Regulatory Services

We provide expert regulatory services to our all our clients and work in consultation with them to develop customized regulatory strategies to expedite the regulatory review and approval process across Asia Pacific region. Our regulatory team has thorough industry knowledge and hands-on experience in working with different regulatory agencies and is completely equipped to handle Investigational New Drug (INDs), ethics committees and New Drug Applications (NDAs).
 
Regulatory Services
 

  • IND/Phase I Clinical Trials
  • Phase II, III and IV clinical trials approvals for drugs
  • Pilot and pivotal studies for devices
  • Import licenses for investigational products, ancillary supplies and equipments
  • Export licenses for biologicals
  • Marketing authorizations for drugs
  • Site and product registrations for drugs and devices
  • Prepare and coordinate for New Drugs Advisory Committee (NDAC) and Medical Device Advisory Committee (MDAC) at Drugs Controller General India (DCGI) Office