In order to strengthen the scientific review and approval of new drugs/devices, the ministry has appointed 12 New Drug Advisory Committee’s (NDAC), Subject Expert Committees (SEC) and 7 Medical Device Advisory Committee’s...

It is acknowledged within the pharmaceutical industry that clinical trials represent the single most expensive aspect of a drug, or treatment, development process. Specifically, clinical trials are enormously resource-intensive and involve repetitive,...

What is a New Drug as per Drug and Cosmetic Rules (D&C)? As per Rule 122 E of the Drug and Cosmetic Rules 1945, a New Drug can be – [1] A...

  We are fully experienced, and have specialized skills in providing assistance to international pharma companies who want to register their products in the USA and the European Union. We are also...

  Regulatory Affairs at US-FDA  Drug & Medical Device Regulatory Consulting CliniExperts have aligned themselves with the internationally renowned regulatory consulting companies. These companies have a proven track record in drug, medical device, and regulatory consulting...

  Zonal Licences (East, West, North and South Zone) We employ a network of specialists who are able to assist in obtaining any of the licenses or NOC's issued by the four zonal authorities in India....

The Expert Committee constituted by the Ministry of Health & Family Welfare decided that if India participates in global clinical trial for NCEs to be used for diseases prevalent in our population,...

The Expert Committee constituted by the Ministry of Health & Family Welfare decided that if India participates in global clinical trial for NCEs to be used for diseases prevalent in our population,...