Regulatory and Quality means achieving compliance with complex regulations and meeting pre-set standards.
Typically, this must be achieved while facing organizational requirements for high quality product services supporting content contribution, consumption and distribution, all delivered by IT solutions which must be scalable, upgradeable and configurable.
By working closely with life science companies, NNIT have established valuable competencies within Regulatory and Quality processes, understanding the business drivers and the need for rigorous control of IT solutions and the processes that surrounds them.
Our expertise covers the entire enterprise content management area stretching from content capture, collaboration, authoring, approval and distribution, to electronic submissions and records management.
We have helped life science companies building solutions for:
- Content management
- Regulatory Information Management
- Physical and Electronic Records Management
- Submission Management
- Product Information Management (Packaging Materials and Product Inserts)
- Distribution and control of Standard Operating Procedures and instructions
- Patent Management
NNIT’s solutions comply with 'Good Manufacturing Practice'. And they’re based on the standard technologies and communication methods required by the regulatory bodies.