Home > Clinical Research > Regulatory affairs
Regulatory affairs PDF Print E-mail

Bringing a new product from its development upto marketing approval is an expensive and lengthy process. If unanticipated delays occur, costs in both time and money can rapidly escalate. The staff at G7 Synergon

 is well experienced to support clients through the entire drug development program, from early consultations to clinical trials and marketing authorisation submissions. Our experience in handling a wide variety of regulatory challenges helps the client to meet exigent timelines. We have the ability to provide regulatory services as a complete study management and/or as customized services.

Clinical Regulatory services include:

• Preparation and submission of Clinical Trial Agreement (CTA)
• Local accompanying of the approval process and communication with regulatory authorities
• Clinical Trial Registry India (CTRI) Entry
• Import / Export licenses from DGFT
• T - License procurement
• Approval from Genetic Engineering Approval Committee (GEAC) for Biotech products

Pharma Regulatory services include:

• Dossier Development and submission (CTD and e-CTD)
• DMF preparation
• Conversion review of old dossiers from general format to CTD format
• Import/Export licenses from DGFT
• CMC documentations and submissions
• Variation filings




 

 

News

Vaccine Industry in India – An Emerging Global Hub

Asia is emerging as the vaccine hub of the world and India is on the go to play a key role in the...

CHRONICLE PHARMABIZ

India, an emerging global hub for vaccine industry ASIA is emerging as the vaccine hub ...

RECOGNITIONS

“G7 SYNERGON has been recognized by the Department of Scientific and Industrial Research (D...

Post Marketing Clinical (PMC)

Phase IV Studies – A Market With A Proactive Approach For Growth Of A Pharmaceutical Busine...
Counter :mod_vvisit_countermod_vvisit_countermod_vvisit_countermod_vvisit_countermod_vvisit_countermod_vvisit_counter

© 2019 G7 SYNERGON. All rights Reserved