MAC Clinical Research’s Post

Streamline Your Clinical Trials with ABF Pharmaceutical Services GmbH Are you preparing for clinical trials or transitioning from preclinical development? 🤝 Partner with ABF Pharmaceutical Services GmbH to ensure your success. ABF Pharma's comprehensive services include  - GMP storage - controlled drug status - temperature-controlled transport - clinical supplies project management, and  - QP release. Further areas of specialisation are in  • kit production,  • labeling,  • packaging, and  • distribution, ensuring your investigational medicinal products (IMPs) are handled with the highest quality standards. Unlock Your Clinical Trial Potential with ABF Pharma, your trusted partner in transforming promising candidates into market-ready solutions. Learn more about our services and how we can support your clinical programs: https://lnkd.in/eFaPg5sR Get in touch to learn how ABF Pharma can accelerate your path to success and to arrange enabling support for your upcoming clinical trials and study program. M-B-V-C  marc.brehme@m-b-v-c.com #clinical #trial #study #clinicaltrials #clinicalstudies #pharma #medicalneed #innovation #translation #therapeutics #assets #drugs #APIs #IMPs #vaccines #biomarkers #PBMCs #patients #global #world #lifescience #biomedical #FDA #EMA #businessdevelopment #consulting

BPA software supports #pharmaceutical companies in adhering to strict regulatory requirements, https://lnkd.in/dVjnF4-e 💡 It helps document and manage #compliance processes, including #regulatory audits and inspections. The software assists in maintaining compliance with industry standards and regulations such as Good Manufacturing Practices (#GMP) and Good Laboratory Practices (#GLP). This ensures regulatory compliance, reduces risk, and strengthens the company’s reputation As pharmaceutical products become increasingly complex, companies can leverage new technologies in their manufacturing process to improve efficacy, https://lnkd.in/dNRmuETZ #riskmanagement #qualitymanagement #eQMS #pharmamanufacturing #medicaldeviceindustry #fda #mdr

🌐 Navigating the Regulatory Landscape: Streamlining Pharmaceutical Registration in Argentina✨ Before pharmaceuticals are made available to the public in Argentina, they must undergo a comprehensive product registration process with ANMAT. To complete this process, you must provide extensive documentation outlining the product’s composition, manufacturing processes, quality control methods, and clinical data proving its efficacy and safety. 🔍 Key Highlights: ✅ License renewal of Pharmaceutical Products ✅ Registration fees of Pharmaceutical Products ✅ Accelerating Approval Timelines Are you a pharmaceutical professional looking to expand your market reach to Argentina? 🌍 Dive into our comprehensive guide on streamlining the drug registration process, brought to you by OMC Medical! 💊📋 https://lnkd.in/gm_zrpzt #Pharmaceuticals #RegulatoryCompliance #ArgentinaMarket #DrugApproval #OMCMedical #HealthcareIndustry #GlobalExpansion #MarketAccess #IndustryInsights

In the quest to deliver quality healthcare products to patients who need them, pharmaceutical companies invest in ensuring they have the right data to support their products including, when acquiring legal authorization to market them in countries for which they are intended to be used by patients. The pharmaceutical industry is highly regulated due to the risk pharmaceutical products may cause when good standards and practices are not employed and adhered to. Dossier preparation is a comprehensive and meticulous task, requiring attention to detail, therefore, regulatory professionals, pharmaceutical and biopharmaceutical professionals require necessary knowledge, skills and competencies to perform excellently during dossier preparation, review and submission. Register and train with us on; Dossier Compilation, Review and Submission. Register: https://lnkd.in/g_9hEQS9 Date: August 17, 2024 #RegultoryAffairs #DossierCompilation

