Regulatory Affairs

Regulatory Affairs
Product Description

The field of RA encompasses all the work necessary to manage products’ registrations and to receive and maintain marketing authorization.Choose PQE Group’s comprehensive support and broad strategic knowledge to launch products without delays and keep them on different worldwide markets.

PQE Group

  • IT
  • 2016
    On CPhI since
  • 1
    Certificates
  • 1000 - 4999
    Employees
Consultancy

PQE Group

  • IT
  • 2016
    On CPhI since
  • 1
    Certificates
  • 1000 - 4999
    Employees
Consultancy

More Products from PQE Group

  • Audits

    Product Audits

    Due to recent regulatory developments concerning raw materials, suppliers, manufacturing and distribution, auditing has become a task of critical importance for Life Science businesses.PQE Group supports Pharma and MD companies in performing many types of certified audits, from routine monitoring to due diligence purposes.
  • Data Integrity Assurance

    Product Data Integrity Assurance

    Data is a fundamental part of any Life Science production cycle and has become a major concern for global regulatory authorities.Choose PQE and ensure patient safety and business continuity within the entire product life cycle.
  • Digital Governance

    Product Digital Governance

    With new advanced technologies and new standards for Compliance and Cybersecurity, developing an intelligent network and infrastructure is a top level priority for Life Science businesses. Choose PQE Group’s all-in-one integrated solutions to coordinate your Corporate Digital Development.
  • Qualification & Engineering

    Product Qualification & Engineering

    The act of Validation, originally addressed only to sterilized equipment, now involves all product, process and facility matters.Choose PQE's solutions to ensure that your plant site meets your business objectives while being fully compliant with the latest Good Manufacturing Practice regulations and standards
  • Quality Compliance

    Product Quality Compliance

    For Life Science businesses in highly regulated environments, compliance is not an option. Prepare to successfully pass inspections and design post-inspections remediation plans to achieve and maintain approval for your product with PQE Group's tailored and cost-effective programs for Quality Management.
  • Laboratory Excellence

    Product Laboratory Excellence

    We provide the expertise and counseling you need to secure the best lab performances and avoid recalls and non-compliances.Don’t risk losing quality and trust: choose the right training, guidance and support.
  • Technology Transfer

    Product Technology Transfer

    As we endure the echoes of the Covid-19 pandemic and, vaccine manufacturing companies face the need to expand the production to meet the highest rates of request in different parts of the world. To do so each company must rely on contract manufacturers to complete the production cycle. PQE can support this knowledge and tool transfer and protect your product, user and business.
  • Advanced Remote Technologies

    Product Advanced Remote Technologies

    Our industry is rapidly evolving to cope with the challenges posed by new markets and the recent COVID-19 global pandemic that has systematically changed our working habits.Choosing PQE Group as your partner, you can perform audits, assessments, validation tests and training safely and remotely.

PQE Group resources

  • News PQE leads the Smart Pharmaceutical Manufacturing coalition (SPuMoNI)

    A programme for European Coordinated Research on Long-term Information and Communication Technologies (ICT) and ICT-based scientific challenges, CHIST-ERA annually calls for research proposals on key emerging topics. In 2017, the brief was ‘Big Data and process modelling for smart industry’.
  • Brochure Brochure PQE 2021

    PQE Group new services brochure 
  • News Danilo Neri Vice President and Partner of PQE Group is now part of the ISPE Italy Affiliate Board delegated for International Relationship

    Danilo Neri, Vice President Operations for PQE Group, has been nominated Member of ISPE Italy Affiliate Board delegated for International Relationship. ISPE (International Society for Pharmaceutical Engineering) is the largest non-profit association in the world dedicated to pharmaceuticals, and, with over 18,000 members and an operation in 90 countries, it deals with networking, solutions’ development and training on new regulations. 
  • Video PQE Group: Global Quality Solutions

    Meet PQE Group, a complete quality solutions provider for Life Science industry. A worldwide coverage, with local solutions in your language.
  • News Gilda D’Incerti, Founder and CEO of PQE Group accepted into Forbes Business Council

    Florence – Italy, February 23rd — PQE Group, quality services provider for Life Sciences, has been accepted into the Forbes Business Council, the foremost growth and networking organization for successful business owners and leaders worldwide. Gilda D’Incerti was vetted and selected by a review committee based on the depth and diversity of her experience. Criteria for acceptance include a track record of successfully impacting business growth metrics, as well as personal a...
  • News Claudio Puglisi, COO of PQE Group, chosen for PDA Executive Committee

    PDA Italy Chapter has chosen the new Chief Operating Officer of PQE Group, Claudio Puglisi, as a member of the executive committee for the role of Chapter Liaison and External Relationship.
  • News PQE and SID&GP, together for Data Integrity guidance

    PQE Group is proud to announce that the draft of the new Russian Guide for Industrial Data Integrity has been published on the website of GILS - Russian State Institute of Drugs and Good Practices.After the collaboration with COFEPRIS, the Mexican Regulatory Authority, for the creation of the data integrity chapter of the NOM 059 (the GMP Rule in Mexico) PQE Group is now supporting GILS and THE MINISTRY OF INDUSTRY AND TRADE OF THE RUSSIAN FEDERATION in setting all the GMP Data Integrity Requirements. PQE Group CEO Gilda D’Incerti will be present in the Kazan 3rd Russian GMP Conference from 27th to 29th of August where the new Guidance will be presented to all local industry and all interested stakeholders. Click here for the event accreditation.TOPIC:The globalization of the supply chain of pharmaceutical products leads to a steady increase in the complexity of the process, when a product can pass through several intermediaries before it can reach a patient. Such an environment implies the probability of penetration into the supply chain of counterfeit, falsified, substandard or improperly manufactured medicines, as forgers constantly improve the process of manufacturing counterfeit products that look identical to the original; most counterfeit drugs have little or no therapeutic value, and can cause serious health problems, since active substances in counterfeits are often absent, their dosage is reduced, their content is distorted or extended beyond the expiry date.To minimize the risks associated with such problems, many state regulatory and control bodies have established specific rules aimed at ensuring the authenticity of pharmaceutical products and, in most cases, tracking drug products throughout the chain of sales. In general, these rules provide for the duty of the owner of the registration certificate to introduce a set of computer systems for the registration, authentication, preservation and exchange of reliable reporting on commercial products before it is released to the market.

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