Global BioSolutions Information

Through an association with several partners and associates, Global BioSolutions is able to provide expert advice on the international regulatory requirements for biopharmaceutical products including complex biological products such as vaccines, therapeutic proteins and gene and cell therapies. Our services include: Regulatory and development needs/gap analysis Preparation of global regulatory and program strategy Communication with US FDA and international regulatory agencies Pre-IND, Pre-CTA and other meetings with regulatory agencies Selection and management of manufacturing, preclinical safety and clinical research contractors Preparation of IND and clinical trial applications Preparation of regulatory documents including Investigators Brochures Expert reports Summaries of technical information Validation reports Review and comment on marketing applications Project management Updated December 08, 2005 [Home][Consultants][Services][Rates][Contact][Links]