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Project Management

Project Management to Overcome Leadership & Timeline Delays

Case Studies, Regulatory /

Customer Requirement  A pharmaceutical company required timely delivery of high-quality project management services without delays. The key objectives of the project were:  Ensuring on-time and quality-driven execution of regulatory submissions  Maintaining consistent project direction despite leadership changes  Managing political and time pressures without compromising project timelines  Ensuring timely submission of required documents from external stakeholders  […]

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South Koreas Regulatory Landscape for drugs

Navigating the Drug Regulatory Landscape of South Korea

Blogs, Regulatory /

With its rapidly growing pharmaceutical industry and stringent regulatory requirements, South Korea is becoming a key global player. But for pharmaceutical companies, navigating this landscape requires strategic planning and compliance expertise.  The Ministry of Food and Drug Safety in South Korea (MFDS), previously known as the Korean Food and Drug Administration, serves as South Korea’s

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pharmacovigilance approach for biosimilars market

Pharmacovigilance Approaches for Biosimilars Market Success 

Blogs, Pharmacovigilance /

The pharmaceutical field has witnessed a tremendous growth of innovation and success in the past few years. Among these advancements, biosimilars have become essential for improving patient access and reducing the cost of therapies. The complexities that even a slight manufacturing differences can lead to variations in protein structure, post-translational modifications, and glycosylation patterns. Since

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Global Cosmetic Regulations A Guide for Cometic Products

Understanding Global Cosmetic Regulatory Standards

Blogs, Regulatory /

The global cosmetic industry is a complex and rapidly growing landscape where regulatory compliance is fundamental in ensuring product safety, efficacy, and market access. As cosmetic products cross borders, manufacturers must comply with country-specific regulations from ingredients safety to product labeling. These regulations protect consumers and set the standards that businesses must follow to enter

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Insights of Vaccine Lifecycle Management

Insights into Vaccine Lifecycle Management

Insights /

Vaccines are an indispensable element of modern public health, playing an essential role in preventing infectious diseases and saving millions of lives annually. But at the core of any successful immunization campaign is an intricate multi-stage process known as Vaccine Lifecycle Management (VLM). This encompasses everything from early research and development (R&D) through post market

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Outsourcing MAH

How Does Outsourcing MAH Responsibilities Impact a Pharmaceutical Company’s Global Expansion Strategy?

Blogs /

Marketing Authorisation Holder (MAH) refers to a person or company that has been granted permission to market a pharmaceutical product within a specific country. MAHs are subject to a number of regulatory requirements and ensure pharmaceutical products meet stringent safety and quality standards. As regulatory frameworks are becoming more stringent, many companies are turning to

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Digital Revolution on Pharmaceutical Industry

Impact of the Digital Revolution on Pharmaceutical Industry

Blogs, Regulatory /

The pharmaceutical industry, long characterized by traditional research and manufacturing practices, is currently undergoing a profound revolution. Led by advanced analytics, artificial intelligence (AI), blockchain, and other cutting-edge technologies, digital innovations are revolutionizing drug discovery, manufacturing, marketing patient care services and regulatory oversight, with real world examples and extensive research supporting these changes. This blog

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Regulatory Compliance Pathway in the Middle East

Insights into the Pharmaceutical Regulatory Framework of the Middle East

Insights, Regulatory /

Middle Eastern pharmaceutical companies are increasingly prioritizing innovation, amid significant regulatory reforms and harmonization efforts. The region encompassing a diverse range of countries, presents both challenges and opportunities for companies aiming to enter these markets. In this Blog, we explore the key elements of the evolving regulatory frameworks in middle east. Fragmented and complex regulatory

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Veterinary Regulations

Navigating Challenges and Future Opportunities in Veterinary Regulations

Blogs, Regulatory /

The field of veterinary medicine is rapidly advancing, driven by new therapies and technologies as well as increasing public health concerns about antimicrobial resistance (AMR). Regulatory agencies around the world–such as FDA, EMA and regional bodies–are adapting quickly to these changes, with regulatory frameworks constantly adapting to ensure veterinary medicinal products (VMPs) meet stringent safety

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Malaysia Pharmaceutical Regulatory Pathway

Understanding the Pharmaceutical Regulatory Landscape of Malaysia

Blogs, Regulatory /

Malaysia’s pharmaceutical industry is a rapidly growing sector, driven by increasing healthcare demands, advancements in medical research, and government support. For pharmaceutical companies looking to enter the Malaysian market, understanding the regulatory framework is crucial. The National Pharmaceutical Regulatory Agency (NPRA) plays a key role in overseeing drug approvals, quality standards, and compliance with national

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