The Specialty Operations Solutions (SOS) division of WorkingBuildings focuses on CGMP and GTP manufacturing facilities, and USP<797> / USP<823> compounding facilities. SOS services a wide range of client interests to include organizations from the pharmaceutical, gene therapy, bioengineering, animal health and public health sectors. We offer the following services: • All facets of CGMP, GTP, USP<797> & USP<823> program development & compliance assistance, including: - IND, BLA, NDA and ANDA development assistance - Clinical trial development and support - Development of Engineering Controls & Administrative Controls for CGMP & GTP programs - Cell therapy & regenerative medicine program and facility development - Installation Qualifications, Operational Qualifications and Commissioning - GLP and non-GLP animal model development and full service operations • Partner in Advancing Life Science Research to Clinical Trials • Facilities Project Management • Cell Therapy & Regenerative Medicine Services • Commissioning • Facility Programming and Feasibility Studies • Regulatory Pre-Inspection Preparation & Auditing and Inspection Support