Bernd Renger Consulting (BRC) activities include services and support for clients working in the GXP regulated pharmaceutical industry, including biopharmaceutical and OTC, sterile or aseptic manufacturing and API production.
BRC are specialized in assisting clients by providing expertise, on site support and on site training courses covering implementation and optimization of Quality Systems according to FDA, EU GMP and PIC/S with emphasis on:
- Risk Management & risk-based GMP interpretation
- CAPA and Deviation/Complaint Handling
- Batch Release and QP Services
- Laboratory & Analytical Operations including OOS (Out of Specification) Result Handling
- Supplier Quality Assessment and Auditing (Finished Product, API, Excipient and Packaging Material Suppliers, Contract Facilities, Warehouses and Testing Sites)
- Operational Excellence
- Inspection Preparation (FDA, National Authorities)
In contrast to BRC's activities, PharmDev's focus is on activities prior to regulatory submission but with similar scope apart from this difference.
Your partner for high quality eCTDs regulatory submission services and EVMPD support
Our highly experienced team of regulatory affairs and documentation professionals provides a comprehensive set of services that covers all aspects of the electronic drug regulatory affairs business.
It includes electronic submission services like eCTD or NeeS compilation, submission hosting, individual processing of submission documents as well as consultancy in all questions of electronic drug regulatory business.
In addition to our electronic dossier services we support the registration of your medicinal products in xEVMPD in acc. to Article 57(2) second subparagraph of Regulation 726/2004.
We also provide consulting and training regarding eCTD and xEVMPD requirements and support the implementation of electronic submission and tracking systems and their related business processes in the global pharmaceutical industry.