Recent advancements with Drug Approval applications has made it a mandate to submit Risk Management Plan or Risk Evaluation and Mitigation Strategy (REMS) documentation. Due to such advents; Medical writing and Regulatory Writing has become more complex in the contemporary times however our Regulatory Affairs and Medical Writing support teams are well versed with standard terms to follow International Conference on Harmonization (ICH), regulatory style requirements for medical publications.

 

The IRI CRO Medical Writing and Regulatory affairs team is well trained and equipped to handle the complex demands of each regulatory body for all the Phases of clinical research and all types of off patent drug submissions.

 

Our Medical Writing Team’s streamlined and systematic approach and is a result oriented approach throughout the project cycle including major aspects such as;

 

- Protocol development

- Interim Study Reports and Clinical Study Report Writing

- Ensures data quality & Acceptability

- Post database lock

 

Comprehensive Medical writing affairs services at IRI CRO:

 

Our Outstanding and Comprehensive Medical writing affairs services at IRI CRO services are offered on a stand-alone basis or as an integrated part of a clinical trial, drug development program or medical information service. Considering hand on industrial experience of the subject matter experts on board, we assure the advantages of high quality services for Medical Writing and Regulatory affairs.