Drugs & Therapy

Bernd Renger Consulting

Bernd Renger Consulting is providing Consultancy Services for Pharmaceutical and related Industries including API, excipient and packaging material production and pharmaceutical testing laboratories; also serving Medical Device Manufacturers.

  • GMP and GDP compliance checks including remediation plans
  • Design and Implementation of Quality Systems, including Deviation Management, CAPA, Complaint Management, Change Control, Batch Record Review, Document Management, and Risk Management
  • Preparation for FDA and National authority inspections – gap and risk assessment, mock inspections, audit preparation projects
  • Inspection Finding Remediation Services (including FDA Warning Letter and 483s)
  • Review and optimization of manufacturing and quality operations with emphasize on sterile and aseptic processes
  • Contract Auditing Services – All types of pharmaceutical or medical device operations; manufacturing including aseptic manufacturing; Quality Systems, API manufacturing, excipient manufacturing, packaging components including glass tube manufacturing
  • In-house training: National and international regulations, basic GMPs, relevant cGMP Guidance
  • QP Services

Competences

Consulting, GMP, Regulatories, Audits, Batch Record Review

Address

Mögginger Steig 28
DE-78315 Radolfzell

Web: www.renger-consulting.com

Contact

Dr. Bernd Renger
Geschäftsführer
Tel.: +49 (0)7732 – 93 82 77
Mobil: +49 (0)160 – 96 96 32 92
E-Mail: bernd.renger@br-consult.eu