More than 20+ yrs of experience in various areas of clinical reserach. We offfer services like: (1) Protocol Designing (2) Medical Writting (3) Data Management Plan Designing (4) Sample Size Calculations (5) SOP writing (6) Audits (Site selection, Site initiation, Vendor, CRO, Data Management, ISO 15189, ISO 13485, ISO 9001, GCP, GLP, GcLP, Internal & External Process Audits, TMF) (7) Project Managment for phase trials. (8) Regulatory submissions for Product Licenses (USFDA, DCGI, EU, Singapore, Bangladesh, Canada, Korea, China) (9) Internal document designing (RMP, FMEA, RCA, Audit Plan, Communication Plan, Monitoring Plans etc). (10) Training on GCP, GLP, ISO's, NDCT. (11) Regulatory audit handling training and preparation to teams. (12) Medical Writting (13) Data Management Plan Designing (14) End to end project management and submissions (15) Responding to requlatory queries.