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Pharma Tech Outlook: Pharma Tech Magazine

Evnia: A Smart Way to Tackle Regulatory Compliance
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Top 10 Compliance Consulting/Service Companies in Europe - 2020

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The life sciences industry was already undergoing considerable regulatory change prior to the pandemic, and must now expeditiously address new challenges and priorities pertaining to compliance. Organizations must evaluate the ways in which they can utilise their limited resources efficiently with safety precautions amid the new norm. Re-analysing the balance between in-house capabilities and strategic outsourcing relationships could introduce invaluable solutions and other possibilities. Hiring strategic outsourced solution providers can furnish major support for strategically managing the current temporary instability.

The benefits of such measures are multiple:; speeds time to market, reduces the risk of products being taken off the market, and may even help to augment market share where demand is growing.

Digitisation is another key feature in adhering to the latest compliance standards. Some of the common issues such as missing or inconsistent data patters can be removed by simply digitising the records. As multiple production, compliance and business systems come together, there will be an added opportunity to integrate them and manage change proactively leading to better compliance. Integration also presents other advantages like boosting productivity by eliminating wasted efforts in managing multiple systems in isolation.

Pharma Tech Outlook’s editorial board has assessed and shortlisted a number of the foremost prominent organisations within the compliance service industry. We hope this issue of the Pharma Tech Outlook helps you build the partnership you and your firm need to foster a technologically-driven learning environment.

We present to you Pharma Tech Outlook’s “Top 10 Compliance Services Companies in Europe - 2020.”

    Top Compliance Consulting/Service Companies in Europe

  • Evnia is a Denmark-based company that offers expert regulatory, clinical, and technical documentation services to Medical Device and In Vitro diagnostics manufacturers to help them bridge regulatory gaps and ensure patient safety.The core competency of Evnia includes developing and maintaining compliant clinical evaluation reports (CERs), together with supporting documentation for medical devices of all classes to help organisations comply with MEDDEV 2.7.1 REV4 and the upcoming MDR. Further, the company also provides IVDR services that consist of a Performance Evaluation Plan (PEP) and a Performance Evaluation Report (PER), enabling IVD manufacturers to continually demonstrate their scientific validity and enhance analytical and clinical performance of an IVD device, while exposing any potential gaps or risks.

    evnia.dk

  • A pharmacovigilance service provider based in Spain (EU). It provides services to Marketing Authorisation Holders, Sponsors and other pharmacovigilance service providers to help the Pharmaceutical industry to comply with Pharmacovigilance regulatory requirements. Its specialities include Pharmacovigilance services, EU-QPPV and Local contact person for pharmacovigilance in EU countries, Pharmacovigilance Audits, EudraVigilance compliance, and Pharmacovigilance training

    pvpharm.com

  • Diamond Pharma Services

    Diamond Pharma Services

    Diamond Pharma Services is a leading technical services and regulatory affairs consulting group, providing expert support and advice to pharmaceutical and biotechnology companies. Through analysis, interpretation and distillation of data, Diamond Pharma Services helps obtain and maintain medicinal product licences across all stages of a product’s life cycle

  • gempex GmbH

    gempex GmbH

    Provides the required guarantee regarding all compliance matters

  • gmPlan GmbH

    gmPlan GmbH

    Offers services to interested partners in the healthcare and consumer protection on the subjects of quality management, efficacy and safety of regulated products - in particular drugs and their precursors - on

  • LifeBee - Digitalizing Life Sciences - supporting Life Science companies on their path towards digitalization, business excellence and compliance with Digital Advice and Digital Solutions.Our key focus is on GxP regulated areas such as Manufacturing, Quality Assurance, Laboratories, Logistics, Serialization, Project & Portfolio Management, Regulatory Affairs and Pharmacovigilance of Biopharmaceutical Companies, Medical Devices, Nutraceuticals and Cosmetics

    www.lifebee.it

  • PharmaLex GmbH

    PharmaLex GmbH

    A leading provider of specialized services for the pharma, biotech and medtech industries

  • Pharmaplan

    Pharmaplan

    Develops all types of buildings and infrastructures for the pharmaceutical industry and cover the relevant disciplines with our internal specialist teams

  • PharmSol

    PharmSol

    Founded in 2004 as an integrated pharma solutions provider, our experience and operational flexibility allows us to deliver comprehensive, customized and competitive solutions addressing all needs of our clients and partners. Today, PharmSol has direct presence across Europe, Asia and Middle East through eight different PharmSol subsidiaries. With local presence in several geographies, PharmSol offers integrated solutions with ‘single window’ access to all its clients. This ensures seamless and timely deliverance on all assignments

  • ProductLife Group

    ProductLife Group

    Delivering Regulatory, Pharmacovigilance and Quality Assurance services to Life Sciences companies and their global affiliates across the product life cycle through extensive outsourcing expertise and technical service support