About
maj 2022
Bruun & Maté AB joins Epista Life Science Group to increase industry impact
To address the Life Science industry’s increasing demand for service partners with a versatile skillset, Epista Life Science, a compliance and business consultancy headquartered in Denmark with subsidiaries in Sweden and Germany, has joined forces with Bruun & Maté AB, a respected Swedish consultancy focused on quality, compliance, and security. The acquisition of Bruun & Maté AB became official on April 1, 2022. The union enhances both companies’ ability to help clients drive the innovations that improve health care around the world. It does this by combining capabilities within business, leadership, and technical skills; strategic and operational experience; and international expertise with local resources.
Robert Pettersson, Managing Director of Epista Life Science Sweden says the acquisition adds value to the Swedish Life Science industry: “We’ve created a robust pool of industry experts. Most of our new colleagues have 20-30 years of experience, working with some of the largest companies in the Life Science industry. This extends the impact we have on our clients, helping them achieve their business goals.”
Klavs Esbjerg, CEO of Epista Life Science agrees, and adds: “Yes, impact is what we want. We’ve built a very strong team and we firmly believe that this strength brings a responsibility to make a positive impact on our industry. Our union with Bruun & Maté is our latest step on this journey, with many more to come.”
Attila Maté, founder of Bruun & Maté, concludes: “We’ve been on the lookout for a suitable partner for quite some time. Epista is a great fit. We feel confident joining their team because they share our standard of excellence when it comes to the way we work with clients. And we have an outstanding cultural fit when it comes to developing our teams.”
With Bruun & Mate’s addition, the Epista Life Science group now provides services worldwide through six offices in Denmark, Sweden, and Germany.
Contact attila.mate@bruunmate.com for questions or additional information.
Quality
Q2S, Quality as a Service - Long term Collaboration
We provide following services:
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Hire of QP (Qualified Person)
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Hire of Responsible Person (Distribution of pharmaceuticals)
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Hire of Person Responsible for Regulatory Compliance (PRRC)
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Hire of department QA / QC Managers
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Hire of project QA Managers
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Hire of quality engineers (e.g. complaint investigations, risk evaluations, change and deviation management)
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Analysis and reporting – PQR/APR, Elemental Impurities, Residual Solvents etc.
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Development and maintenance of a Quality Management System (QMS)
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Outsourcing of different QMS areas
Compliance
Audit services
EU/US GMP, GDP, Medical Devices
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Suppliers, Laboratories, internal QA/QC departments, CMO/CRO
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Distributors, re-packers, transport companies of pharmaceuticals
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EU GMP, EU GDP, MDD/MDR, ISO 13485, 21CFR820, 21CFR210/211
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IT Processes, In-house IT departments, Software Development Processes
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Due diligence of QMS processes
QMS related services
GAP analyses, Establishment, reconstruction, extension of QMS systems
- EU GMP, GDP, MDD/MDR, ISO13485, 21CFR820, 21CFR210 or other regulatory requirements
Validation and qualification services
- Manufacturing, laboratories, administrative systems, HVAC etc.
Serialization and aggregation
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Services related to clean rooms / sterile environment
Security
Information Security related services
Records and Information Management
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Routines for Regulatory and Business Critical information
Data Integrity
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Data integrity is a prerequisite for the regulated Life Sciences industry
GDPR
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Establishment of GDPR framework
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GAP analysis / Improvement of GDPR processes
Project Management
Senior Project Managers
IT system introduction / roll out, e.g.
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SAP
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Movex
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EBR systems
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LIMS
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Serialization and aggregation systems
Product Lifecycle Management (PLM)
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Initial conception
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Design control (R&D)
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Industrialization
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Product care
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Product decommissioning
Remote Audits
Why remote audits?
According to current regulations, an audit of the supplier is usually needed as part of the supplier qualification. When the world situation is as it is with travel restrictions, many of these audits cannot be performed. This can be solved with a remote audit (distant assessment), which can be seen as a paper-based audit but with the addition of performing parts of the audit via a web meeting.
Bruun & Maté has developed a "best practice" on how a remote audit can be done. The main steps are:
A risk assessment is performed in collaboration with the customer to evaluate what is important that it is ensured during the audit.
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A detailed audit plan is prepared and sent to the supplier to ensure that they have the right people in place and have the necessary technical equipment.
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The remote audit is conducted based on the risk assessment and the documents obtained from the supplier before the audit.
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An audit report is compiled, and the risk analysis is updated with the results of the audit. An assessment is made of whether a subsequent on-site audit needs to be done when it becomes possible to travel again.
If an on-site audit is considered necessary, it will be done in areas that could not be inspected during the remote audit. This means that this will be a shorter audit focusing on the areas that need further review according to the risk analysis.
We have several senior auditors who can tailor a solution to suit your needs. If you want help with an audit, please contact us.
