Regulatory Affairs Service

– Expert Regulatory team with proven RA expertise
– Submission forecast and planning
– Proactive and Collaborative approach
– Up-to-Date data related to region-specific legislation and Regulatory guidelines
– Evaluation of documentation on the basis of existing rules and regulations
(Bio Study Rules 2017 including quality, efficacy and safety)
and the supervision of related tasks
– Good Manufacturing Practice (GMP) Services
– Dossier preparation
– Regulatory content management