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A small river named Duden flows by their place and supplies it with the necessary

A small river named Duden flows by their place and supplies it with the necessary

A small river named Duden flows by their place and supplies it with the necessary

A small river named Duden flows by their place and supplies it with the necessary

A small river named Duden flows by their place and supplies it with the necessary

A small river named Duden flows by their place and supplies it with the necessary

Regulatory Affairs Activities

Dossier write up
eCTD sections compilation
Post Approval Supplement Compilation and associated submission in respective countries.
End to End to Publishing activities - Globally
Regulatory Query Response
Regulatory Operation activities
Pharmacovigilance activities - Such as PADER,PBRER, RMP, xEVMPD and associated write up
Clinical and Non clinical summaries
Dossier Due diligence and gap assessment
CTD dossier compilation, write up, review , communication with country partner and timely submission of dossier into Emerging market countries.

Manufacturing License application and end to end activities includes bridging communication between manufacturing site and state FDA and CDSCO.
NOC Activities
GMP Approval of manufacturing sites
COPP approval
Wholesale license

Audit Preparation for Indian FDA and Foreign Audits(USFDA MHRA, TGA, WHO, ANVISA etc)
Audit facing and associated query response
Vendor Audits and Vendor Qualification activities
Equipment Qualification activities
Entire Management and establishment of QMS system
Designing of the documents
Site Master Plan and Validation Master Plan
Establishment of Quality Control Microbiology lab and Quality Control Laboratory
Establishment of Training Matrix to entire facility

Kemnor is one of the fastest growing pharma and techno consultancy, since 2022.

9624192717

inquiry@kemnorpharma.com

Ahmedabad