PM

Project Management

RM

Risk Management

QARA

Quality Assurance and
Regulatory Affairs

BA

Business Analysis

KM

Knowledge Management
BPA
Business Process Management

Quality Assurance & Regulatory Affairs

Superior flexibility and tailor-made quality assurance strategies assure seamless quality system integration or optimization into customer´s existing systems. Once systems are established, Avanti Europe can support in process optimization with trained six sigma green and black belt personnel as well as introducing lean principles to processes.

https://youtube.com/watch?v=SVa5gPkLqvE%26vq%3D1080

Expertise includes, but is not limited to:

  • Development of bespoke quality systems (e.g. integration of medical devices QSR into pharmaceutical PQS)
  • Known quality systems are ISO9001, ISO13485, GMP, ISO16949
  • Quality audits, gap assessments and quality due diligence audits
  • Verification and Validation (incl. for software)
  • Investigations, problem solving and root cause analysis
  • Corrective and Preventive Action (CAPA)
  • 8 disciplined approach to problem solving (8D)
  • Kepner Tregoe problem solving
  • Lean and six-sigma integration into existing QA systems
  • Quality by Design implementation into existing QA systems
  • Customer-specific training (in-house or as eLearning)

Avanti Europe´s regulatory affairs experts know the medical device and pharmaceutical sector and excel in providing customer specific support for medical devices, pharmaceuticals and combination products (both for medical device and pharmaceutical route).

Expertise includes, but is not limited to:

  • Submission preparation for combination products and medical devices (global or country specific)
  • RA strategy development for the product/project portfolio
  • Changes to dossiers and/or re-certification
  • Customer-specific training (in-house or as eLearning)