Stephen Gannon’s Post

Too Many Cooks Spoil the Broth..... When managing the complex processes of pharmaceutical production, involving multiple partners can often lead to inefficiencies, increased costs, and challenges in maintaining communication. At Surepharm Services Ltd, we are a cost-effective UK-based CDMO with over 30 years of expertise in oral dose human and veterinary medicines. Our full licenses from the VMD and MHRA, combined with our GMP accreditation, enables us to offer an end-to-end solution for manufacturing, assembly/packing, and testing/release of product to market —all under one roof. If you hope to streamline operations, get to market quicker, reduce cost or increase consistent quality in 2025, pop us a message and lets chat. #Pharma #Biotech #Human #Animal #Oralsoliddose #Manufacturing #Production #assembly #packing #testing #release #VMD #HMRA #GMP

EMA published a document titled "Questions and answers regarding co-processed excipients used in solid oral dosage forms (H & V)" on 11 September 2024 for public consultation. It specifies the quality requirements for CoPEs used in solid oral dosage forms in both human and veterinary pharmaceuticals. The use of CoPEs in pharmaceutical formulations is thought to pose high risk than utilizing individual excipients. The risk arises from reasons such as composition complexity, quality control, formulation development, and stability difficulties. The Q&A attempts to use a risk-based approach to standardize and clarify CoPE dossier criteria. It defines three risk categories for the CoPE: high, medium, and low, as well as the risk factors that the MAH/applicant should consider when determining the appropriate risk category, and the related quality dossier requirements that must be provided by the MAH/applicants as part of new MAAs or variations. #EMA #CHMP #CVMP #CoPE #CoPEs #coprocessed #excipient #MAA #variation

“Discipline, good internal collaboration, and a focus on partnership with our customers are key to our stability programme’s success,” said Lisa Bergerud, Stability Coordinator at Argenta in Fort Dodge, USA. Stability studies are essential to the development process and to ensure that veterinary pharmaceutical products maintain their quality, safety, and efficacy throughout their shelf life. Drug stability testing is a complex process involving significant cost, time, and skills to generate data. Have you considered outsourcing stability studies to free up in-house experts and resources? Download the free white paper to learn more about Argenta’s stability programme and the benefits of outsourcing: https://hubs.li/Q02sTrzk0 #CDMO #Argenta #AnimalHealth #VeterinaryPharma #StabilityTesting

Understanding HS Codes 3003 and 3004 is essential for businesses involved in the transport of medicaments. These classifications encompass a wide range of pharmaceutical products, and compliance with regulatory requirements is crucial for ensuring safety and efficacy. With the increasing complexity of shipping regulations, partnering with a trusted logistics provider can streamline the process and enhance compliance. Mercury is committed to providing expertise in the logistics of medicaments, ensuring that all shipments meet the necessary health and safety standards. Mercury partners with Sensitech to provide clients with precise monitoring capabilities for ensuring the safety of their goods. For more insights on the regulatory landscape surrounding HS Codes 3003 and 3004, click the link to read the full article on the Mercury website. https://lnkd.in/dfTWjJAR #Mercury #Logistics #Partner #Healthcare #LifeSciences #HS #HS3003 #HS3004 #Codes #Medicaments

The HPRA has completed its public consultation on proposed fees for 2025, covering human medicine, medical devices, compliance, and veterinary medicine. What this means for our Irish customers using APIs: For those sourcing active pharmaceutical ingredients (APIs) in Ireland, here’s how these changes could affect you: 🔸 Potential cost increases: Suppliers may face higher regulatory fees, which could lead to slight cost increases across the API supply chain, potentially affecting manufacturers and, downstream, consumers. 🔸 Maintained safety standards: The HPRA’s fee adjustments ensure rigorous oversight, safeguarding the high safety and quality standards that protect end-users. 🔸 Market stability: By freezing fees for dormant authorisations, the HPRA supports smaller or less frequently used API suppliers, preserving market diversity and competition. Overall Impact: While some cost adjustments might occur, these changes aim to sustain effective industry regulation and uphold critical safety benchmarks. Let us know if you’d like further insights on how this might influence your operations. #HPRA #IrishPharmaceuticalIndustry #APIUsers #SafetyStandards #RegulatoryUpdates

Need to secure CITES or veterinary certificates for your pharmaceutical products? Look no further! Frontro Pharma provides expert assistance in obtaining these crucial certifications. Our team ensures a smooth process, so you can focus on your business. Contact us today to streamline your certification needs! visit now: https://frontropharma.com/ #Pharmaceuticals #CITES #VeterinaryCertificates #PharmaSolutions #FrontroPharma #ExpertAssistance #PharmaCertification #VeterinaryPharma #Compliance #RegulatoryServices #PharmaSupport #StreamlineCertification #ContactUsToday #PharmaExperts #BusinessSupport

CDSCO had issued notification that In order to streamline the regulatory submission procedure, the submission of applications of PSURS (Period Safety Update Reports) w.r.t Marketing Authorization of New Drugs/ Subsequent NewDrugs (SND/ Fixed Dose Combinations (FDC)/ Biologicals/ Veterinary is functional now through online system of Sugam portal at www.cdscoonline.gov.in. All applicants submitting PSURs shall apply through online portal as per checklist in the Portal The facility of offline submission of applications in hard copy or any other mode will not be available for processing from 11.03.2024. #regulatoryaffairs #newdrugs #marketingagency #marketingAuthorisation #pharmaceutical #india #notification #psur #Sugam

Discover how the Cloudbyz Vet eClinical Platform meets the latest FDA guidelines! Our integrated systems ensure compliance, streamline study processes, and enhance data quality in veterinary drug development. https://hubs.li/Q02zN0pC0 To learn more book a meeting here: Connect at https://hubs.li/Q02zM_950 #DataCapture #CTMS #eTMF #RTSM #Safety #PV #Pharmaceutical #Biotechnology #MedicalDevices #Diagnostics #Cloudbyz #ClinicalTrials

Why execute any veterinary pharmaceutical product or preparation that does not conform to the specifications, when we have the solution without effort or effort, and we process the product inside your factory and in the same place, without opening the package, and it will be as it is and without any loss. Do not worry and do not be upset, and the result will conform to the specifications. Rather, it is better to try it in a small quantity. For inquiries, call Find us at your service and the product is our product This is according to FDA requirements

How do labeling and coding technologies assist pharmaceutical companies in ensuring drug safety, streamlining supply chain logistics, and enhancing patient care? To gain deeper insights into the evolution and revolution of such technologies, download our whitepaper! https://lnkd.in/gZ5n6ssp #Labeling #Coding #DrugSafety #PatientCare #SupplyChain #RegulatoryCompliance #WhitePaper #FreyrSolutions