TOPRA - The Organisation for Professionals in Regulatory Affairs’ Post

The CARA Life Sciences Platform serves not only pharmaceutical companies but a range of industries, use cases, and unique requirements. At Generis, we understand that Crop Sciences, Veterinary Sciences, Cosmetics and Food Sciences come with their own challenges and needs, all of which can be fulfilled by our Platform. CARA enables : Regulatory Excellence Seamless Integrations Security & Traceability Global Consistency Contact us today to learn more : [email protected] #cropsciences #lifesciences #regulatory #masterdatamanagement #QMS

Biotech & Pharma: Legal & Compliance Bi-Weekly News At Life Science Law, we understand that time is limited, so we have got you covered, from Artificial Intelligence to Veterinary Medicines, this is your bi-weekly update, with the key information and changes you need to know. https://lnkd.in/e_7mi2R6 #Pharma #Biotech #NewsUpdates #lifescience  

Qingdao Vland Biotech Inc. was selected as Top 100 Innovative Private Enterprises in Shandong (Ranked No.7) on July 26, 2024. And it ranked first among the shortlisted Qingdao enterprises.   Throughout the years, Vland has been committed to technological innovation with an increase in R&D investment. In 2023, the company's R&D investment accounted for 9.23% of its operating income, a relatively high level in the industry. From 2014 to 2023, the company's cumulative R&D investment accounted for 9.44% of its operating income.   Until now, Vland has established 8 technology centers and 2 labs. With the 8 nation-level innovation platforms and the IPD-based management platform, applicable research has been made in various sectors.   As of 2023, the company and its subsidiaries have been granted 390 authorized Chinese invention patents, 9 authorized U.S patents, 2 authorized European patents, 27 PCT international applications, and 39 new veterinary drug certificates (including 3 Class I new veterinary drugs). #innovations #innovation #enzymes #enzyme #probiotics #probiotic #animalhealth #animalnutrition #animals #bioengineering #biotech #biotechnology #foodandbeverage #food

Unlike humans, animals often have a cost associated with their lives, especially production animals. Farmers rarely earn enough to have expendable income. Thus cost dictates the treatment protocol for animals.  It has always been one of my passions to facilitate appropriate care for animals, and the most effective way to achieve this is by reducing the overall treatment cost. In Australia, companies can register generic formulations of products via the governing regulatory body, the Australian Pesticides and Veterinary Medicines Authority (APVMA). Generic formulations are products that contain the same ingredients as a “brand name” but are often sold at a lower price to entice customers to switch brands. When registering a new pharmaceutical product, the product undergoes chemical analysis, shelf life testing (which takes 24 months), bacteria testing, and trade impact assessment. This creates a lengthy and costly process, making it extremely hard for new companies to obtain formulations, creating a significant barrier to entry into the market before any product is ever made or sold. Thankfully, the APVMA facilitates cost-effective registration of generic formulations by reducing the requirements of tests if the product being registered exactly matches an already registered product (without patents), allowing new generic products to be created at a fraction of the time and cost. With more generic products hitting the market, the overall price of medication is driven down, making it more cost-effective for treatment. I have experienced this process firsthand when registering a generic form of lincomycin through the APVMA’s registration portal. I had to research and calculate the exact formulation of a reference product before submitting the registration for review. Since then I have successfully registered over 15 generic formulations, allowing my small company to compete in the market and offer more cost-effective treatments. #GenericProducts #Pharmaceuticals #SCIE2001 #BScUoN

💊 NAMs (New approach methodologies) are changing the way we assess the hazards of chemicals and pharmaceuticals, offering alternatives to animal testing. 🔬 They include “in silico” approaches, “in chemico” and “in vitro” assays, as well as the inclusion of information from the exposure of chemicals in the context of hazard assessment, allowing for cross-sector applications. 💡 NAMs represent a shift towards more ethical and efficient methods in chemical safety. 🖋 Chemsafe Srl experts are deeply involved in NAMs application in various areas of activity. In case of needs, do not hesitate to contact us at: [email protected]. 👀 For a comprehensive understanding, read the article down below. #NewAlternativeMethodologies #RegulatoryAffairs #Pharma #Chemsafe

What is Regulatory affairs ?? It’s a profession developed from the desire of governments to protect public health by controlling the safety and efficacy of products in areas including pharmaceuticals, veterinary medicines, medical devices, pesticides, agrochemicals, cosmetics and complementary medicines.

🚀 HERE WE GO AGAIN 13ª Ed. Esp. Medical Affairs & Medical Marketing Mais Info 👉 https://lnkd.in/gG5dqV9 #invictusciences #medicalaffairs #medicalmarketing #medical #marketing #marketacceSs #comercial #scientificadvisors #msl #regulatory #compliance #farmacia #farmaceutico #medicina #medico #bioquimica #bioquimico #nutricao #nutricionista #veterinaria #health

DO BETTER, DOSE BETTER Berry Global, Inc. GOES BEYOND DRUG DELIVERY AT #DDL2023! Meet our #OneBerry team at the #DDL 2023 conference in Edinburgh on booth 193 from December 06 to 08. At this year’s conference will be present #Inhalation solutions that deliver a better patient experience, improved adherence and better administration techniques. Meet our Berry TEAM: Arturo Cubí, Valeria Sesana, Marco Franza, Dominik Gaertig and Sanil Prasad #zerowaste #environmental #advancedrecycling #plasticwaste #packaging #plastick#chemicalindustry #healthcare #health #sustainability #future #innovation #economy #circularplastic #pharmaceuticals #packagingindustry #medicaldevices #veterinary #pharma #circulareconomy #reuse  #netzero #pharmaceuticalpackaging #sustainability #innopack #packaging #circulareconomy #recyclability #recyclablepackaging #chemicalindustry #sustainablepackaging #recyclability #packaging #sustainability #circulareconomy #recycledmaterials #resourceefficiency

NEW VICH GUIDELINE 🆕 The new #VICH Guideline GL60 on #GoodManufacturingPractice for #ActiveIngredientes Used in #VeterinaryProducts has just been released for comments. 🐶 It is very similar to #ICHQ7, applicable to the manufacture of APIs for use in human drug products, and includes the same structure and topics: ✅ Quality Management 🙋♀️ Personnel 🏭 Buildings and Facilities 🔧 Process Equipment 📜 Documentation and Records 💊 Material Management 👨🔬 Production and in-process controls 🏷 Packaging and Identification labelling of APIs and intermediates 🚛 Storage and Distribution 🔬 Laboratory Controls 👌 Validation 🔄 Change Control ❌ Rejection and Re-use of Materials 🙊 Complaints and Recalls 🤝 Contract Manufacturers 👩💼 Other agents This guideline also includes specific guidance for - APIs manufactured by #cell #culture / #fermentation - APIs used in #clinical #trials The sterilization and #aseptic processing of #sterile APIs are not covered by this guide, but should be performed in accordance with GMP guidelines for veterinary medicinal products. Comments are welcome up to March 2024, so it is time to review and comment! 😊 #regulation #biopharma #quality #compliance #lovequality