NEMERA’s Post

Your #regulatory strategy defines the road to market authorization. But there are many common mistakes that #drug developers can make, losing time and money. Erika Spens shares her expert insight on shaping a comprehensive regulatory strategy, how to make use of the opportunities and how to mitigate the risks. https://bit.ly/4adfCYp #biotech #pharma #pharmaceutical #pharmaceuticalindustry #regulatoryaffairs #FDA #EMA #clinicaldevelopment #drugdevelopment #clinicaltrials

Your #regulatory strategy defines the road to market authorization. But there are many common mistakes that #drug developers can make, losing time and money. Erika Spens, Director of Regulatory Affairs, shares her expert insight on shaping a comprehensive regulatory strategy, how to make use of the opportunities and how to mitigate the risks. https://bit.ly/3SZOBSK #biotech #pharma #pharmaceutical #pharmaceuticalindustry #regulatoryaffairs #FDA #EMA #clinicaldevelopment #drugdevelopment #clinicaltrials

Exciting news for the clinical research community in India! The Central Drugs Standard Control Organisation (CDSCO) has issued draft guidelines to strengthen protocols for clinical trials, aiming to maintain product quality and expedite trials for novel medications and vaccines. Key takeaways: - Pharmaceutical companies must report premature termination or adverse events within set timeframes - More detailed information on tests is required - Applications must be submitted before starting a trial in India - Status reports are required at prescribed periods - Summary of trial results, including reasons for premature termination, must be submitted within 3 months in a paperless format - Major adverse events must be reported within 14 days These guidelines aim to bring transparency and reduce clearance time for clinical trials. What are your thoughts on this development? Share your insights! #clinicaltrials #CDSCO #India #pharmaceuticals #regulatoryaffairs #clinicalresearch #transparency #efficiency

Rigorous analytical testing is one of the key aspects of pharmaceutical quality assurance. It begins with the earliest stage of drug development when molecules show therapeutic promise. Labs meticulously test these molecules to ensure their safety, identity, strength, and efficacy. This dedication to quality extends throughout the entire drug life cycle, from discovery to clinical trials to mass production. https://lnkd.in/eaSyFHs4

Ever wondered how the medicines you buy over the counter reach you? The journey from drug conception to pharmacy shelf is a complex and multifaceted process. It begins with research and development, where new molecules are discovered or existing ones are repurposed to address unmet medical needs. Preclinical testing is crucial in determining if a compound warrants further development. This is followed by clinical trials, involving rigorous testing in human subjects to assess safety, efficacy, and optimal dosage. After regulatory approval, pharmaceuticals enter the manufacturing phase, characterized by meticulous attention, stringent quality control, and advanced technology to ensure safe and effective drug production. The manufacturing phase includes raw material sourcing, formulation and process development, manufacturing operations, and quality control. Adherence to Good Manufacturing Practices (GMP) is central to the pharmaceutical value chain, with organizations like the WHO and the European Union establishing GMP standards to harmonize quality worldwide. The FDA review team meticulously examines the contents, and if deemed complete, the team has 6 to 10 months to decide on approval. #RND #drug #pharmacy #medicineshelf #pharma #pharmainnovation Priyank Vaghashia Bhanu Vaghashia https://lnkd.in/dg-Qj_rS

Explore the critical role of post-market surveillance and compliance in the pharmaceutical industry. Read our latest blog to learn more. https://lnkd.in/gC4fWaSM #Pharma #DrugSafety #Compliance #PostmarketSurveillance #FreyrSolutions

Explore the critical role of post-market surveillance and compliance in the pharmaceutical industry. Read our latest blog to learn more. https://lnkd.in/gC4fWaSM #Pharma #DrugSafety #Compliance #PostmarketSurveillance #FreyrSolutions

Sharing a great reference for colleagues working on medical devices and combination products. FDA Draft Guidance on Essential Drug Delivery Outputs for Devices Intended to Deliver Drugs and Biological Products. #fda #pharmaceutical #medicaldevices #combinationproduct #patientsafety https://lnkd.in/gm2EBBpc

❄ LATITUDE Pharmaceuticals now offers GMP lyophilization services! ❄ At LATITUDE Pharmaceuticals, we now offer top-tier GMP lyophilization services designed to meet the rigorous demands of Phase1 and Phase2 clinical trial materials. With years of experience in developing complex lyophilized drug formulations, LATITUDE now ensures high-quality manufactured freeze-dried drug products that maintain their integrity and stability. Why choose LATITUDE for GMP manufacture of your lyophilized drug product? 🔬 Expertise in freeze-drying biologics, small molecules, and sensitive formulations 🔬 Customizable batch sizes tailored to early-phase clinical trials 🔬 Adherence to strict regulatory guidelines for cGMP compliance 🔬 Fast turnaround times and flexible project management Let’s connect and explore how LATITUDE can support your clinical development! This is just one of the many updates we’re implementing to enhance our capabilities and better serve your drug development needs. Stay tuned for more exciting announcements or visit https://lnkd.in/gYKG9eV7 to review them all! #Lyophilization #GMPClinicalSupplies #Pharmaceuticals #Biopharmaceuticals #Phase1 #Phase2 #DrugDevelopment #LATITUDEPharma #CRDMO #Flexible #RapidResponse #Innovation