Audit, Regulatory & Quality Assurance |
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K2C
provides support to Regulatory Affairs and Quality Assurance units
during the critical phases of company’s history and when extra
work has to be carried out.
Our Auditors have lead inspections on behalf of Pharmaceutical Companies to a variety of suppliers, including producers of drug raw material, APIs (Active Pharmaceuticl Ingriedents), software and equipment vendors.
We also help pharmaceutical industries to assess their compliance
status and to prepare agency
inspections.
Our services include:
Supplier Audits (API, raw materials, excipients and packaging
materials, CROs)
Supplier selection and qualification (IT products, Equipment and
Utilities
Regulatory Consultancy for DMF / eCTD preparation, update,
submission, renewal, communications with agencies (US, EU, Local)
Preparation and support for
FDA / EMEA inspections
Selection and Qualification Audit of IT/Equipment vendors
Consultancy for interpretation and application of specific standards
and regulations (GMP, GCP, GLP, GDP, ICH guidelines, 21 CFR Part 11,
Privacy, HSE, etc.)
Definition of Policies, Site Master Plans, Validation Master Plans,
User Requirements Specification
Preparation or update of company
Quality System and SOPs
GxP Assessment and Risk Analysis of production sites, products,
processes, equipment, infrastructure, and/or computerized systems