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  • STRATEGY

    Smarter Pharma

    Quality management systems QMS are the backbone of pharmaceutical manufacturing ensuring safe products

  • EXPERT Talk

    Compliance to Competitive Advantage in Pharma Supply

    Compliance gets you through an audit Resilience gets medicines to patients on the day something unexpected happens The DSCSAs enhanced requirements took effect November but real interoperability required three more rounds of accommodation phased implementation with the smalldispenser

KNOWLEDGE BANK

  • Articles

    The 2025 Agenda: Navigating New European Compliance Challenges in Pharma

    EU pharma industry expectate new regulations changes in the year European Medicines Agency EMA and other regulatory authorities in the continent gradually increase regulatory requirements that exercise greater pressure on business entities to implement patientoriented sustainable and innovative production standards

    Digital Twins: The Future Blueprint for Pharmaceutical Production

    Digital Twins have revolutionized the pharmaceutical industry by providing virtual replicas of physical assets and processes This innovative technology offers a comprehensive view of manufacturing

    Risk Management in Pharmaceutical Manufacturing

    The pharmaceutical industry operates under strict regulatory oversight because medicines directly affect patient health and safety Manufacturers must consistently produce products that meet predefined standards of quality safety efficacy identity strength and purity Achieving these objectives requires a proactive approach to identifying and controlling risks throughout the product lifecycle

    From Molecule to Market: Building a Regulatory-Ready Manufacturing Strategy

    Every pharmaceutical executive can recite the journey from molecule to market Far fewer can say with confidence at which point in that journey their manufacturing strategy became capable of withstanding a regulatory inspection The distinction matters more than it once did Approval timelines are compressing

    Biopharmaceutical Facility Design for Sustainability: A Comprehensive Overview

    The design and operation of biopharmaceutical facilities play a pivotal role in shaping the environmental impact of the pharmaceutical industry In recent years there has been a growing emphasis on sustainability within this sector

    Virtual Webinars for Pharma Lead Generation: B2B Strategies 2026

    In the changing environment of pharmaceutical marketing digital interactions have acquired the first place Although traditional facetoface conferences and trade show remain important virtual conferences are replacing them and at times complementing them Of them the pharma webinars have proven to be an effective approach to BB lead generation so pharmaceutical companies can connect with the audienc...

TOP ARTICLES

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    Risk Management in Pharmaceutical Manufacturing

    Venkata Reddy Pothireddy

    Risk management is a critical element of pharmaceutical manufacturing that supports product quality, patient safety, regulatory compliance, and business continuity. As manufacturing processes become m...

press releases Read more...

Medicovestor Announces FDA Fast Track Designation for MC001, Its First-in-Class Chemoimmunotherapy ADC for Pancreatic Cancer

Medicovestor Inc today announced that the US Food and Drug Administration FDA has granted Fast Track designation to MC its lead investigational firstinclass chemoimmunotherapy antibodydrugconjugate ADC for pancreatic cancer

Orogen Therapeutics Announces Selection of Two Development Candidates for Immune Diseases, Potential Best-in-Class Oral IL-17 and JAK1/TYK2 Small Molecule Inhibitors

Orogen Therapeutics Inc announced the selection of two development candidates DCs ORO and ORO potential bestinclass oral small molecule inhibitors of IL and JAKTYK respectively Both DCs have completed extensive nonclinical studies to demonstrate attractive

MacroGenics Announces First Patient Dosed in Phase 1 Study of MGC030 in Patients with Advanced Solid Tumors

MacroGenics Inc a clinicalstage biopharmaceutical company focused on developing innovative antibodybased therapeutics for the treatment of cancer today announced that the first patient has been dosed in the Phase study of MGC a firstinclass antibodydrug conjugate

Legend Biotech Announces U.S. FDA Clearance of IND Application for LB2501, an Investigational CD19/CD20 In Vivo CAR-T Therapy

Legend Biotech Corporation a global leader in cell therapy today announced that the US Food and Drug Administration FDA has cleared the investigational new drug IND application for LB an investigational in vivo CART therapy designed to generate CDCD dualtargeting chimeric antigen receptor T

21 - 23

Oct 2026

21 - 22

Oct 2026

22 - 23

Oct 2026

PDA Aseptic Symposium 2026

Congress Square Nakanoshima, O...

26 - 28

Oct 2026

ACHEMA Middle East 2026

RICEC, Riyadh, KSA, Saudi Arab...

26 - 28

Oct 2026

World Orphan Drug Congress

RAI, Amsterdam, Netherlands

27 - 28

Oct 2026

Pharma Manufacturing & Automation Convention 2026

Novotel Hyderabad Airport, Ind...

28 - 30

Oct 2026

02 - 04

Nov 2026

Pharma Forum EMEA 2026

Dom Pedro Lisboa Hotel, Lisbon...

LATEST NEWS Read more...

ScionxBio Announces Collaboration to Develop Long-Acting xRNA Therapeutics

ScionxBio a privately held preclinicalstage biotechnology company pioneering nextgeneration mRNA therapeutics distinguished by their extended durability profile today announced that it has entered into a worldwide strategic collaboration and licensing agreement with Sanofi

Takara Bio USA Partners with SPT Labtech to Deliver Automation-Ready NGS Library Preparation Technologies

Takara Bio USA Inc a wholly owned subsidiary of Takara Bio Inc and SPT Labtech today announced their partnership to deliver validated automated library preparation workflows that combine Takara Bio nextgeneration sequencing NGS library preparation chemistries with SPT Labtechs firefly liquid handlin...

AtomVie Global Radiopharma Announces Strategic Partnership with Jubilant Radiopharma to Strengthen Logistics and Distribution in Clinical Trials

AtomVie Global Radiopharma a global contract developer and manufacturer CDMO for radiopharmaceuticals today announced a strategic partnership with Jubilant DraxImage Inc operating as Jubilant Radiopharma Jubilant Radiopharma to provide logistics approval and lastmile distribution services to support

Transcripta Bio Announces Research Collaboration to Advance Discovery of New ALS Treatments

Transcripta Bio an AIpowered drug discovery company focused on neurological and neuromuscular diseases today announced a research collaboration and licensing agreement with Mayo Clinic centered on amyotrophic lateral sclerosis ALS a fatal neurodegenerative disease with few effective treatments

Insitro Announces a Strategic Collaboration with AstraZeneca for AI-enabled Discovery of Novel Therapeutics for MASH and Cardiomyopathies

Insitro an AI company unlocking causal human biology to systematically generate highvalue therapeutics to treat grievous illness today announced a worldwide exclusive research collaboration agreement with AstraZeneca to discover novel targets and therapeutics in metabolic dysfunctionassociated steat...

Vir Biotechnology Enters Multi-Program Collaboration and License Agreement with Gilead Sciences to Discover and Develop Novel PRO-XTEN® Dual-masked T-cell Engagers for Solid Tumors

Vir Biotechnology Inc announced a collaboration and license agreement with Gilead to discover and engineer three novel PROXTEN dualmasked Tcell engager TCE development candidates targeting selected solid tumorassociated antigens Gilead will have an exclusive license to develop and commercialize