ProductLife Group announces its intention to merge with Pharma D&S Group, expanding its overall offering and Italian footprint

ProductLife Group is making a major move in expanding its services and market presence by merging with Pharma D&S. With this strategic alliance, PLG reinforces its ability to tackle the Italian market on its core services and positions itself as a global leader in the Life Sciences industry. With more than two hundred and fifty employees, Pharma D&S Group is PLG’s largest build-up to date.

Change Management: use of promotional videos in the context of an eDMS implementation project

Discover the power of promotional videos in change management for eDMS implementation projects. Learn how effective communication, addressing human challenges, and leveraging video content can drive the successful adoption of regulatory document management systems. Enhance engagement, educate stakeholders, and ensure compliance with PLG’s expertise in end-to-end video production.

CEP 2.0 Implementation and its impact on quality and layout of CEP

CEP 2.0: Enhancing Transparency and Regulatory Acceptance in Pharmaceutical Certificates of Suitability. Discover the new-look CEP, designed to provide greater transparency without increasing regulatory burden. With an electronic format and digital signature, CEPs become easily shareable as PDFs, streamlining the application process. Implementing CEP 2.0 changes layout, content, and assessment, including using EMA SPOR/OMS Org and Loc IDs. The coexistence of ‘old look,’ ‘hybrid look,’ and ‘new look’ CEPs ensures a smooth transition.

Evaluation of prospective service providers: supervision of the relationship with service providers for pharmacovigilance

Are you looking to enhance your pharmacovigilance program? Choosing the right service provider is crucial for ensuring drug safety and efficacy. Learn about evaluating prospective service providers and effectively supervising the relationship for pharmacovigilance.

Pharma Distribution : A Coming of Age

Over the past few years, the global distribution chain has faced serious trials. Pharma logistics was no different. In the post-COVID era, we are noticing a resurgence in pharma distribution. These improvements can be attributed to specialty pharma and the utilization of CMOs. Learn how “one step back and two steps forward” has impacted pharma logistics in a positive way with a bright future ahead.

Combined Product Development Challenges

Unleash the Potential of Combined Products with PLG: Navigate the complex landscape of drug-device combinations and stay ahead of evolving regulations.
Our dedicated resources offer comprehensive support, from global strategy and compliance to clinical evaluations and life cycle maintenance.

UK National Contact Person for Pharmacovigilance

Are you familiar with the role of the UK National Contact Person (NCP) for Pharmacovigilance? Discover the essential responsibilities of this pivotal position appointed by Marketing Authorization Holders (MAH) to oversee and coordinate pharmacovigilance activities within the United Kingdom and learn about the nomination process, as well as the key role of the NCP in facilitating communication between MAH and the Medicines and Healthcare products Regulatory Agency (MHRA).

The vital role of Graduated Plan Officers in pharmaceutical entrepreneurship

Through the German Medicines Act, Graduated Plan Officers are essential in ensuring the safety and compliance of medicinal products. Their expertise goes beyond that of EU-QPPVs, encompassing tasks like recording complaints and reporting defects to local authorities. With a strong focus on regulatory adherence and pharmacovigilance, Graduated Plan Officers play a critical role in safeguarding public health. Failure to appoint them is a legal violation, carrying potential penalties and investigations.

Insight to Acquiring PL License across the UK from PLGB and PLNI

Gain valuable insights into acquiring “PL” Licenses across the United Kingdom from PLGB (Product License Great Britain) or PLNI (Product License Northern Ireland). Discover the implications of Brexit on Marketing Authorisations and how the MHRA is now responsible for granting Marketing Authorisation in the UK and learn the new procedures and choices for managing your Marketing Authorisations and Applications.

Medical Devices: Guidance for Manufacturers on Vigilance

Discover the crucial role of vigilance in safeguarding the safety and effectiveness of medical devices. Manufacturers must adhere to stringent regulations and implement robust vigilance systems to monitor device performance, identify potential risks, and take prompt corrective actions.This detailed guidance explores the United Kingdom’s regulations, including reporting criteria, timelines, and responsibilities of manufacturers, UK Responsible Persons, and Authorized Representatives.

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June 2023 Monthly Newsletter