Citra Bioconsulting

Citra Bio Consulting offers Cell and Gene Therapy (CGT) drug development consulting services in the areas of preclinical development (proof-of-concept and IND enabling studies), manufacturing (process development, scale-up, contract manufacturing), quality systems, regulatory and commercialization strategies. With over 150 years of combined experience, our team augments yours to accelerate your projects from discovery to market efficiently. 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 See our website for more details.