This is the basic pre-requisite to doing business in the pharmaceutical industry. Knowing regulatory requirements
and fulfilling them is essential and literally assures having the license to provide product to the customer.
In another sense the regulatory authority in the respective area is only one, yet possibly the major customer in all business relevant activities. Customers can be within the organization or external to it. Knowing the requirements of the customer and working to fulfill them is generally seen as the definition of “Quality”.
Having a high standard of quality is desirable for a successful business organization.
Services provided in this area: (individual/single projects or in more general combination)
Review and establishment of Quality System and Quality Management System
Support general work in Quality Control, Quality Assurance, and Regulatory Compliance
Quality Risk Management
Support in preparation of regulatory audits
Remediation of audit observations (e.g. 483, warning letter, etc.)
Establishment of compliant structures for parts of the organization
(e.g. lab organization, production, warehouse)
Revision of Standard Operating Procedures (SOP)
Identification of customer(s) and their requirements
Temporary representation in quality leadership functions
Scientific support in Laboratories and Lab technology for any Quality Control function
Support in final release of pharmaceutical product
Data integrity audits and support in assuring data integrity in laboratories and QA
Other services in accordance to prior joint consideration