New Jersey, June 25th, 2025: Freyr is pleased to announce that it delivered 50+ F-value (Failed value) calculation reports for child-resistant packaging (CRP) for more than 10 global pharmaceutical companies in the financial year 2024-25.
During the packaging of pharmaceuticals, one of the key concerns is ensuring safety, especially for young children who may inadvertently ingest harmful substances. In this context, child-resistant packaging (CRP) is crucial in preventing accidental poisoning. The F-value determination process is essential to evaluating the effectiveness of child-resistant packaging. The F-value is a key metric used to assess the efficacy of child-resistant packaging. It measures how successfully a packaging system prevents children from accessing its contents. “F” value, aka Failure Value, is defined as the number of individual dose units of a drug that can cause serious illness or injury in a 25lb (11.4kg) child. For highly toxic or harmful drugs, the “F” value is usually set at F1, indicating that the child’s access to a single unit is considered a failure. Less toxic or less harmful products have a higher “F” value (for example, F8). When a child acquires access to a 9th unit in the US, a default restriction of F8 is typically adopted. The "F" value is generally calculated from F1 to F8.
Packaging manufacturers must ensure that their child-resistant packaging meets the Regulatory standards set by authorities like the U.S. Consumer Product Safety Commission (CPSC) or the European Medicines Agency (EMA). These organizations have strict guidelines on how child-resistant packaging should function, and the F-value is often one of the determining metrics used to verify compliance.
‘F-value’ calculation complies with the Electronic Code of Federal Regulations (E-CFR), Title 16 - Commercial Practices, Chapter II - Consumer Product Safety Commission, and Poison Prevention Packaging: A Guide for Healthcare Professionals, U.S. Consumer Product Safety Commission.
Freyr’s highly experienced and qualified toxicologists (Diplomate American Board of Toxicology and European Registered Toxicologists) have developed and submitted 50+ F value reports for 10+ global customers from the US, UK, and India. In addition, Freyr's toxicologists have promptly supported the customers on any queries related to F value assessment within a short time. Freyr has a 20+ highly qualified and experienced team of nonclinical experts and toxicologists dedicated to supporting all kinds of Regulatory toxicology and nonclinical writing activities.
“We are delighted to announce the successful submission of more than 50+ F-value reports for child-resistant Packaging in the last FY2024- 25,” said Satyanarayana Krishnamurthy, Senior Vice President and Head of Medicinal Products Division at Freyr. “With these high-quality submissions, Freyr has once again proved to be one of the most preferred partners when it comes to Regulatory and all the related services,” Satyanarayana added.
Acknowledging Freyr’s expertise in F-value calculation services, one of our US-based generic pharmaceutical clients responded, “Awesome, great work, Freyr toxicology team. Thanks for all your help and support in quickly delivering high-quality F-value reports.”
About Freyr
Freyr is one of the largest, global, regulatory-focused solutions and services companies in the life sciences industry. We support large, medium, and small size global life sciences companies (Pharmaceutical | Generics | Medical Device | Biotechnology | Biosimilar | Consumer Healthcare | Cosmetics) in their entire Regulatory value-chain, ranging from Regulatory Strategy, Intelligence, Dossiers, Submissions, etc., to Post-approval/Legacy Product Maintenance, Labeling, Artwork Change Management, and other related functions. Freyr is also expanding its footprint into other key areas like Pharmacovigilance.
Headquartered in New Jersey, USA, Freyr has regional offices across the UK, Germany, France, Switzerland, UAE, Canada, Mexico, Singapore, Malaysia, South Africa, Slovenia, Sri Lanka, Australia, Poland, China, Japan, and a Global Delivery Center in Hyderabad, India.
- 1800+ global customers and growing
- 2100+ in-house Regulatory experts
- 850+ in-country Regulatory affiliates across 120+ countries
- 1400+ Global Brands/ Products supported across markets worldwide
- ISO 9001 Certified for strong process and quality management
- ISO 27001 Certified for information security management, state-of-the-art infrastructure