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
Safety, health, environmental
GMP and Operational Excellence, Quality by Design, Environmental Control and Energy Saving
New facilities, renovations, expansion plans
Computer, equipment, process, cleaning, supply chain, training
- Quality Consultancy
- Commissioning, Qualification & Validation
- IT, Automation & Computerised System Validation
- Supply Chain Validation
- GMP Training & Coaching
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.
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.
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.
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.
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.