Regulatory Affairs

Effective, Reliable, Sequencing the Technology

I did QA/QC Welding and Piping from TWG Institute and i must say, i was overwhelmed by the teaching i received. it was off the chain. Highly qualified and experienced sir taught me and i really enjoyed. after completion of the course i never felt i was engaged in it for 25 days.
I did QA/QC Welding and Piping from TWG Institute and i must say, i was overwhelmed by the teaching i received. it was off the chain. Highly qualified and experienced sir taught me and i really enjoyed. after completion of the course i never felt i was engaged in it for 25 days.

Introduction to Global Regulatory Authorities for pharma and healthcare industries
Drug Development Process
Clinical Trials and related norms and regulations
GMP
Other good practices
Documentation of drug trials and regulatory filings in:
- US, EU
- India, Japan, Canada
- Australia, South Africa, etc.
Quality Assurance and Drug Regulations
ICH and WHO guidelines
Dossier preparation in CTD format
eCTD submissions
Healthcare Industry IPR
Patents, copyrights and Trademarks
Pharma and Healthcare products
- Marketing, Import and Export regulations
Compliance guidelines
Health authorityAudits (FDA, MHRA, PMDA, TGA, DCG, etc)
Breach reports
Industry specific case studies

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+91 40 2323 8040
+91 8099928580/82/79/78/77/76
info@technoworldgroup.com