Immagine centrata

Key Figures

A complete set of local services for Life Science companies that we can scale globally

PLG Italy Services

BIOPHARMA DEVELOPMENT

  • CMC Development
  • Regulatory Consulting
  • QA Consulting (including QP Release Services)

MARKET ACCESS

  • Market Access Strategy
  • P&R and HTA strategy & support
  • HEOR
  • Patient Access & RWD/RWE
  • Research & Intelligence
  • Patient Programs

REGULATORY AFFAIRS & OPERATIONS

  • Non-clinical Development
  • Clinical Development
  • Regulatory Strategy Services
  • Regulatory Writing
  • Regulatory Operations
  • Regulatory Lifecycle Services
  • Regulatory CMC
  • Marketing Authorization Services

SAFETY & VIGILANCES

  • Medical Information
  • Local literature monitoring
  • End to End Safety & Vigilances
  • GSO
  • Safety Writing & Literature Monitoring
  • Case Management

QUALITY & MANUFACTURING

  • Pre-Market Quality Services
  • Market Authorization Holder and Local Affiliate Services
  • Manufacturing Services
  • Audit & Training
  • Non GxP Compliance Management
  • Engineering
  • Qualification & Calibration
  • Facility management-Energy & Waste
  • Digital & Quality Compliance

MEDICAL DEVICES & SELFCARE

  • Medical Devices
  • Nutrition
  • Cosmetic & Dermatological Solutions

CONSULTING & DIGITAL

  • Strategy Consulting
  • Consulting in Operations
  • Digital Consulting
  • Digital Delivery
  • Digital Operations
  • Digital Quality & Compliance

C&P Engineering

C&P Engineering Logo

C&P Engineering is a multidisciplinary engineering and consulting firm specializing in providing tailored solutions for the pharmaceutical, medical, nutraceutical, and cosmetics industries. Founded in 2005, the company supports clients in optimizing industrial processes while adhering to regulatory compliance standards like EU and FDA cGMPs.

Pharma & Process Engineering
Design and implementation of process systems tailored to pharmaceutical and biotech facilities, ensuring regulatory compliance and operational efficiency. This includes facility layout, process flow optimization, and project feasibility studies.
Construction
End-to-end project management of construction activities, from initial planning and permitting to construction oversight and delivery of fully operational facilities such as cleanrooms, laboratories, and production plants.
Qualification, CSV, and DQ&I
Comprehensive validation services, including equipment qualification, computerized system validation (CSV), and documentation for design qualification and installation processes.
Energy, Waste, & Maintenance
Sustainable management solutions for optimizing energy use, reducing waste, and implementing maintenance strategies to improve overall operational efficiency and sustainability.

These services collectively ensure that clients receive a tailored, client-centric approach ensuring cost-effective, high-quality, and compliant solutions across engineering and operational domains.


www.cep-eng.it

C&P Engineering is certified ISO 9001: Certification

Intexo

Intexo specializes in regulatory affairs and patient access within the healthcare sector, combining technical expertise with a strong commitment to societal values:

Market and Patient Access

Development of negotiation strategies, pricing and reimbursement dossiers, and innovative communication projects designed to support product launch and accessibility.

Regulatory Strategy Consulting and Affairs

Combination of strategic consulting and regulatory affairs to help healthcare companies navigate complex regulatory frameworks. Design of forward-thinking strategies to manage shifting compliance standards, optimize market-entry processes, and align operations with long-term regulatory goals.

Commitment to Ethics and Sustainability

As a certified B-Corp, Intexo integrates compliance with quality assurance systems, promotes gender equality, and upholds environmental and social responsibility throughout its operations.

Intexo’s combined technical and ethical framework supports healthcare companies in achieving regulatory milestones while advancing the shared goal of accessible and sustainable healthcare solutions​. They emphasize collaboration with clinicians, patient associations, and scientific communities, while advocating for compliance, quality systems, and gender equality in their operations​.

www.intexo.it

Intexo is certified:

Ecovadis Gold Medal
Bureau Veritas ISO 9001
Rating di legalità

LifeBee

LifeBee is a Consulting and Digital boutique firm, supporting Life Science companies on their path towards Digitalization, Operational Excellence, and Compliance with Customized Advisory and innovative Digital Solutions. The focus is on GxP regulated areas such as Laboratories, Logistics, Manufacturing, Serialization, Pharmacovigilance, Quality Assurance, Regulatory Affairs, Project & Portfolio Management of Biopharmaceutical Companies, Medical Devices, and Nutraceuticals.

