At Halden Pharma, compliance is more than meeting legal and regulatory requirements. It reflects our commitment to integrity, fairness and a working environment built on trust and respect, where everyone feels welcome and safe.
We see responsible conduct as an essential part of how we operate every day and as a foundation for transparent, reliable and sustainable collaboration.
Integrity
We act with integrity by making transparent, fair, and consistent decisions that align with our values, even in complex or challenging situations.
Regulatory Compliance
We comply with all applicable laws, regulations, and pharmaceutical standards to ensure the safe, reliable, and responsible manufacturing of products at the Halden site.
Responsibility
We take responsibility for our actions, our products, and their impact. We proactively address risks to protect people, partners, and the environment.
Respect and Trust
We foster a culture of respect and trust by encouraging open dialogue and responsible conduct when collaborating with colleagues, partners, and authorities.
Sustainability at Halden Pharma
At the Halden site, sustainability means taking responsibility for the environment, our employees, and ensuring the long-term reliability of pharmaceutical manufacturing.
We use structured processes and integrated management systems that align with ISO 9001 and the principles of ISO 14001. These systems ensure quality, safety, and responsible environmental management in daily operations.
We understand sustainability as a continuous improvement process that includes preparing for Halden Pharma’s own ISO 14001 certification by 2027. We are committed to the sustainable development of the Halden site – for now and in the future.
Standards & Certifications
Our certifications demonstrate our compliance with international GMP and regulatory standards, as well as our commitment to quality, compliance, and sustainability.
- ISO Certificate
according to DIN EN ISO 9001 - ISO Certificate
according to DIN EN ISO 13485
- GMP Certificate
according to EU GMP (EudraGMDP) - GMP Certificate
according to FDA (United States) - GMP Certificate
according to ANVISA (Brazil)
ISO Certificate
according to
DIN EN ISO 9001
ISO Certificate
according to
DIN EN ISO 13485
Meet the Team!
Meet Kristine!
Our highly skilled QA Documentation Officer at Halden Pharma. Always helpful, endlessly patient, and deeply committed to quality, Kristine ensures every change is properly documented and every process runs smoothly. Whether she’s immersed in Master Batch Records or collaborating across teams, her dedication makes a real difference. We’re lucky to have her!
I work closely with production, making sure that any changes are properly documented in our Master Batch Records. I also manage mixing specifications and act as a key user in our quality tracking system, helping ensure everything is down right without being directly involved in approvals. What I really enjoy is the balance. Some days I´m deep in documentation, other days I´m collaborating with people across production. It keeps things interesting.
Meet Kristine!
Our highly skilled QA Documentation Officer at Halden Pharma. Always helpful, endlessly patient, and deeply committed to quality, Kristine ensures every change is properly documented and every process runs smoothly. Whether she’s immersed in Master Batch Records or collaborating across teams, her dedication makes a real difference. We’re lucky to have her!
I work closely with production, making sure that any changes are properly documented in our Master Batch Records. I also manage mixing specifications and act as a key user in our quality tracking system, helping ensure everything is down right without being directly involved in approvals. What I really enjoy is the balance. Some days I´m deep in documentation, other days I´m collaborating with people across production. It keeps things interesting.
Meet Laima!
Today, we are excited to highlight our manager for QC Validation and Compliance. Whether it’s ensuring our systems meet regulatory standards or guiding the team through complex validation processes, Laima brings a calm, focused approach that keeps quality at the heart of everything we do. We’re lucky to have someone who not only knows the “ins and outs” of compliance but also genuinely cares about doing things the right way.
I manage validation and compliance in QC, covering methods, instruments, and systems, as well as leading projects for new and updated products. What I enjoy most is the dynamic environment. Every project brings fresh challenges, learning opportunities, and real growth for the whole team.
Meet Laima!
Today, we are excited to highlight our manager for QC Validation and Compliance. Whether it’s ensuring our systems meet regulatory standards or guiding the team through complex validation processes, Laima brings a calm, focused approach that keeps quality at the heart of everything we do. We’re lucky to have someone who not only knows the “ins and outs” of compliance but also genuinely cares about doing things the right way.
I manage validation and compliance in QC, covering methods, instruments, and systems, as well as leading projects for new and updated products. What I enjoy most is the dynamic environment. Every project brings fresh challenges, learning opportunities, and real growth for the whole team.
Meet Amru!
Today, we are excited to shine a spotlight on our dedicated Audit Lead at Halden Pharma. As our Audit Lead, Amru prepares and coordinates both internal and external audits, ensuring that every detail is addressed and that we meet all regulatory requirements. The importance of having a skilled Audit Lead cannot be overstated. Amru`s dedication to maintaining transparency, accuracy, and compliance helps us uphold the highest standards of quality and integrity.
As Audit Program Lead at Halden Pharma, I manage our internal Audit Programm and lead preparations for inspections by the FDA, DMP and ISO bodies like TÜV. I enjoy being around colleagues, actively involved in on-site activities while contributing to continuous improvement in compliance and operational efficiency.
Meet Amru!
Today, we are excited to shine a spotlight on our dedicated Audit Lead at Halden Pharma. As our Audit Lead, Amru prepares and coordinates both internal and external audits, ensuring that every detail is addressed and that we meet all regulatory requirements. The importance of having a skilled Audit Lead cannot be overstated. Amru`s dedication to maintaining transparency, accuracy, and compliance helps us uphold the highest standards of quality and integrity.
As Audit Program Lead at Halden Pharma, I manage our internal Audit Programm and lead preparations for inspections by the FDA, DMP and ISO bodies like TÜV. I enjoy being around colleagues, actively involved in on-site activities while contributing to continuous improvement in compliance and operational efficiency.
Meet Siv!
Today, we shine the spotlight on one of our great team members from the Quality Assurance (QA) department. With more than 37 years of experience, Siv is collaborating across various departments to ensure timely release of products to our customers.
This hands-on role operates in a fast-paced environment, collaborating with various functions, such as Quality Assurance, Quality Control, Production and Supply Chain, to ensure timely product releases to our customers. I enjoy the variety my work offers, allowing me to work independently, proactively and build strong relationships across departments.
Meet Siv!
Today, we shine the spotlight on one of our great team members from the Quality Assurance (QA) department. With more than 37 years of experience, Siv is collaborating across various departments to ensure timely release of products to our customers.
This hands-on role operates in a fast-paced environment, collaborating with various functions, such as Quality Assurance, Quality Control, Production and Supply Chain, to ensure timely product releases to our customers. I enjoy the variety my work offers, allowing me to work independently, proactively and build strong relationships across departments.
Meet Maja!
She ensures that all regulatory and internal documentation for pharmaceuticals meet the requirements of markets worldwide. She values collaboration with her skilled colleagues, something that truly drives and motivates her. Discover more about her vital role and share your thoughts in the comments!
I handle regulatory and internal documentation to ensure our pharmaceuticals and medical devices meet global requirements and guidelines. I believe no job can be done alone, so collaboration is key for me. I´m very grateful for the skilled colleagues who make this work so rewarding!
Meet Maja!
She ensures that all regulatory and internal documentation for pharmaceuticals meet the requirements of markets worldwide. She values collaboration with her skilled colleagues, something that truly drives and motivates her. Discover more about her vital role and share your thoughts in the comments!
I handle regulatory and internal documentation to ensure our pharmaceuticals and medical devices meet global requirements and guidelines. I believe no job can be done alone, so collaboration is key for me. I´m very grateful for the skilled colleagues who make this work so rewarding!