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Navigate the complex world of FDA regulations for food & dietary supplements. Learn about health, nutrient content, & structure/function claims for compliance.

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Explore Saudi Arabia's draft regulation on nutritional labeling. Learn how these new standards aim to enhance food safety and consumer awareness

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Explore the importance of compliance audits &verification in maintaining product safety & market access. Get insights on regulatory compliance, risk mitigation.

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Understanding China’s Daily chemical products regulations

China's regulatory framework for daily chemical products is an important reference point for manufacturers aiming to meet  product compliance requirements for products and earn consumer trust. Daily chemical products that form an integral part of modern life,  product compliance for personal care, and  both consumers and market access ensure consumer safety.  Daily Chemical Product Definition Daily chemicals are associated with a wide range of chemical formulations used in personal care, hygiene, cleaning and other daily activities. These include shampoos, soaps, detergents, toothpaste, skincare products and disinfectants. These products are developed to meet strict chemical quality control and security standards and are essential to maintaining the health and hygiene of households, employment and public spaces.  These products include: Cosmetics: shampoo, skincare products, perfumes, toilet supplies. Disinfectant products: disinfectant, sterilizers, disposable medical objects. Household chemicals: cleaning agents, inner homes, scrub creams,  polishing products. Personal Hygiene Articles: Articles such as hygiene napkins, diapers, and other  hygiene products. Each category includes its own regulatory requirements to ensure security, effectiveness and quality.  Understanding the regulatory framework China China's regulatory structure for daily chemical products is based on  laws, technical standards and management guidelines. These regulations define how products are registered, checked, and brought to the market. Key components of the regulatory framework include: Risk-based product classification The regulatory framework divides products into three risk categories, which requires coordinated compliance efforts. Essential product identification requirements China Labels play a central role in compliance with regulations. Clear and accurate labels not only provide consumers, but also imply compliance with Chinese regulations. All products must include: Product Name: Clearly identifies the product's purpose and properties. Manufacturer details: The manufacturer's name and address  including import/export information for international products. Active Ingredients: Mark the major components of disinfectants or functional products, especially those of disinfectants. Using Instructions: Enter correct instructions for safe and effective use of the product. Warnings and Precautions: Add information about potential dangers and steps to prevent abuse. Shelf  and batch count: Ensures traceability and clarity related to the product process. These label standards ensure transparency and allow consumers to make well-discovered decisions when using their products.  Chemical Product Registration Simplification of Chinese Manufacturers For businesses looking to expand into the Chinese market, meeting the national regulatory requirements can be difficult. With his expertise in regulatory issues, Freyr Solutions provides extensive support for the entire compliance process in China's regulatory advice. From implementing gap analysis to preparing registration documents and managing monitoring according to the market, Freyr ensures that manufacturers keep complex regulatory frameworks seamless. By focusing on all the detailed documentation, Freyr will help build trust with permissions, security assessments, labels, businesses and consumers, while also helping to secure market position in China.

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Freyr Submits 400+ HBEL (PDE/ADE & OEL) Reports in 2024

Freyr is pleased to announce the feat of delivering 400+ Permitted Daily Exposure (PDE) or Acceptable Daily Exposure (ADE) reports in the calendar year 2024. The submissions also included standalone Occupational Exposure Limit (OEL) reports and combined PDE/ADE and OEL reports for more than twenty-five (25) global pharmaceutical companies. The ADE/PDE values are used in the calculation of cleaning limits in the pharmaceutical cleaning validation process. With the recommendation on the requirement of PDE/ADE determinations to be based on a health-based approach by EMEA and other Regulatory agencies, there is high demand for good quality ADE/PDE assessment reports in the pharma manufacturing world. Similarly, OEL values help ensure the occupational safety of the workers in the pharma manufacturing setup. The determination of ADE/PDE and OEL values requires a great understanding of pharmacology and toxicology, along with expertise in pharmaceutical risk assessment. Therefore, Regulatory agencies insist on the scientific credentials and experience of toxicologists involved in drafting and approval of ADE/PDE and OEL reports. Freyr’s highly experienced and qualified toxicologists (Diplomate American Board of Toxicology and European Registered Toxicologists) have developed and submitted 400+ ADE/PDE and OEL reports for 25+ global customers from various countries like the US, UK, EU, Australia, Japan, South Korea, Egypt, Indonesia, Malaysia, Bangladesh, and India. Freyr does not sell or encourage readily available ADE/PDE or OEL reports but always customizes its ADE/PDE or OEL reports with the latest data/information as of current. In addition, Freyr toxicologists have also supported the customers in their cleaning validation, including handling audit queries related to ADE/PDE assessment at no additional cost. With its customer-centric approach, Freyr has been proudly serving more than 150 pharmaceutical companies across the world in their ADE/PDE or OEL and other toxicological risk assessment requirements for several years. Freyr has a 20+ highly qualified and experienced team of nonclinical experts and toxicologists dedicated to supporting Regulatory toxicology and nonclinical writing activities. “We are delighted to announce the successful submission of more than 400+ PDE/ADE & OEL reports in 2024,” said Satyanarayana Krishnamurthy, Senior Vice President and Head of Medicinal Products Division at Freyr. “With these consecutive submissions, Freyr has once again proved as one of the most preferred partners when it comes to risk assessment reports,” Satyanarayana added. Acknowledging Freyr’s expertise in ADE/PDE and OEL services, one of our US-based generic pharmaceutical clients responded, “Awesome, great work Freyr toxicology team. Thanks for all your help and support in delivering high-quality PDE reports within a short time”. About Freyr Freyr is one of the largest, global, Regulatory-focused solutions and services companies for 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. 1650+ global customers and growing 2100+ in-house Regulatory experts 850+ in-country Regulatory affiliates across 120+ countries ISO 9001 Certified for strong process and quality management ISO 27001 Certified for information security management, state-of-the-art infrastructure

