Biju Kishor’s Post

We are pleased to announce the release of the October edition of the SeerPharma Journal, marking the final issue of the year. https://lnkd.in/emrVBAAS This publication has been distributed to Quality and Manufacturing professionals across 4,000 companies in the APAC region, all engaged in the production and handling of pharmaceuticals and medical devices. Reaching key stakeholders throughout the supply chain in our industry. We are deeply appreciative of the opportunity to serve such a broad spectrum of clients and organisations in our sector. Our 35+ years of continued growth reflect the trust placed in us and the positive impact we strive to deliver. For an overview of previous editions of the SeerPharma Journal, please visit https://lnkd.in/g24U629q As always, this edition highlights our ongoing commitment to “Advancing Quality and GMP Best Practices in the APAC region." #gmp #qualitymanagement #qualityassurance #pharmaceuticals #medicaldevices #medtech #quality #manufacturing #pharmaceutical #pharma #pharmaceuticalmanufacturing #medicaldevicemanufacturing #seerpharma

Delighted to publish the July 2024 edition of the SeerPharma Journal. https://lnkd.in/gnRjce9J This issue will be shared with Quality and Manufacturing professionals in our database, encompassing over 4,000 companies across the APAC region engaged in the manufacture and management of pharmaceuticals and medical devices. Essentially, it will reach key players in our industry's supply chain. We are truly grateful for the opportunity to serve a diverse range of clients and organisations in our sector. That we've been doing this for over 35 years, and growing, is a testament to the trust they place in us and the impact we aim to create. For an overview of previous Journal publications do visit: https://lnkd.in/g24U629q As always, the Journal shines a spotlight on how we continue to pursue our mission of “Advancing Quality and GMP Best-Practices in the APAC region" #gmp #qualitymanagement #qualityassurance #pharmaceuticals #medicaldevices #medtech #quality #manufacturing #pharmaceutical #pharma #pharmaceuticalmanufacturing #medicaldevicemanufacturing #seerpharma

Navigating Regulatory Challenges Explore how SK Pharma expertly handles the complex regulatory landscape in the pharmaceutical industry. Learn about our proactive compliance strategies and unwavering commitment to quality and safety. This is a must-read for industry professionals! #Pharmaceuticals #Compliance #Regulations https://lnkd.in/dWn7Zei5

A unique forum to discuss combination products in Europe! Here are a few topics we'll explore at 2024 Combination Products in the EU: 💡 MDR implementation status and next steps 💡 Impact of the new EU General Pharmaceutical Legislation on combination products 💡 Driving convergence on regulations 💡 Labelling 💡 Clinical trials including combination products It's not too late to join us! Book your ticket today: https://bit.ly/3QLYykh. Regulatory Affairs Professionals Society (RAPS) #DIA #RAPS #CombinationProducts #RegulatoryAffairs

There are three distinct #registration #pathway options for #active #pharmaceutical #ingredients (#API) products and #excipient and #packaging #products. Each of these #pathways carries its own set of advantages and considerations, and it is vital that applicants carefully consider them when devising their #strategies. This article from April Wang in the #April 2024 issue of #RegulatoryRapporteur discusses the advantages and challenges of the three #drug master file (#DMF) registration pathways in #China for #APIs, as well as the advantages and challenges of each approach. Read it online now 👉 https://lnkd.in/evPh5p7c #RegulatoryRapporteur is our peer-reviewed journal, published online 11 times a year and available free to #TOPRA members. This edition focuses on #data and explores how #industry is increasingly harnessing its capabilities across the #medicinesdevelopment #lifecycle to keep pace with #innovation and #digitisation. Find out more about the many #benefits of #TOPRA #membership, including access to #RegulatoryRapporteur, here 👉 www.topra.org/join

Inform your strategic decisions with unparalleled access to worldwide pharmaceutical regulatory affairs and compliance-related intelligence with Pink Sheet! Start your free trial: https://ow.ly/iiTw50SyJbL. #Pharma #PharmaceuticalIndustry #PharmaRegulatory

Entering the US Market: What Does it Take? Are you looking to expand into the U.S. pharmaceutical market? Join us on September 25th, 2024, at 11:00 AM EDT for a comprehensive webinar covering essential topics like regulatory submissions, quality management, and commercial readiness. What you’ll gain: 🔹 Insights into product portfolio analysis 🔹 Understanding of CDER’s quality framework 🔹 Effective U.S. FDA communication strategies 🔹 Commercial readiness and distribution planning Don’t miss this chance to learn the most important steps to bring drugs through U.S. FDA and into the market. Register now: 1. https://hubs.ly/Q02LPg1X0 #Pharmaceuticals #USMarketEntry #DrugDevelopment #QualityManagement #RegulatoryAffairs

We understand the challenges that pharmaceutical manufacturers face! The easiest way to overcome knowleadge gaps in pharmaceutical regulations and protocols is by partnering with a knowledge testing provider. ▶️ How do you know if you're developing the right testing program to accelerate drug development? Partner with a knowledgeable testing provider... ▶️ How do you identify a knowledgeable testing provider? Look to HMR Labs. Not only are we a completely independent business, but our employees have long-standing reputations in the field of pharmaceutical and analytical testing. This is what allows us to develop bespoke projects and customise our testing portfolio. For more information, view our bespoke services 🔗 https://bit.ly/3ORE2Pb #bespokeprojects #pharmaceuticalmanufacturers #testinglab

Having a robust QA plan in place is the cornerstone for business efficiency in the Pharmaceutical industry and beyond! Our new white paper outlines the key components of an effective QA plan, provides a detailed examination of processes and regulatory requirements, along with an explanation of the role data and technology can play. Essential reading for pharmaceutical quality professionals - download your copy today! #pharma #qualityassurance #patientsafety

🔬 **The Importance of ICH Q8, Q9, and Q10 in Evaluating Alternative Manufacturers** 🌍 In the pharmaceutical industry, ensuring the quality and consistency of products across different manufacturing sites is critical. This is where the ICH guidelines Q8, Q9, and Q10 play a pivotal role: 📋 **ICH Q8 (Pharmaceutical Development)**: Emphasizes a science-based approach to design quality into products from the start. 🛡️ **ICH Q9 (Quality Risk Management)**: Provides a structured framework to assess and mitigate risks associated with using alternative manufacturers. 🔧 **ICH Q10 (Pharmaceutical Quality System)**: Ensures robust quality systems are in place, allowing seamless integration and oversight of new manufacturing sites. By leveraging these guidelines, companies can confidently evaluate alternative manufacturers, ensuring that every product meets the highest standards, regardless of where it's made. #PharmaceuticalQuality #ICHGuidelines #RiskManagement #ManufacturingExcellence