Consultancy on pharmaceutical biotech process
The pharmaceutical market is evolving, with reduced reliance on large scale blockbuster drugs and a greater focus on personalised medicine and treatments and therapeutics for less common conditions.
As a result, pharmaceutical manufacturers need to be more flexible and responsive to changing market demands while also remaining commercially viable.
Scitech’s 20-year history of delivering consultancy, design, engineering and construction expertise means that we have the unique capabilities required to support the upgrade, expansion or new build of pharmaceutical biotech processes, laboratories, manufacturing and research facilities, cleanrooms and other complex spaces and systems.
Our multidisciplinary team has extensive experience in the highly regulated pharmaceutical sector, and are able to provide consultancy on the pharmaceutical biotech process. Due to this technical understanding, we can provide innovative solutions to meet our clients’ needs, whether it be to alter or upgrade an existing facility, de-bottleneck and improve manufacturing capacity or develop a new process or facility. We hold specific skills related to:Read more
- handling of potent chemical, dangerous biological and radioactive materials in high containment facilities,
- design and reduced bio-burden environments and the production of sterile materials,
- high hazard materials.
Compliance is critical to safeguard the integrity and safety of the final product. We understand this and have detailed knowledge of the health and safety, regulatory and GxP requirements and guidelines, including WHO, FDA, EMA, MHRA, ICH, ISPE, COSHH, ACDP, SAPO, GMO, DSEAR.
We also understand that business continuity is important, and so we will aim to mitigate potential impact on business operations when working in a live environment within existing operational facilities. We will always plan project delivery to reduce adverse impact, minimise downtime and reinstate operations quickly, ensuring any validation is undertaken to maintain the integrity of existing production.
Our personalised approach to business involves taking the time to understand our clients and their current and future business goals. In considering a client’s business values, drivers and constraints, we ensure that our design and engineering solutions meet expectations and deliver the required results from the outset, reducing risk and saving our clients time, effort, and money.
Through our services, we can offer the pharmaceutical sector many benefits including:
- Multi-disciplinary team. We are unique in that our full design and build capabilities which includes an extensive and experienced CQV team. This means we can deliver the complete scope of a project in-house, from consultancy through to construction, validation and hand over.
- Personalised approach. We offer a personalised approach regardless of project size, collaborating and supporting our clients throughout the duration of the project, whether it is a small change improvement project or a large green-field construction project.
- Scale successfully. Our deep understanding of pharmaceutical R&D, the pharmaceutical biotech process, and how to scale from a laboratory, through to production for clinical trials and then large-scale manufacture means that we can support you to meet your business objectives and remain within regulatory compliance.
- Repeat business. Many of our clients return to us with repeat business, which is testament to the quality of delivery and care that our teams take with every project. This high level of satisfaction also generates enquiries as a result of recommendations.