Regulatory Services
The management of Techno Export being from a chemistry and pharmaceutical background, constant technical support come as a perk to all our customers.
As an integrated service provider, we offer international companies to gain a foothold in the Indian market using us as their agent or working with us to set up their branch office in Mumbai, India.
We are able to provide services in regulatory affairs. We can assist in documentation as well as plant audit.
Our pharmaceutical regulatory services encompasses
- » Making of common technical document (CTD)
- » Making of Asian CTD for product registration
- » Making of EDMF for API
- » Making product registration dossier
- » Making site master file
- » Making plant master file
- » Conducting structure elucidation studies
- » Conducting Validation studies
- » Conducting vendor qualification
- » Replies to deficiency letter to regulatory agencies
- » Procuring reference standard samples