Prime Life Sciences arises from the desire of experienced professionals from Prime Group to make a difference, with the commitment to find the best solutions in different fields.

01.

Our commitment to find the best solutions to accompany a sector in continuous evolution, confirms that today Prime LS has a real machine of talent.

We are Prime Life Sciences

Our professional goal is to empower companies using the best talent to keep up with the continuous evolution of the pharmaceutical, biotechnology and medical device industries, finding the best solutions for each specific need. To reach 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 each client's real needs, managing consultants specialised in the Life Sciences Industry, guaranteeing the confidentiality of the services we provide.

Why Prime Life Sciences?

  • 01

    We are a Group with more than 14 years of experience in multiple Engineering fields.

  • 02

    We have highly qualified professionals, and their talent and commitment stand side by side.

  • 03

    We provide highly efficient services, meeting the required quality, at the right timings and meeting the budgets stipulated by our customers, always reaching the goals that we have set ourselves together.

  • 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 we are faced with, and the satisfaction of hundreds of clients is a reflection of this.

  • 06

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

Our Values

  • Trust

  • Vision

  • Innovation

  • Excellence

Expertise

We are facing challenging times in the Life Sciences industry, which is developing in an environment of intense regulation and growing innovation in technology.

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

This will allow Life Sciences companies to explore all the potential, present and future, of this sector that promises to change the world.

02.

Prime Life Sciences has been created to support our costumers within this context within a specific service offer:

Pharmaceutical

01

Pharmaceutical

Technical Services

Equipements 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’s Qualification and Process Validation:

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

Quality & Regulatory

Equipements 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’s qualification

Regulatory Affairs:

  • CTD and eCTD writing (Module 3,4,5)
  • Submission and Interfacing with Health Authorities (FDA, EMA,…)
  • Maintenance and variations Management
  • Pharmacovigilance

Project Management

Equipements 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

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

Quality & Regulatory

Equipements 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 (Module 3,4,5)
  • Submission and Interfacing with Health Authorities (FDA, EMA,…)
  • Maintenance and variation Management

 

Pharmacovigilance

 

Project Management

Equipements 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

Equipements Qualification and Process Validation:

Products Development: Medical Devices Class I,II,III (Combined products, Diagnostics 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 Elect engineering:
    • Instrumentation
    • PLC
    • SCADA and HMI
    • MES

Qualification and Validation:

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

Quality & Regulatory

Equipements 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 Biocompatibilities
  • Analytical Lab Management and equipment qualification

Regulatory Affairs:

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

Post market Monitoring

Project Management

Equipements 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

Our company has successfully transformed the lives of thousands of people over the years through its growth, which is the result of the dedication and professionalism of all members of our teams, reflecting the confidence they have acquired in this highly competitive market.

Prime Group is guided by a clear vision towards 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 14 years of experience focusing on Engineering, Innovation and Digital Transformation.

Prime Group

  • +2k

    Qualified Professionals

  • +50

    Nationalities from 5 Continents

  • 20

    Offices Around the Europe

  • 08

    Companies

Careers

Let’s change the world together.

Find out how Prime Life Sciences can be the next step in your career.

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04.