Quality & Safety

At Bluefish, we accept nothing but the utmost achievable quality and safety standards and expect our suppliers and distributors to adhere to the same high standards. Our standards are upheld through stringent policies and procedures, which are meticulously implemented and applicable throughout the product lifecycle, from development to commercialization.

Maintaining The Highest Standards

Bluefish undergoes regular inspections by the Swedish Medical Products Agency to ensure compliance with Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), and pharmacovigilance legislation (GVP). 

Bluefish is authorised by the Swedish Medical Products Agency to import, release, and wholesale pharmaceuticals manufactured within the EU or imported into the EU.

GMP is the regulatory framework that all pharmaceutical manufacturers must adhere to in order to ensure that finished pharmaceutical products possess the required identity, strength, quality, and purity, thus ensuring patient safety. GDP regulates the distribution of pharmaceutical products under controlled conditions. GVP comprises measures aimed at facilitating pharmacovigilance, or drug safety, which involves the detection, assessment, understanding, and prevention of adverse events.

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High-Quality Production

All manufacturers with whom Bluefish collaborates undergo thorough inspections by the Bluefish Quality Assurance (QA) department at regular intervals to ensure compliance with European requirements for pharmaceutical manufacturing. 

Pharmaceuticals imported into the EU undergo quality controls (analysis) at an approved European laboratory to ensure that they meet product specifications. The laboratory is inspected and approved by the local competent authority and Bluefish QA department.


Safety Monitoring

At Bluefish, our Pharmacovigilance (PV) department plays a crucial role in ensuring the safety and well-being of patients who use our products - patient safety is our top priority. Our PV department works tirelessly to ensure that any potential risks associated with our products are identified and managed promptly and effectively. We believe that transparent communication and proactive risk management are essential to maintaining the trust of healthcare providers and patients.

What We Do

We follow a comprehensive process of collecting and evaluating information from various sources to detect potential safety issues.

  • Monitoring: We continuously monitor adverse event reports, scientific literature, and other relevant data sources to ensure the early detection of any potential safety signals.
  • Identifying: Our experts identify potential risks by evaluating the data and comparing it against existing safety profiles.
  • Analyzing: In-depth analysis is conducted to understand the nature, frequency, and severity of any identified risks, using advanced pharmacovigilance tools and methodologies.
  • Reporting: We ensure timely and accurate reporting of safety information to regulatory authorities, healthcare professionals, and the public, as required by EU regulations.

We Are Committed To Upholding The Highest Standards Of Drug Safety And Efficacy

We diligently fulfill all regulatory requirements to monitor the safety of our products approved for use on the European market.


Diverse Range Of High-Quality Generic Products

We are dedicated to delivering affordable and high-quality healthcare solutions throughout the EU across key therapeutic areas

Strategies & Goals

Bluefish Growth Strategy

The ongoing transformations within the pharmaceuticals industry present both challenges and significant opportunities.

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