- 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