Biotechnology & Life Science

The Biotechnological and Pharmaceutical industries are quickly growing while simultaneously facing increased standardization. Areas such as quality, safety, reliability and performance are more and more unified in the biotechnology and life science sectors. These requirements, set by the ANSM, the EMEA and the FDA, have caused additional stress for companies in this sector. As they suggest a unique advantage, consultancy services are offering professional expertise and strategic support during our client’s adaptations to technological advancements.

RealDev is familiar with the increased expectations in biotechnology and life science, and is also fully prepared to assist any type of project in this sector. Our research and design administers products and solutions to address the issues companies face in this sector. We offer a solution from concept development to installation to ensure the best service possible.

By analysing our client’s needs, our team uses the most advanced technological systems while protecting data integrity and business continuity. In return, we will boost the success of your business by meeting regulations and requirements and surpassing expectations. So, choose RealDev to give your business a real development!

Our Key Competencies

Design

  • Infrastructure

  • Specifications

  • HDS / SDS – Digital Transformation: “Fully harness the power of your data with Hitachi Content Intelligence. Connect to all of your data and break down silos. Analyse, transform and enrich data to ensure maximum data quality.”

Deployment

  • DCS – Distributed Control System

  • PLC – Programmable Logic Controller

  • IT Gateways – Telecommunications

  • MES - Manufacturing execution systems: Track and document the transformation of raw materials to finished goods

Commissioning & Qualification

  • Validation Strategies

  • Validation Matrix setup & follow-up

  • Protocol execution / review

Validation & Quality Assurance

  • GMP reviews

  • Risk analysis

  • Computer System Validation (GAMP5, CFR21 Part 11)

  • Writing and execution of qualifications protocols (GMP, ASTM2500)

  • Integrated commissioning and validation assistance

  • PQ assistance