Link: https://www.freyrsolutions.com/press-releases/freyr-submits-400-hbel-pdeade-oel-reports-in-2024

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Navigating Biocide product registration South Africa: Key Insights

Registration of biocidal disinfectants in South Africa is an important process that ensures that your product is safe, effective and compliant with national regulations. This guide explains the key steps in the registration process, the necessary documentation and labelling requirements. Regulatory Framework Registration of biocidal disinfectants in South Africa is subject to a framework made up of various regulations and standards. The most important regulations to know about are: Biocides Act No. 36 of 1947: This Act regulates the registration of pesticides and biocides. SANS Standards for Biocides: Compliance with  South African National Standards for Biocides (SANS) is mandatory to ensure the safety and effectiveness of your product. Understanding these regulations is important to ensure your product meets all legal requirements before placing it on the market. Key Steps for Registration The process of registering a biocidal disinfectant in South Africa involves several key steps:  South African Biocidal Product Assessment: Conduct a thorough assessment to ensure your product meets safety and effectiveness standards. South African Biocide Documentation: Collect all required documentation, including safety data sheets, efficacy data and formulation details. Application Submission: Send the completed application along with the required documentation to the relevant supervisory authority. Review Process: The regulator reviews the application to ensure  all criteria are met. Approval and Registration: Once approved, your product will be registered and available for sale in South Africa. Key Documents Required To ensure the registration process goes smoothly, make sure you have the following documents ready: South African Biocide Safety Data Sheets (SDS): These contain information about the hazards associated with your product. South African Biocide Efficacy Data: Evidence  that the product is effective in killing or inhibiting harmful microorganisms. Biocide Formulation Details South Africa: Detailed information about the ingredients used in  biocide disinfectants. Label Information: Your proposed label must meet specific requirements from regulatory authorities.  Biocide Labelling Requirements in South Africa Proper labelling is important for compliance and consumer safety. The label should include the following: Product Name: State the name of the biocide disinfectant. Active Ingredients: List all active ingredients and their concentrations. Directions for Use: Provide clear instructions on how to use the product safely and effectively. Hazard Symbols: Insert appropriate hazard symbols in accordance with GHS (Globally Harmonised System of Chemicals) guidelines.  Ensuring  your product's label meets these requirements is key to successful registration. In summary, registering a biocidal disinfectant in South Africa requires navigating a complex regulatory environment. Understanding the key steps, preparing the necessary documentation, and complying with South African biocide labeling requirements can help manufacturers  successfully bring their products to market. If you need help during this process, consult with a regulatory expert like Freyr, who can provide valuable advice tailored to your specific needs.

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ESG Reporting: Key Strategies for Corporate Sustainability

