Enabling Innovation Through Quality Research For Furtherance Of Human Healthcare
At our company, we provide top-notch regulatory services to our clientele that results in speeding up the progress of regulatory review and approval across our regions of operations. These services are accustomed according to the requirement of the clients and are carried out with their constant consultation throughout the process. Tailor-made strategies are prepared to suit their individual needs. All of this is done through the extensive knowledge base that our regulatory team possesses and their industry experience in dealing with various regulatory agencies. Our regulatory services team is also fully able to handle Investigational New Drugs and New Drug Applications.
Regulatory services span the following activities:
- Handling phase I clinical trials
- Securing seamless approval for drugs- Phase II, III and IV clinical trials
- Model studies for devices
- Securing import licenses and export licenses for specific products
- Getting marketing permits for drugs
- Registering site and product for drugs and vehicles
- Readying and coordinating for New Drugs Advisory Committee and Medical Device Advisory Committee at the office of Drugs Controller General of India (DCGI).
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