𝙉𝙖𝙫𝙞𝙜𝙖𝙩𝙞𝙣𝙜 𝙩𝙝𝙚 𝙏𝙧𝙖𝙣𝙨𝙛𝙤𝙧𝙢𝙖𝙩𝙞𝙫𝙚 𝘾𝙝𝙖𝙣𝙜𝙚𝙨 𝙞𝙣 𝙀𝙈𝘼 𝙍𝙚𝙫𝙞𝙨𝙚𝙙 𝘼𝙣𝙣𝙚𝙭 1 𝙛𝙤𝙧 𝙋𝙝𝙖𝙧𝙢𝙖𝙘𝙚𝙪𝙩𝙞𝙘𝙖𝙡 𝙍𝙚𝙜𝙪𝙡𝙖𝙩𝙞𝙤𝙣 The 𝗘𝗠𝗔 unveiled its revised 𝗔𝗻𝗻𝗲𝘅 𝟭 𝗼𝗻 𝗔𝘂𝗴𝘂𝘀𝘁 𝟮𝟱, 𝟮𝟬𝟮𝟮, marking the end of a seven-year revision process. Effective from 𝗔𝘂𝗴𝘂𝘀𝘁 𝟮𝟱, 𝟮𝟬𝟮𝟯, the new regulations introduce significant updates, including a key requirement for sterilizing manually loaded/unloaded lyophilizers before each load, effective from 𝗔𝘂𝗴𝘂𝘀𝘁 𝟮𝟱, 𝟮𝟬𝟮𝟰. The expansion to 59 pages from the previous 16-page version underscores the depth of these changes, reflecting global collaboration and the latest advancements in technology and regulatory practices. Pharmaceutical companies must adapt swiftly to maintain the highest standards of safety and efficacy in drug manufacturing. Speak Pharma #Annex1 #Lyophilization #AsepticProcessing #Compliance #GMP #GAMP5 #PharmaRegulation #SterileManufacturing #EMA #FDA #PICs #WHO #Pharmaceuticals #DrugManufacturing #QualityControl #RegulatoryCompliance #DrugSafety #PharmaTech #PharmaIndustry #ManufacturingStandards #RegulatoryGuidelines

"Thrilled to have visited SCITUS PHARMA SERVICES a leading research institute in the pharmaceutical industry! Got an inside look into their cutting-edge facilities and learned about their groundbreaking work in bioequivalence and pharmacovigilance. #Scitus #pharmaceuticalresearch #Bioequivalence #Pharmacovigilance"

Navigate regulatory outsourcing in pharma with insights from European Pharmaceutical Review. Elevate efficiency and compliance.

Partnering with a specialised safety provider can help companies set-up cost-effective and agile PV operations in a time bound manner. View our case study on how we helped a US biopharma company setup an efficient PV system: https://bit.ly/3dpSgDE #pharmacovigilance #caseprocessing #drugsafety #pharmaceutical #regulatory #riskminimization #rems #biopharma #US

Partnering with a specialised safety provider can help companies set-up cost-effective and agile PV operations in a time bound manner. View our case study on how we helped a US biopharma company setup an efficient PV system: https://bit.ly/3dpSgDE #pharmacovigilance #caseprocessing #drugsafety #pharmaceutical #regulatory #riskminimization #rems #biopharma #US

In the dynamic landscape of pharmaceutical research, maintaining the highest standards of quality and compliance is paramount. The third Party lead auditors ensures that contracted/Clinical research organizations (CROs), investigator sites/PI for clinical trials and API/ Aseptic processing places deliver output that meet sponsors/clients' rigorous requirements and satisfy regulatory agencies. Every pharmaceutical company has unique needs and challenges. That's why It is important to personalize audit solutions tailored to their specific requirements. A pre-designed audit template might not be applicable for every environment. Whether you need a comprehensive audit of all research processes or targeted assessments in specific areas, a tailored/customized approach would demonstrate auditor's commitment to quality, compliance, and ethical conduct in pharmaceutical research. This commitment not only enhances sponsors/clients' reputation within the industry but also builds trust with regulatory agencies and stakeholders.