Audit, Regulatory & Quality Assurance
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
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
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