Services

Our core pharmaceutical regulatory affairs expertise is in the following areas:

• Registration of foreign manufacturing plants and drugs including the following:
  • API
  • Formulation (including vaccines, rDNA products, blood products)
  • Medical devices
  • Diagnostics kits
• New drug approval for the following:
  • API
  • Formulation
  • Medical devices
  • Diagnostics kits
• Clinical Trial Approval
  • Phase I for Indian Discovery
  • Repeated Phase I
  • Phase II
  • Phase III
  • Phase IV
• Safety Reports Updating
• Import Licenses and permits for commercial and experimental use
• No Objection Certificate for conducting BA/BE studies
• Export permission/permit for Biological Samples from Directorate General of Foreign Trade,/Ministry of Commerce
• Clinical Trial Protocol Amendments Approval
• No Objection Certificate for export of Unapproved/Banned drugs

We are proud to be rated as a top pharmaceutical regulatory services consulting company in India. Our clientele includes:

• Pharmaceutical Multinationals
• Biotech Multinational
• Medical devices Multinationals
• Diagnostics Multinationals
• Indian Pharmaceutical Companies
• Contract Research Organization
• Govt and Semi-Govt Organizations

We have been extremely successful in retaining most of our clients and we are known for solving and working on most complicated regulatory issues with highest level of confidentiality.

Our major strengths are:

• Strategizing the regulatory pathways on timescale
• Capturing the exact pharmaceutical regulatory requirements
• Building up the state of the art regulatory dossiers
• Excellent professional contacts with regulatory bodies of India
• In-depth understanding of regulatory requirements on specialized product viz combi vaccines, new rDNA based products, and new medical devices.
• Extremely competent human resources pool
• In-depth understanding of drug related laws