What We Do
Quality Consultancy
Our method of objectively challenging a project in a consultative manner has led to some extremely beneficial and innovative outcomes for our clients.
REGULATORY FILINGS & QP SERVICES
Preparation and submission of manufacturing licence, IND, NDA, DMF and BLA
MOCK INSPECTIONS, COMPLIANCE AUDITING & TRAINING
FDA (CDER, CBER & CUM), ISO 9001, 14001, 20000 & 27001, OSH 18001, EU GMP, UK MHRA, UK Home Office inspections
Development and delivery of in-house training programmes
COMPLIANCE
Safety, health, environmental
OPERATIONAL EFFICIENCY
GMP and Operational Excellence, Quality by Design, Environmental Control and Energy Saving
MASTER PLANNING
New facilities, renovations, expansion plans
VALIDATION
Computer, equipment, process, cleaning, supply chain, training
Design & Engineering
Through our in-house talent we are delighted to offer a full suite of master-planning, location and site analysis, feasibility design, concept design, preliminary engineering and detailed design, and GMP qualification support. Implementation as standard of industry best practice and cutting edge design technologies.
All our projects are executed in a BIM environment so clients benefit from:
- Phased delivery to suit operational / production / budget constraints
- Detailed design packages that articulate client requirements
- Regular 3D reviews of the project as it evolves
- Clash free construction and improved quality
- Certainty, eradicating issues before they impact
- Saving time and money, whilst ensuring best project outcomes throughout
Project & Cost Management
Proactive project management ensures that all aspects of delivery are correctly planned, monitored and controlled. We provide management of programmes, risk, reporting, change control, safety, supply chain, costs and commercials. Operating a collaborative, partnership approach we ensure your project is delivered to meet objectives.
Construction
Scitech construction disciplines cover a wide range of services that can be tailored to suit any requirement – traditional consultancy, design and build, construction management, management contracting, commissioning and construction consultancy. Our specialists have a wealth of experience in laboratories, development sites, primary and secondary manufacturing, packaging facilities, logistics operations, and diagnostic centres.
Quality & Validation
Scitech have extensive experience in helping clients with management of regulatory and operational challenges, compliance, management of headcount, risk management and efficiency improvements.
Outsourcing helps our clients to focus on core business issues, achieving current best practice, whilst gaining access to new skills and technology. Talk to us about how this could work for your business.
- Quality Consultancy
- Commissioning, Qualification & Validation
- IT, Automation & Computerised System Validation
- Supply Chain Validation
- GMP Training & Coaching
The Scitech Process
Proactive project management ensures that all aspects of delivery are correctly planned, monitored and controlled. We provide management of programmes, risk, reporting, change control, safety, supply chain, costs and commercials. Operating a collaborative, partnership approach we ensure your project is delivered to meet objectives.
Design & Engineering
Before we start on site we have a fully coordinated multi discipline approach with implementation as standard of industry best practice and cutting edge design technologies. This time spent during the design stage is invaluable to achieve a smooth, trouble free construction and commissioning stage.
Site Set-up
An established site set-up is critical to safe completion of the project – well considered safe conditions through to safe practices encourage excellence. We understand our clients still need to function whilst construction is carried out. Close liaison with our clients ensures this is achieved.
Pre-construction consultancy
The better the forward planning, the better the outcome. Our early pre-construction engagement ensures certainty, eradicates issues before they can impact, saves time and money, and ensures the best outcomes for every aspect of the project.
Construction
Working closely with our engineering teams our highly skilled and specialist construction team work to ensure that a new or remodelled facility is completed to the highest standard. We employ a Zero strategy – safety on our sites is a critical ingredient, we do whatever it takes to achieve zero incidents and accidents.
Quality & Validation
Engagement during the design phase ensures the design meets all required GxP standards and minimizes the risk for the subsequent phases of qualification. During commissioning our team can ensure that all applicable test methods can be used to support the qualification and plan the qualification phases. Prior experience has helped Scitech adopt a streamlined approach to commissioning and qualification, to aid early handover of the facility to the client.
Completion
From design through to completion, Scitech manage the whole process to ensure we meet our client’s expectations and provide a smooth and efficient handover, so our clients work can really begin.