The One Stop Solution for Other Regulatory Affairs Related Services.

MASUU offers following Other Regulatory Affairs services to Pharmaceuticals (Finished Product and API), Biopharmaceutical, to Healthcare, CMO and Medical Devices industry throughout the globe.

MASSU qualified and experienced Regulatory Affairs / Operations professionals who provide one stop solution, support and services for Other Regulatory Affairs Related Services.

Other Regulatory Services

ESG, eSubmission, CESP and EDQM account setup
Secure the mail id with FDA for communication
Assist in Digital Signature implementation and execution
Assist applicant to get pre-assigned ANDA, DMF, IND, NDA, BLA and Procedure number
Regulatory guidelines consulting related to CMC, Clinical, SPL and eCTD
Assist in software validation (UAT, DQ, IQ, OQ, PQ, and VMP) process
Assist in applying and updating DUNS/FEI number
Assist in FDA dossier submission through ESG
Assist in US Agent/LTR service throughout the globe
Share Health Authority guidelines updates through newsletter mail and website blog
IPR related work (patent search, infringement strategy etc.)