Quality Management Support

Quality consultation for all sectors of the pharmaceutical industry.

We are familiar with the demands of the ISO standard and industry-specific demands for pharmacy, wholesaling and manufacturing operations (GxP). We can help you evaluate the effectiveness of your quality systems, update them or even create new ones.

Contact us, and together we can further develop your quality systems!

Quality and support services for pharmaceutical wholesalers

Is your company’s quality system GDP compliant? We provide expert assistance in a particular area of your operations or on a turnkey basis:

  • 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

Do you require expert assistance? Are your operations GMP compliant? Are you introducing GMP operations? Is a competent authority coming to inspect your operations? We offer you support:

  • Pharmaceutical manufacturing audits (medicinal products, sterile and non-sterile, packaging materials)
  • Creating or updating your quality system in compliance 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

We offer a wide range of tailored QA services to help to ensure safety and consistency in medicinal products and medical devices, but also in different GxP processes:

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

Global auditing

How do you find enough time and the right experts for your auditing needs? Does focusing on problem areas divert your attention from your normal operations? Do you require an independent assessment? Are your clients coming to inspect your operations?

Our experienced auditors can carry out on your behalf both pharmaceutical wholesaler and manufacturer audits, pharmacovigilance and registration audits, mock audits in preparation for official audits, and internal audits – anywhere in the world. We can identify your needs and help you to develop your processes.

GMP and GDP audits

  • We have long experience in handling distributing  pharmaceutical wholesalers audits.
  • Acting as your support during inspections by competent authority.
  • Carrying out on your behalf all audits related to pharmaceuticals production (EU-GMP, FDA-GMP, non-sterile and sterile pharmaceuticals, packaging materials, APIs and excipients). Providing you with a tailored solution that allows you to either participate in the audit with us or purchase a complete audit with reports in a turnkey package.

Medical devices

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

Food supplements and cosmetic products

  • Acting as your support during inspections by competent authority
  • Performing expert 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.

Pharmacovigilance audits

  • Auditing your pharmacovigilance systems and help you plan the required corrective actions.
  • Carrying out on your behalf pharmacovigilance audits of your subsidiaries or outsourced operations.

Regulatory audits

  • We audit the 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 and whether your operating procedures require updating.