Quality Management Support

Quality consultation for all sectors within the pharmaceutical industry. Biocodex Pharmaceutical and Medical Services offer you a wide range of services to support your Quality Management System. Our experts are familiar with ISO 9001 and 13485 standards and industry-specific quality standards for wholesaling and manufacturing operations (GDP and GMP). We can help you to evaluate the effectiveness of your quality systems, update them or even create new ones.

Our experienced auditors can do both pharmaceutical wholesaler and manufacturer audits, pharmacovigilance and registration audits, mock audits in preparation for official audits, and internal audits – anywhere in the world.

Quality Management Support can be tailored to your needs. Please be in touch and we’ll find the solution for you. 

Quality and support services for pharmaceutical wholesalers

  • Responsible pharmacist/deputy service or acting as a local quality contact in the Nordic and Baltic markets
  • Support in wholesale licence applications
  • Creating or updating your quality system in compliance with the GDP, ISO 9001 or ISO 13485 standards
  • Tailored training in pharmaceutical wholesale operations and quality systems
  • Local support in product complaint, product defect and recall procedures
  • Internal audits and inspection readiness

Quality services for pharmaceutical manufacturing

  • Pharmaceutical manufacturing audits (medicinal products, raw – and packaging materials) all over the world
  • Creating and updating your quality sytems in cpmliance with the GMP, ISO 9001 or ISO 13485 standards
  • Tailored training in GMP and quality systems
  • Assistance in defining your GMP level and creating an order of priorities

 Quality assurance/compliance check

  • Regular testing of company contact channels (e.g. out-of-office hours, business continuity)
  • Quality check of processes function, individual documentation, translations (documented proof reading)
  • Preparation and conducting quality/qualification questionnaires
  • Evaluation and update of Quality Assurance systems

Food supplements, cosmetic products and Medical Devices

  • Acting as your support during inspections by competent authority
  • Performing gap audits before inspections by competent authority or audits to be carried out by a partner, and we can help you anticipate the required corrective measures

Regulatory audits

  • Auditing critical processes in regulatory affairs, such as information flow and storage
  • Carrying out audits in SPC and PIL version administration and packaging materials, and we check whether national databases are up to date

Mock audits

  • A mock audit carried out before inspections By competent authority helps you ascertain the condition of your quality systems and allow you to rectify any issues before the official audit
  • Assessing whether your operations comply with current legislation

Internal audits

  • Assessing whether your operations comply with your operating procedures require updating

 

Contact us