Biosimilars

      • Lambda has a team of Clinical Research Professionals with extensive experience in supporting development of Biosimilars for Indian and International Registration.
      • Supported development of  18 Biosimilars  for various services.
      • Services include

– Developing Regulatory Strategy for Registration

– Preparing Clinical Development Plan and Feasibility

– Developing Protocol, Case Report Form (CRF), Informed Consent Form (ICF), Investigator Brochure ( IB)

– Developing Recruitment Strategy, Monitoring of Clinical Trials, Safety Monitoring,

– Preparing Clinical Study Report

– Central Lab. facility with Immunogenicity and PK analysis capabilities

– Supporting Preparation of Regulatory Dossier