Established 2004

Bruun & Maté AB is a management consulting and technology services company located in the Oresund area in Southern Sweden.

Committed to delivering high quality services, Bruun & Maté AB collaborates with its clients to help them become high-performance businesses and fulfill regulatory expectations. With deep industry and business process expertise, and a proven track record, Bruun & Maté AB help clients improve their performance.

About

Using our industry and business-process knowledge, our insight into and access to existing and emerging regulatory requirements and technologies, we identify new regulatory, business and technology trends and formulate and implement solutions for clients. 

Services we offer

We offer our clients full-service consulting within different areas. The knowledge of our senior consultants has a unique balance between regulatory compliance and information technology.

Quality

Q2S, Quality as a Service -
Long term Collaboration (Assignment)

Provide the following services:

  • Hire of QP (Qualified Person)
  • Hire of Responsible Person (Distribution of pharmaceuticals)
  • Hire of department QA / QC Managers
  • Hire of project QA Managers
  • Hire of Quality Engineer (e.g. Complaint investigations, Risk Management, Change Management)
  • Analysis and Reporting – PQR, APR etc.

Provide management and responsibility of a QMS:

  • Develop and Maintain a compliant QMS
Quality

Compliance

Audit services

EU GMP, GDP, Medical Devices

  • Suppliers, Laboratories, internal QA/QC departments, CMO/CRO
  • distributors, repackers, transport companies of pharmaceuticals
  • EU GMP, EU GDP, MDD/MDR, ISO 13485, 21CFR820, 21CFR210
  • IT Processes, In-house IT departments, Software Development Processes
  • Due-diligence of QMS organizations and 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
Services related to clean rooms / sterile environment

Compliance

Security

Information Security related services

Records and Information Management

  • Routines for Regulatory and Business Critical information

Data Integrity

  • Data integrity is a prerequisite for the regulated healthcare industry

GDPR

  • Establishment of GDPR framework
  • GAP analysis / Improvement of GDPR processes
Security

Project Management

Senior Project Managers

IT system introduction / roll out, e.g.

  • SAP R/3
  • Movex M3
  • EBR
  • LIMS
  • HR & Payroll

Serialization and aggregation projects

Product Lifecycle Management (PLM)

  • Initial conception
  • Design control (R&D)
  • Industrialization
  • Product care
  • Product decommissioning
Project Management

Contact us

Get in touch

Attila Maté

CEO
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Gabriel Held

Senior Consultant
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Eva Wendt

Senior Consultant
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Paul Scholten

Senior Consultant
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Roger Petersson

Senior Consultant
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Catharina Ljungqvist

Senior Consultant
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Maria Rosendahl

Senior Consultant
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Jörgen Lidén

Senior Consultant
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Sven Lekander

Senior Consultant
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Vacancy

Senior Consultant
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