Make Quality Intrinsic with Atubra
Atubra Services
- 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 GMP/QSR regulations, ISO requirements, and ICH guidelines
- Liaison with regulatory agencies, including compilation of regulatory submissions (such as DMF, IND, NDA, 510(k), 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
- Establishment of in-house quality control laboratories or outsourcing laboratory services
- Design and establish Clinical Protocols and coordinate links with Clinical Research Organizations (CRO) and Clinical Sample Testing Laboratories
- Assistance in the development of product labeling in accordance with existing and up-to-date regulations
- Training of industry management and staff to assure full understanding of quality concepts, regulatory processes and compliance with regulations