A culture of excellence
Consultancy
Oniosome offers comprehensive and cost-effective quality management services (QMS) for the planning, execution and reporting of clinical research studies according to good clinical practice (GCP).
Oniosome provides tailor-made services to its clients to support continuous improvement to GMP operations, through tailor-made trouble-shooting.
Audit
Oniosome offers extensive experience in planning, coordinating, executing and reporting of all types of third party audits within the pharmaceutical and general health care sectors. We employ a team of highly experienced auditors including former British, Dutch and German Health Authority Inspectors, with worldwide exposure to EU, FDA, WHO, PIC, Chinese and Japanese standards of GMP. The focus includes and is not limited to;
Due Diligence
Audit preparation
Audit execution
Audit reporting
GMP compliance
Assessment of Gap in the system
Identification of GAPs and Corrective and perventive action
Implementation of Corrective and preventive action to fill the GAPs
CAPA review (optional)
CAPA recommendation (optional)
CAPA implementation (optional)
