Prime Life Sciences arises from our desire to make a difference and our commitment to finding the best solutions in different areas.

01.

Our commitment to finding the best solutions to accompany a sector that is constantly evolving proves that Prime LS has a real talent machine.

We are Prime Life Sciences

Our professional goal is to empower companies by using the best talent to keep up with the continuous evolution of the pharmaceutical, biotechnology and medical device industries and by finding the best solutions for each specific need. To achieve these goals, we provide the highest quality services that follow the entire lifecycle of services and products. With a simple and transparent approach, our solid experience enables us to adapt to the real needs of each client, managing consultants specialised in the Life Sciences Industry and guaranteeing the confidentiality of the services we provide.

Why Prime Life Sciences?

  • 01

    We are a Group with more than 18 years of experience in multiple Engineering fields.

  • 02

    We have top-notch professionals whose talent and commitment go hand in hand.

  • 03

    We provide highly efficient services, with the required quality, within the deadlines and budgets established jointly with our clients.

  • 04

    The close relationship we have with our clients and consultants allows us to ensure the best possible results.

  • 05

    We believe that the enthusiasm that drives us leads us to overcome every challenge that comes our way. The satisfaction of hundreds of clients is a reflection of this.

  • 06

    We look to the future with the confidence that people and technology are the right resources for a world without limits when it comes to innovation and success.

Our Values

  • Trust

  • Vision

  • Innovation

  • Excellence

Expertise

We are facing challenging times in the Life Sciences industry, which has been developing in an environment of increasing technological innovation and intense regulation.

To keep up with these demands, a precise strategic vision, efficient performance and a commitment to quality are mandatory requirements to ensure a balanced response to the new market needs.

Only in this way will Life Sciences companies be able to explore the present and future potential of a sector that promises to change the world.

02.

Prime Life Sciences was created to support our clients through a specific range of services:

Pharmaceutical

01

Pharmaceutical

Technical Services

Equipment Qualification and Process Validation

Development

  • Formulation
  • Scale up and Transfer
  • CMO’s management

Engineering: From Concept to Detailed Design

  • Process: calculation, sizing, equipment tendering and selection
  • HVAC and Utilities (Black and White): calculation, sizing, equipment tendering and selection
  • Mechanical Engineering
  • System and Electrical Engineering:
    • Instrumentation
    • PLC
    • SCADA and HMI
    • MES

Equipment Qualification and Process Validation

  • Risk Analysis
  • DQ/IQ/OQ/PQ
  • Qualification Protocols execution and reports review
  • Process Validation
  • Cleaning Validation (CIP/SIP/COP)
  • Computer System Validation

Quality & Regulation

Equipment Qualification and Process Validation

Quality Management System

  • GxP
  • ICH

Quality Assurance

  • Operational QA: CAPA, deviation, change control, batch record reviews, investigations…
  • External Supplier QA’s management
  • Compliance

Quality Control

  • Development and Validation of Analytical Methods
  • Stability studies
  • Analytical Lab Management and lab equipment qualification

Regulatory Affairs

  • CTD and eCTD writing (Modules 3, 4, 5)
  • Submission and Interfacing with Health Authorities (FDA, EMA,…)
  • Maintenance and variation management
  • Pharmacovigilance

Project Management

Equipment Qualification and Process Validation

Clinical Operations

 

Tech Transfer and CMO Management

 

Green and Brown Field, Revamping Projects

  • Project Management
  • Project Control
  • Capex Investment and Procurement
  • HSE

On Field

  • Supervision, Commissioning and Troubleshooting

Audit Readiness

Biotech

02

Biotech

Technical Services

Equipment Qualification and Process Validation

Development

  • Formulation
  • Scale up and Transfer
  • CMO’s management

Engineering: From Concept to Detailed Design

  • USP and DSP Processes: calculation, sizing, equipment tendering and selection
  • HVAC and Utilities (Black and White): calculation, sizing, equipment tendering and selection
  • Mechanical Engineering
  • System and Electrical Engineering:
    • Instrumentation
    • PLC
    • SCADA and HMI
    • MES

