Building Trust Through Quality and Transparency

Quality Focus

Quality is a core value of Actylis’ Business Principles and is embedded in every aspect of our operations. The highest Quality Standards are respected throughout each process, making Actylis a strategic partner for both our customers and our employees. All our employees are committed to quality being an integral part of our organization’s culture. It is the added value to our products and services that ensures both customer satisfaction and strong customer relationships.

Actylis has expanded our global manufacturing footprint with each site holding the relevant quality standards for the market segment the products are manufactured for. Our Biopharma manufacturing facilities hold all the major certifications and applicable licenses from the main accreditation bodies and agencies:

• ISO 9001:2015 certified*
• GMP and GDP EXCiPACT certified for excipients
• Health Canada Drug Establishment License for Active Pharmaceutical Ingredients manufacturing
• FDA and Health Canada audited

Actylis legacy business of global sourcing and supply, prides itself on full transparency in the supply chain, full supporting documentation and strictly adheres to pharmaceutical supply chain best practices which are vital for compliance to GMP and GDP.

Our Commitment to Compliance

Our facilities undergo regular and rigorous audits by:

• Global Regulatory Authorities Including FDA, Health Canada, and EMA, ensuring adherence to international standards.
• Accreditation Bodies Validating our certifications and quality systems.
• Customer Audits Demonstrating transparency and trust with leading pharmaceutical innovators.

These audits confirm our unwavering focus on quality, safety, and regulatory compliance, reinforcing confidence in every product and service we deliver.

Supply Chain Transparency & Traceability

• Every product is supported by a Supply Chain Statement, available upon request.
• Customers are promptly informed of significant changes through the Actylis Change Control Program.
• Our Quality Management System (QMS) guarantees products meet stringent standards of quality, purity, safety, and suitability for pharmaceutical and biopharmaceutical applications.

GDP Assurance:

• Controlled distribution practices maintain integrity and traceability throughout the supply chain.
• Our QMS drives continuous improvement, ensuring products meet the latest industry standards.

OUR ACCREDITATIONS & OTHER INFORMATION

International Standards such as ISO are instrumental in facilitating international trade. ISO 9001:2015 Quality Management System (QMS) is an internationally recognized quality management standard implemented by over one million organizations in over 170 countries globally.

Actylis is currently ISO 9001:2015 certified. Implementing ISO Certification 9001:2015 has become an invaluable asset to Actylis in enhancing customer satisfaction through the effective application of the system, including processes for improvement of the system and the assurance of conformity to customers, and applicable statutory and regulatory requirements. All areas of Actylis’s business fulfill their obligations and adhere to the official standards.

Please visit our manufacturing facility pages for site specific accreditations.

Supplier Quality

Actylis sources products only from approved facilities that meet stringent quality standards aligned with GMP and GDP requirements.

• Quality Management Systems
• Facilities and Equipment
• Material Controls
• Production Processes
• Packaging and Labeling
• Laboratory Controls

This approach ensures that suppliers supporting high-risk or patient-impacting products undergo enhanced scrutiny and oversight, while lower-risk materials follow proportionate qualification measures.

Continuous Improvement & Engagement

Actylis maintains a program of regular supplier audits and visits, reinforcing expectations for quality, compliance, and traceability. Our technically trained team—chemists, engineers, and scientists—communicates customer requirements effectively, ensuring alignment with regulatory standards and end-use specifications.

We also proactively seek new sources and products when existing suppliers fail to meet quality or delivery expectations, safeguarding supply chain integrity and customer confidence.

Samples

We will only send production quality samples to customers, and we will send lab-produced or pilot plant samples only by prior agreement. We will provide pre-shipment and co-shipment samples any time they are required. Samples will always be accompanied by appropriate Occupational Safety and Health Administration (OSHA) labels and Material Safety Data Sheets (MSDS's).

Packaging and the Environment

Actylis will promote the use of environmentally friendly recyclable packaging by our suppliers. We will endeavor to meet our customers' packaging requirements. Actylis will only use warehouses and carriers approved to handle chemicals and that have appropriate permits and licenses.