 ESG Reporting Guide: Promoting Sustainability and Accountability Environmental, Social, and Governance (ESG) reporting has become an important aspect of corporate social responsibility, bringing transparency and accountability to an organization's sustainability efforts. By implementing ESG reporting, companies can not only meet legal requirements but also demonstrate  ethical practices and commitment to protecting the environment. Here we provide a detailed overview of the key steps and considerations for ESG reporting. The growing importance of ESG reporting ESG reporting enables companies to disclose their impacts on environmental, social, and governance aspects. It serves as an important tool for stakeholders such as investors, customers, and regulators to evaluate an organization's sustainability efforts. Increasing consumer demand for responsible practices and strong regulatory ESG frameworks further highlights the need for a comprehensive ESG strategy. Key steps in ESG reporting Understand ESG reporting requirements Companies must first identify the relevant regulatory frameworks and voluntary standards that apply to their business activities. The most important frameworks are: Develop an ESG strategy Developing a sustainability strategy  involves developing a robust ESG strategy, which includes conducting a materiality assessment to identify the issues that are most important to stakeholders and the company. Based on these insights, clear goals and key performance indicators (KPIs) should be set to measure and track progress over time. Collect and manage ESG data Accurate and reliable data is the foundation of ESG reporting. Organizations should collect data in several categories, including: Environmental: carbon emissions, water consumption, waste management  Social: workforce diversity, labor practices, community engagement  Governance: business ethics, board diversity, risk management   A robust data management system is essential to ensure quality and consistency.  Report Structure and Design ESG reports should be structured to align with the chosen framework. A clear, concise and comprehensive format is essential for effective communication. Involving stakeholders during the reporting process ensures that the final document addresses their concerns and expectations. Assurance and Validation To increase credibility, companies may consider obtaining third-party assurance for their ESG reports. Independent verification increases the reliability and credibility of  the disclosed information. Communicating the ESG Report Once completed, the ESG report should be published on the organization's website and distributed through various channels such as press releases, investor meetings, and social media platforms. Proactive communication ensures that stakeholders are well informed about the company's sustainability efforts. Benefits of ESG Reporting There are several benefits to ESG. By implementing a comprehensive ESG reporting process, organizations can: Improve market access by adapting to global regulatory standards. Improve your reputation and build stakeholder trust. Identify areas for innovation and competitive advantage. Ensure compliance with ESG regulations and minimize the risks associated with non-compliance and unsustainable practices. Partner with Freyr for ESG excellence Freyr Solutions offers comprehensive expertise in sustainability and ESG reporting to help companies stay ahead of the evolving regulatory environment. Freyr provides end-to-end support for your ESG initiatives, from collecting ESG data  and structuring ESG reports, to third-party assurance and stakeholder engagement. Leveraging Freyr's expertise, companies can produce accurate, reliable and impactful ESG reporting, setting them on the path to long-term success in a sustainability-driven world. If you'd like to learn more about how we can support you in your ESG journey, contact Freyr today.

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Explore the EU regulatory landscape for environmental risk assessments of pharmaceuticals. Learn about key requirements, guidelines, and compliance strategies.

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A Guide to Cosmetic Regulations in Chile for Global Brands Explore our detailed infographic on Chile's cosmetic regulations, covering mandatory labeling, product registration, & safety standards for the cosmetic industry

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An Overview of Cosmetic Regulations in Singapore Discover key regulations for cosmetics in Singapore. Learn about HSA guidelines, ASEAN Cosmetic Directive, and product registration to ensure compliance Cosmetic safety Singapore, Singapore cosmetic packaging, Singapore market entry, Singapore cosmetic trends, Singapore cosmetic approvals, Singapore cosmetic industry growth, Cosmetic documentation Singapore

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Freyr Solutions Embraces the Spirit of Giving During Joy of Giving Week with CSR Initiative for Aadarana Trust Children 

Donation Drive and Festive Celebration at Aadarana Trust Underscore Freyr Solutions’ Commitment to Community Support and Compassion 

HYDERABAD, [October, 2024] — Freyr Solutions, a global provider of regulatory solutions and healthcare technology, is humbled to share the success of its recent corporate social responsibility (CSR) initiative in celebration of the Joy of Giving Week. With heartfelt support from the Freyr Family, the company organized a donation drive for Aadarana Trust, a local nonprofit dedicated to supporting children from underprivileged backgrounds, reflecting Freyr’s commitment to nurturing community bonds through acts of kindness. 

Throughout this meaningful event, Freyr Solutions’ employees came together to donate essential grocery items to the children of Aadarana Trust, forming the primary contribution. Additionally, the company presented a laptop and school supplies to support the children’s educational needs, and a pre-Diwali cake-cutting ceremony added a festive touch, bringing smiles and warmth to everyone involved. 

“At Freyr, we believe in the importance of compassionate corporate engagement that can foster a positive difference in our communities,” said Ganesh Parkar, Chief Operations Officer at Freyr Solutions. “The dedication and spirit of our employees have shown that small acts of giving can bring joy and create meaningful connections within our communities.” 

Leadership members from Freyr Solutions, including Ganesh Parkar (Chief Operations Officer), Sudheer Goparaju (Senior Vice President, CON), Rehaman Abdul (Senior General Manager), and Dr. Vishnu Mohan (Vice President, MDV), attended the event in person, further underscoring Freyr’s dedication to community service. Their involvement highlighted Freyr’s commitment to cultivating a culture of empathy and support. 

Freyr Solutions remains committed to supporting initiatives that align with its values and mission to make a positive, sustainable impact. Through ongoing CSR efforts, the company hopes to encourage others within the industry to consider community engagement as an integral part of their corporate ethos. 

About Freyr Solutions 

Freyr Solutions is a leading global regulatory solutions and services company, supporting life sciences organizations in navigating the complexities of regulatory compliance. With a focus on quality, innovation, and global reach, Freyr Solutions provides comprehensive solutions that enable companies to bring products to market while meeting regulatory standards. The company’s commitment to corporate social responsibility reflects its mission to foster positive change within the industry and the communities it serves. 

14+ years in the life sciences regulatory landscape. 

1650+ global customers and growing. 

2300+ in-house regulatory experts. 

Global presence across 25+ countries. 

850+ in-country regulatory affiliates across 120+ countries. 

ISO 9001 & ISO 27001 Certified. 

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Freyr SUBMIT Pro is one of the best eCTD software tool which helps Life science companies in various regulatory submissions to global health Authorities.