultation services on different electronic submission aspects, including the preparation of eCTD.
- Submission Reviewing & Validation
- The reviewing and validation of e-submissions based on a strong and reliable engine is the key for facilitating an efficient working relationship between authorities and industry.
- Pharmacovigilance Management
- Drug safety management software solution based on the E2B and MedDRA standards that enables you to classify, create, review, submit, and maintain Pharmacovigilance data and adverse event reports. In addition, it helps you to manage the life cycle of mandatory SUSAR and ICSR reports as well as all reported Serious Adverse Events (SAE) for an overall safety re-evaluation.
- Computer System Validation
- Computer System Validation is needed in many processes and aspects, to produce documented evidence which assures that the tested facilities or systems will consistently work correctly when brought into use. SIPS can help you to reach your goal of a compliant efficient computerized system by many means, including validation protocol writing and implementation, test scripts writing, disaster recovery planning, risk assessment, procedures development and review.