GxP and Medical Device Compliance Services

Consultys - LifeScience Consultancy

Our offerings enable regulated companies to accelerate compliance and get to market faster while reducing costs and improving efficiency

 
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Consultys, the market reference in pharmaceutical biotech and medical device consulting

Consultys Group
Consultys  is a specialist LifeScience consulting firm. With more than 360 experts working in France, Belgium, Germany and Switzerland on major engineering and compliance projects for the world’s leading pharmaceutical, medical device and biotech companies.

Consultys links operational compliance, quality, regulatory, own solutions and technology in ways that master complex business challenges to help its LifeScience clients exploit their existing strengths and develop new capabilities by combining its experience and innovative thinking across in the regulated environment.

Consultys is part of Vulcain Engineering, a leading player in the consulting and engineering industry which employs 1,200 employees and reached €140m in turnover in 2018.

Consultys Switzerland
Driven by a company philosophy based on human values, proximity and professional excellence, Consultys Switzerland is offering dedicated engineering and compliance services to our more than 50 clients in the Pharmaceutical-, Biopharma-, Veterinary- and Medical Device Industry.

We enable our clients to accelerate compliance and go to market faster while reducing costs and improving efficiency. We operate locally from our project offices in Lausanne, Zug and Opfikon.

 
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Our service portfolio at a glance

Consultys clients look to us when they require deep industry knowledge and excellent compliance experience. We provide experienced professionals
who can blend context, vision and detail, bridging the gaps across company objectives and day-to-day business.

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Galenic Development, Formulation, Analytical Development, Upstream, Downstream, Scale-up, Biostatistics

Development, Validation, Industrial Transfer, Sterilisation, Manufacturing, Cleaning

Feasibility studies and process safety from design to commissioning, Equipment Qualification (IQ OQ PQ) / Utilities / Premises, FAT / SAT, Maintenance, Supply Chain

Quality Assurance, Quality Management System, Quality Control, Deviations, CAPA, CCR, Audits, Non-conformance, Complaints procedure

Technical-Regulatory Affairs, Redaction of Module 3, Publishing, Renewals of MA, Variations

Project Management, Planning / Cost / Quality, Risk Management, Key Performance Indicator (KPI)

 

Expertise by Industry

The Consultys team includes international GMP consultants and experts who have previously held senior roles within the industry and are able to consult on GMP compliance and QA other related issues.

 

Pharmaceutical, Biopharma and Veterinary Manufacturer

Consultys offers a range of Architectural, Engineering, QA and Validation and GMP Services to Pharmaceutical, Biotech and Veterinary manufacturing industries to meet Good Manufactoring Practices (GxP).

We provide interim resources, GMP consulting and training on regulatory GMP compliance, product registration, qualification & validation and continuous improvement of manufacturing processes and facility design and construction.

 

Medical Device Manufacturer and Supplier

Consultys offers a wide range of Quality Assurance (QA), regulatory, representation, and UDI/labelling consulting services to medical device and IVD companies.

We provide services and medical device regulations, such as the US FDA 21 CFR Part 820,  the ISO 13485 Quality Management System for Medical Devices and ISO 14971 Risk management for medical devices.
 

 

Office Location

 

Our Consultys Switzerland Headquarters is in Zug, Switzerland. Consultys has dedicated project offices in different cities and counties. You can find an office near you in our project office section.

 
 

QUESTION & ANSWERS
COMPANY

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