Risk Management Plan (RMP)

The Risk Management Plan (RMP) is a stand-alone document describing your product's risk-benefit profile. It is advisable to write your RMP early in the drug development phase as a RMP may also provide a good basis for your clinical protocol and Investigator's Brochure.

Our experienced Risk Management Experts help you identify potential risks. They also advise you with regard to future risk minimisation activities other than routine pharmacovigilance for your product's entire life cycle.

For more detailed information please contact us directly. Together we will find the best solutions to fit your individual needs. 

Operational pharmacovigilance
ICSR management, EudraVigilance, RMP, CCSI, PSUR, DSUR, Signal management, XEVMPD, and many more.
Pharmacovigilance System
QPPV/deputy QPPV, SOPs, Quality Management Systems, (electronic) PSMF
Clinical trial safety
Management of SUSARs and SARs, safety narrative writing, medical assessments and DSUR
Medical Device Vigilance
Full range of medical device safety services for all different types of medical equipment
Quality Management System
Web-based quality management system software including training and document management
Audits & other support
Includes among others: ad hoc assistance, audits, training, assessment of risk-benefit, medical and scientific writing services
Pharmacovigilance related IT
PQ validations, data migrating and mapping, safety database software, EMA gateway testing
Full range of cosmetic product safety services for all different types of cosmetic products
Good Distribution Practice (GDP)
Lindeq provides GDP active substances quality system including web based QMS software (ItQMS)