May 234 min read

Understanding Regulation of Infant Formula and Follow-On Formula in the European Union

Infant nutrition is a critical aspect of early childhood development, and ensuring the safety and quality of infant formula and follow-on...

May 155 min read

Global Regulation of Infant Formulas

Infant formula plays a crucial role in providing essential nutrition to infants who cannot be breastfed, helping to support their health...

May 63 min read

Managing CDSCO registration of Multiple Product Variations of Cosmetics in India

The cosmetic industry thrives on innovation and diversity, offering consumers a wide array of products to meet their varied preferences....

May 56 min read

Understanding the State of the Art (SOTA) in Medical Device Clinical Evaluation under EU MDR

The introduction of the European Medical Device Regulation (MDR) has significantly transformed the landscape of medical device clinical...

Apr 245 min read

Role of the Qualified Person Responsible for Pharmacovigilance (QPPV) in the EU

In the intricate landscape of pharmaceutical regulation, ensuring the safety and efficacy of medicinal products is paramount. At the...

Apr 236 min read

Pharmacovigilance System Master File (PSMF) for European Medicines Agency (EMA) Medicinal Authorization Application in European Union

PSMF is mandated for all Marketing Authorization Holders (MAHs) seeking approval for medicinal products in EU

Apr 225 min read

Regulation of Nitrosamines in Pharmaceuticals

Despite the considerable efforts invested by global regulatory authorities in evaluating the safety and efficacy of drugs for their...

Apr 222 min read

New Drugs, Generics and Biosimilar Registration in Singapore: Whitepaper on HSA Regulations

Guide to regulation in Singapore, insights into regulatory authorities, registration processes, & compliance for Drugs & Biosimilar

Apr 221 min read

Artixio’s Strategic Approach to Contingent Pharma Staffing in the USA

Artixio, with its specialized focus, assists pharmaceutical organizations in the USA with strategic staffing solutions.

Apr 55 min read

CDSCO Labeling Requirements for Cosmetics in India under Cosmetic Rules 2020

Labeling plays a crucial role in the cosmetic industry, not only providing essential information to consumers but also ensuring...

Apr 22 min read

Case Study: Nitrosamine Impurities Analysis - Artixio’s Strategic Staffing Solutions for a Generic Drug Manufacturer based in the USA

Artixio helped a US based Generic Drug Manufactur with Nitrosamine Impurities Analysis through Strategic Staffing Solutions

Apr 14 min read

Obtaining Free Sale Certificate for Cosmetic Products in UAE

The UAE's strategic location, advanced infrastructure, business-friendly environment, diverse product range, adherence to quality...

Mar 312 min read

US FDA released final guidance on "Providing Regulatory Submissions in Electronic Format: IND Safety Reports."

On April 1st, 2024, the US Food and Drug Administration (FDA) introduced a significant update in pharmaceutical regulations with the...

Mar 314 min read

Pharmaceutical Regulations in Brazil: ANVISA's New Normative Ruling No. 289/2024

Brazil's pharmaceutical industry is set to undergo a significant transformation with the recent approval of Normative Ruling No. 289/2024...

Mar 294 min read

CDSCO Import Registration Number (IRN) for Cosmetics in India

The cosmetics industry in India is witnessing remarkable growth, fueled by changing consumer preferences and increasing demand for beauty...

Mar 286 min read

Global Regulation of Cultivated Meat

In the realm of sustainable food innovation, a revolutionary concept is emerging – cultivated meat. With the global population steadily...

Mar 256 min read

Advertising Permit for Cosmetic Products in the UAE

In the vibrant landscape of the United Arab Emirates (UAE), the cosmetic industry thrives, offering an array of products catering to...

Mar 224 min read

COFEPRIS Makes Changes to Revamp Medical Device Regulations

In a significant regulatory update, Mexico’s Federal Commission for the Protection against Sanitary Risk (COFEPRIS) has introduced new...

Mar 224 min read

CDSCO Regulation of New Cosmetics in India

In an era of constant innovation, the cosmetics industry is witnessing a surge in novel product development, driven by advancements in...

Mar 195 min read

Registration of Pharmaceutical Manufacturing Facilities with MOHAP in UAE

In the United Arab Emirates (UAE), the Ministry of Health and Prevention (MOHAP) plays a crucial role in regulating pharmaceutical...

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