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PDE Reports - Techsol Life Sciences

Best Practices for Authoring Permitted Daily Exposure (PDE) Reports

This white paper primarily focuses on providing comprehensive insight to pharmaceutical companies for understanding PDE report requirements and the steps involved in PDE calculation as per the EMA and FDA Q3D(R1) Elemental Impurities Guidelines.


Post-Market Clinical Follow-up

A Comprehensive Guide for Study Design, Notified Body Collaboration, Understanding Compliance Criteria and Using Best Practices for Execution Excellence Although majority of MedTech companies are aware of the EU-MDR and IVDR requirements pertaining to Labelling and Technical and Medical Device Master file


6 Critical Considerations for Modern Global Medical Information System

If you’re looking for a new Global Medical Information (MI) system, make sure you read these top six considerations from Jayne Packham, a consultant with 23 years’ experience in MI. It’s a given that a modern global MI system, should log, track and seamlessly integrate with a knowledge base of responses.