Our expertise
Clinical Trial Safety Management
100%
Post-Marketing Safety Management
100%
Marketed and Investigational Product
100%
Medical device
75%
Veterinary
50%
Cosmetic
25%
Clinical trial drug safety and
Post-marketing Pharmacovigilance
management
Clinical Trial medical monitoring; study site support; training; clinical data review.
Study documents preparation; Clinical trial and Post-marketing reports preparation.
Pharmacovigilance system management; SOP preparation; Audit and Inspection support.
Operational experience in different geographical locations across globe, from reliable Pharmacovigilance experts/medical reviewers with extensive experience in drug safety, clinical trials management professionals providing our services to global pharmaceuticals, biotechnology companies and contract research organizations (CROs).
Customized business relationship as an optimized approach to serve regulatory obligations.
Accountability for quality and compliance as priority, we have organized internal ecosystem supported by experts in handling inspections, and audits.
Effective IT system complying with all applicable global and regional regulatory requirements to safeguard patient data with privacy policy.
Proactive recommendations as part of change management, boosts the adaptability of Clients to cope up with dramatic regulatory changes globally. Cross functionally, well-coordinated to communicate the safety information, and updates mutually.
A matrix of process and outcome oriented partnership with a vision of quality performance at first time.
Collaborative functioning of the internal expert team both internally and externally with awareness of cultural nuances.
Cost effective model by optimized operations to match the client expectations ensuring the quality and compliance.