Citra BioConsulting Information

Citra BioConsulting is a cell therapy and biologics development consulting firm providing valuable support in the areas of business and technical operations. We bring over 50 years of experience in the development of cell therapeutics, having successfully advanced multiple programs to the clinic while achieving significant manufacturing, clinical, and regulatory milestones. We strive to be your partner to advance the development of your therapeutic by working with you and for your cause by providing comprehensive support for timely and cost-effective commercialization, avoiding the need to hire multiple high-level executives during the early stages of development. Here are some of the services we offer: Technical operations: • Process development and scale-up, • Analytical method development & qualification, • CDMO selection and oversight, • Technology transfer and GMP manufacturing, • Supply chain management, • Project Management, • Quality systems, • Clinical trial support, • Regulatory affairs Preclinical development: • Strategic planning for IND readiness, • Design and execution of proof of concept studies, • Design and execution of IND-enabling studies, • Writing of technical reports, • Selection of CRO for preclinical studies Business operations: • Business strategy and planning, • Technology and product development, • Procurement of non-dilutive government grants and contracts, • Corporate development, • Partnering and investor due diligence