Agile Regulatory Strategies for a Dynamic Pharmaceutical Landscape

In today's rapidly evolving pharmaceutical industry, companies face unprecedented challenges in navigating complex regulatory landscapes while striving to bring innovative therapies to market. The convergence of technological advancements, changing patient needs, and evolving regulatory frameworks has created a dynamic environment that demands agility and adaptability. This blog explores how ph...

Why is Regulatory Intelligence the Key to Local PV Success?

With global health authorities continuously updating their regulations, staying ahead of these changes is vital for life sciences companies. Local PV compliance, in particular, presents a unique challenge due to region-specific regulations, reporting timelines, and stringent requirements. This is where Regulatory Intelligence (RI) in PV becomes indispensable, helping companies stay informed and...

Product Registration and Listing as per USFDA Guidelines

In the highly regulated pharmaceutical and medical device industry, Product Registration and Listing with the U.S. Food and Drug Administration (USFDA) is a fundamental requirement for manufacturers and distributors looking to introduce their products into the U.S. market. Regulatory compliance is crucial to ensure patient safety, product efficacy, and market authorization. This blog explores t...

Traditional Methods vs AI-Driven Approaches of Signal Detection in Pharmacovigilance

Traditionally, signal detection relied on manual data reviews, statistical methods, and expert assessments. However, with the explosion of real-world data and adverse event reports, Artificial Intelligence (AI) and machine learning (ML) are revolutionizing how safety signals are identified and managed. This blog explores traditional pharmacovigilance signal detection methods, the emergence of A...

What is Regulatory Labeling?

Pharmaceutical Regulatory labeling involves the creation, review, and management of critical documents that communicate essential product information to stakeholders, ensuring compliance with global Regulatory standards. Core components include the Core Data Sheet (CDS) and Company Core Data Sheet (CCDS), derived from sources such as Investigational Brochures and post-marketing data. This proce...

Toxicological approaches to deal with out of specification impurities

In the pharmaceutical industry, ensuring the quality and safety of drug products is paramount. One critical aspect of this is controlling impurities, which are unintended substances that may arise during the manufacturing process, from raw materials, or through storage. When an impurity exceeds the established specification limit, it is classified as an Out-of-Specification (OOS) impurity. Such...

China NMPA Registration

Freyr provides End-to-End Regulatory Services in China to pharmaceuticals, Medical Device, Food Supplements, Cosmetic and Consumer Companies to comply with NMPA Regulations. Freyr is a leading Regulatory solutions provider offering comprehensive services to life sciences firms across the regulatory spectrum.....

Regulatory Services in China

Freyr provides End-to-End Regulatory Services in China to pharmaceuticals, Medical Device, Food Supplements, Cosmetic and Consumer Companies to comply with NMPA Regulations. With Regional Delivery Centers, Client Servicing Centers and Offices in USA, UK, EU and India...

China cosmetic registration

Get expert guidance on China cosmetic import registration and filing. Ensure compliance with CSAR for both general and special use cosmetics. Freyr is a leading Regulatory solutions provider offering comprehensive services to life sciences firms across the regulatory spectrum....

Food supplements registration China

Get expert support for food supplements registration in China, ensuring full compliance with SAMR regulations and market entry with ease. Contact us today! China Food Supplement Regulation falls under the State Administration for Market Regulation (SAMR). The responsibility is shared between the state, provincial, municipal, and county-level authorities....

China Medical Device Registration

Freyr provides China medical device registration and approval support for device manufacturers that includes registration, classification, NMPA legal agent/representation services for product compliance as per NMPA & CMDE regulations. China is one of the fastest-growing markets for Medical Devices, where the demand for devices is majorly met through imports. ...

China Drug Registration and Approval

Freyr provides China Drug Registration and Approval support for pharmaceutical manufacturers that includes product classification, registration and approval for regulatory compliance as per NMPA regulations. As the world’s best pharmaceutical manufacturing powerhouse, China offers many business opportunities for pharma manufacturers...

How Does Ceftriaxone Injection Work in the Body?

Ceftriaxone Injection is a broad-spectrum antibiotic used to treat bacterial infections. Once administered, Ceftriaxone Injection works by inhibiting bacterial cell wall synthesis. It binds to penicillin-binding proteins, disrupting the production of peptidoglycan, a crucial component of bacterial cell walls. This weakens the cell structure, causing bacteria to rupture and die. Ceftriaxone Inje...

Brazil Drug Registration and Approval

Freyr provides Brazil Drug Registration and Approval support for pharmaceutical manufacturers that includes product classification, registration and approval for regulatory compliance as per ANVISA regulations. In Brazil drug registration and Brazil regulatory drug approval process are governed by a high-quality Regulatory system that constantly updates its standards, driven by the belief that ...

Brazil Medical Device Registration

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Brazil medical device approval

Overview The Life Sciences industry is built on innovation in terms of their constant search for new drugs, devices, and cures. Technology has become ubiquitous in driving not only scientific innovation but also in building, integrating, and managing platforms that support scientific innovation. At Freyr, we understand global Regulatory requirements management and its impact on day-to-day Regul...

Food Supplements Regulatory Services Brazil

Freyr provides food regulatory services in brazil for food supplements span across product registration, classification, label, claims review, formulation review/ingredient assessment, gap analysis and dossier compilation as per ANVISA regulations for compliant market entry....

Cosmetics product registration in Brazil

Freyr provides cosmetic product registration with ANVISA for cosmetic product registration, classification, notification, clams review, label translation, regulatory consulting, and ingredient analysis as per ANVISA regulations for compliant market entry....

Drug Registration process in Brazil

Freyr Solutions provides the best drug registration process in brazil and all kind of regulatory requriements. And  ensures compliance and smooth market entry with tailored solutions for the Brazilian pharmaceutical industry. Freyr is a global Regulatory leader providing services and solutions to life sciences companies. With a strong Regulatory knowledge base across 120+ countries, we sup...

Regulatory Strategies for Combination Products: Navigating Complex Pathways

Combination products, which integrate drugs, devices, and/or biological products, have revolutionized healthcare by offering innovative therapeutic solutions. However, their unique nature presents significant Regulatory challenges. This comprehensive guide explores the intricate landscape of combination product regulation and provides strategies for successfully navigating these complex pathway...