Consulting
LifeBee focuses on creating comprehensive strategies for digital transformation, ensuring compliance and data integrity, and promoting operational excellence. The consulting services also involve layout reviews, GxP risk analysis, contamination control strategies, and preparation of detailed digital roadmaps for project execution.

Digitalization
Assists with program and quality management, driving cultural change within organizations. Optimization of procedures, support data migration, improve workflows, and offer of project management services to deliver quick wins in digital transition.

Digital solutions
Provide of market-leading tools for various operational and regulatory needs, including quality assurance, lab management, electronic logbooks, and document management. Specialized in industrial solutions, such as automation integration, serialization, electronic batch recording, and warehouse management.

LifeBee delivers a complete suite of consulting and digitalization services that optimize life science companies’ operations, ensuring compliance while driving transformation. Their tailored solutions allow businesses to streamline processes, reduce risks, and stay competitive by leveraging both strategic advice and innovative digital tools across every phase of product development.


www.lifebee.com

LifeBee is certified:

PEC – Pharma Education Center

Pharma Education Center (PEC) serves as a vital resource for training and professional development within the pharmaceutical, biotech, and life sciences industries. Its offerings are strategically designed to meet the evolving needs of these highly regulated and competitive sectors:
  • Diverse Training Modalities: PEC’s educational portfolio includes on-demand, scheduled, and in-house training sessions. These are customized to cover essential topics such as compliance with international standards (e.g., GMP, ISO), risk management, and the implementation of cutting-edge pharmaceutical technologies.
  • Knowledge-Sharing Events: The center organizes industry-focused events featuring thought leaders who share the latest developments in science, technology, and regulations. These events provide networking opportunities and foster collaboration among professionals.
  • Expert-Led Programs: Courses are designed and conducted by industry experts with extensive field experience, ensuring that participants gain practical insights in addition to theoretical knowledge.
  • Benefits to Organizations: PEC helps companies enhance workforce competence, align operations with regulatory requirements, and build internal capabilities to remain competitive in a globalized market.

Pharma Education Center stands out by delivering flexible, up-to-date, and customized learning opportunities that empower professionals to address industry challenges effectively while contributing to their organizations’ growth.


www.pharmaeducationcenter.it

Pharma D&S

Pharma D&S is a comprehensive consulting firm specializing in the pharmaceutical, biotech, and medical device industries. It provides tailored solutions to support clients throughout the entire product lifecycle, from research and development to post-marketing activities. Its key services include:

Regulatory Affairs
Assistance with strategic planning, dossier preparation, and market authorizations to navigate complex regulatory landscapes for a variety of products, including innovative, generic, herbal, and biological formulations​.

Pharmaco Vigilance
Custom strategies for managing safety data, risk management plans, and compliance with global regulations to ensure product safety during both clinical trials and post-approval phases​.

Quality and Process
Expertise in quality management systems, audits, validations, and compliance strategies designed to enhance operational efficiency and meet stringent industry standards​.

Market Access
Development of strategies focused on market access, including the preparation of pricing and reimbursement dossiers and creation of communication plans to facilitate product launches.

Pharma D&S offers a distinctive value proposition through its highly customizable approach, acting as an extension of client teams, and delivering compliance-focused, efficient solutions tailored to specific needs. Its broad expertise ensures comprehensive support in achieving both regulatory and operational goals.


www.pharmades.it

Pharma D&S is certified:



CONTACT US

By email: [email protected]

 

ProductLife Group
Corso Italia, 17 – 20122 Milan
 
PLG Italy, LifeBee, Intexo
Piazza Luigi di Savoia 22 – 20124 Milan
 
C&P Engineering
Via dei Pratoni, 16 – 50018 Scandicci (FI)
Regus, Piazza Carlo Magno, via Tiburtina 21 – 00162 Rome
Via Roma, 25 -41037 Mirandola (MO)
Centro Direzionale Colombirolo Via Roma 74 – 20060 Cassina de Pecchi (MI)
Talent Garden Genova, Giardini Baltimora – 16121 Genova
Via Funicolare, 4 – 6912 Pazzallo (Lugano) Switzerland
 
PEC – Pharma Education Center s.r.l.
Via dei Pratoni, 16 – 50018 Scandicci (FI)
 
Pharma D&S
Via dei Pratoni, 16 – 50018 Scandicci (FI)
Centro Direzionale Colombirolo Via Roma 74 – 20060 Cassina de Pecchi (MI)
Via Gualtiero Serafino, 8b – 00136 Rome
Centro Direzionale Isola E7, E5 – 80143 Naples