Equipment Qualification and Process Validation

  • Risk Analysis
  • DQ/IQ/OQ/PQ
  • Qualification Protocols execution and reports review
  • Process Validation
  • Cleaning Validation (CIP/SIP/COP)
  • Computer System Validation

Quality & Regulation

Equipment Qualification and Process Validation

Quality Management System

  • GxP
  • ICH

 

Quality Assurance

  • Operational QA: CAPA, deviation, change control, batch record reviews, investigations…
  • External Supplier QA
  • Compliance

Quality Control

  • Development and Validation of Analytical Methods
  • Stability studies
  • Analytical Lab Management and lab equipment qualification

Regulatory Affairs

  • CTD and eCTD writing (Modules 3, 4, 5)
  • Submission and Interfacing with Health Authorities (FDA, EMA,…)
  • Maintenance and variation management

 

Pharmacovigilance

 

Project Management

Equipment Qualification and Process Validation

Clinical Operations

 

Tech Transfer and CMO’s Management

 

Green and Brown Field, Revamping Projects

  • Project Management
  • Project Control
  • Capex Investment and Procurement
  • HSE

 

On Field

  • Supervision, Commissioning and Troubleshooting

 

Audit Readiness

Medical Devices

03

Medical Devices

Technical Services

Equipment Qualification and Process Validation

Products Development: Medical Devices Class I, II, III (Combined Products, Diagnostic Tools, Implants)

  • Mechanical and system engineering
  • Hardware and software engineering
  • Design Control and History File (CFR 21 820 and ISO13485)
  • Risk management (ISO 14971)
  • Human factors engineering (ISO 62366)
  • Verification & Validation
  • Packaging Development

Process Development: From Concept to Detailed Engineering

  • Process: calculation, sizing, equipment tendering and selection
  • HVAC and Utilities (Black and White): calculation, sizing, equipment tendering and selection
  • Mechanical engineering
  • System and Electrical Engineering:
    • Instrumentation
    • PLC
    • SCADA and HMI
    • MES

Qualification and Validation

  • Risk Analysis
  • DQ/IQ/OQ/PQ
  • Protocol execution and reports review
  • Process Validation
  • Cleaning Validation (CIP/SIP/COP)
  • Computer System Validation

Quality & Regulation

Equipment Qualification and Process Validation

Quality Management System: ISO 13485, ISO 14971, ISO 62366, 21 CFR Part 820…

Quality Assurance

  • Operational QA: CAPA, deviation, change control, batch record reviews, investigations…
  • External Supplier QA
  • Compliance

Quality Control

  • Medical Devices Testing
  • Development and Validation of Analytical Methods
  • Stability studies and Biocompatibility
  • Analytical Lab Management and equipment qualification

Regulatory Affairs

  • CE marking, 510(k)
  • MDR, IVDR compliance

Post-market Monitoring

Project Management

Equipment Qualification and Process Validation

Clinical Operations

Tech Transfer and CMO’s Management

Green and Brown Field, Revamping Projects

  • Project Management
  • Project Control
  • Capex Investment and Outsourcing
  • HSE

On Field

  • Supervision, Commissioning and Troubleshooting

Audit Readiness

03.

A Prime Group Company

Thanks to the dedication and professionalism of our teams, our company has successfully transformed the lives of thousands of people over the years.

Prime Group is guided by a clear vision of the future, with a distinct passion for innovation. Prime Life Sciences, Always One Step Ahead.

Prime Group Website

Prime Group is an international group with over 18 years of experience in Engineering, Innovation and Digital Transformation.

Prime Group

  • +3k

    Qualified Professionals

  • +58

    Nationalities

  • 31

    Offices in Europe

  • 14

    Companies

Careers

Let’s change the world together.

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04.