Audits and inspections to assist industry in complying with regulations and regulatory requirements Assessment of industry practices to prevent and resolve enforcement problems and issues Design and development of production, quality control & quality assurance programs that are consistent with GMPQSR regulations, ISO requirements, and ICH guidelines Liaison with regulatory agencies, including compilation of regulatory submissions such as DMF, IND, NDA, 510k, etc. and regulatory reports Assistance in resourcing and acquisition of production equipment & laboratory instrumentation Planning and execution of equipment and facility qualifications and validations, Design of production processes and assistance with product formulations

Address: Atubra, Inc., P.O. Box 2726, Denver, Co 80201
Telephone: (303) 235-8245
Fax: (303) 235-8247
Website: http://atubra.com/