Life Sciences Consulting
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Rob Stijlen
Rob Stijlen

ARCONDIS Life Sciences Consulting

Added value for life sciences in processes, IT and compliance

ARCONDIS is the largest consulting company exclusively specialized in the life science industry in Switzerland, Germany and Austria. Benefit from our unique expertise for your projects – contact us!

Our interdisciplinary teams from Basel, Frankfurt and Munich have been taking care of local and global projects in the fields of processes, IT management and compliance for medium-sized companies and global corporations in the pharma & biotech and medical devices industries as well as for agricultural, chemical & food manufacturers.

News

MDSAP – Medical Device Single Audit Program

MDSAP – Medical Device Single Audit Program
January 22, 2018

The stated aim of the Medical Device Single Audit Program (MDSAP), which officially took effect in June 2017, is to reduce audit effort for quality management systems (QMS) for authorities as well as for medical device companies. The ... More
Top Employer 2018

Top Employer 2018
February 14, 2018

The magazine FOCUS-BUSINESS has rated ARCONDIS one of the top employers in the areas of “consultation” and “SMEs” in German-speaking countries, on the basis of an independent data collection. Overall, ARCONDIS was ranked in place 211 out of the ... More
Webinar Serialization

Webinar on Serialization [Free – German only]
January 9, 2018

Falsified medicines present a major threat to public health, as well as damaging the reputation of pharmaceutical brands. The Falsified Medicines Directive (FMD) determines that the serialization of licensed medical products will be a legal ... More

References

Falsified Medicines Prevention Shortview

Prevent falsified medicines

Preventing the release of falsified medicines through rollout of new processes, SOPs and IT systems. Achieving full transparency of the company’s complex supply chain. Establish compliance towards GMP regulations, including EU GMP Annex 16.

Setup of a Global IT Quality Management System

Setup of a Global IT Quality Management System

Set up of a new IT Quality Management System (IT QMS) according to GAMP and ITIL including creation of directives, SOPs, templates and forms.

Unbundling IT infrastructure

IT Infrastructure Unbundling Program for Divestment Initiatives

Resource saving unbundling of the IT infrastructure during a divestment process in several manufacturing sites. Execution of the global program and project management.