Quality Management for all sectors within the pharmaceutical industry
Biocodex PhaMe offers 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 in evaluating the effectiveness of your quality systems, updating them or even creating new ones.
Our experienced auditors master both pharmaceutical wholesaler and manufacturer audits. In addition, our expertise encompasses pharmacovigilance and registration audits, mock audits in preparation for official audits as well as internal audits – anywhere in the world.
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 GDP, ISO 9001 or ISO 13485 standards
- Tailored training in pharmaceutical wholesale operations and quality systems
- Local support with product complaint, product defect and recall procedures
Quality services for pharmaceutical manufacturing
- Pharmaceutical manufacturing audits (medicinal products, raw materials and packaging materials) all over the world
- Creating and updating your quality systems in compliance with 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 process function, individual documentation, translations (documented proofreading)
- Preparing 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; we can help you anticipate the required corrective measures
Get To Know Our PhaMe Professionals!
PhaMe team is an enthusiastic and experienced group of professionals working with high commitment and joy.
We provide expert services more than 100 customers annually.