Regulatory Affairs Services – Qualitätswandel Dana Graupner GmbH

Across its wide and varied portfolio of services and specializations, Qualitätswandel Dana Graupner GmbH has the overall aim of helping life sciences companies to improve the regulatory compliance that is now essential for modern pharma, biotech and medical device businesses.

This work involves advising and supporting stakeholders in complying with regulatory requirements for pharmaceutical and medical devices, including life cycle and submission support in regulatory affairs management.

Transforming businesses

Perfecting Regulatory Affairs (RA) should be seen as far more than a necessary burden. The guidelines produced by regulators such as the European Medicines Agency (EMA) and standards bodies such as the ISO and ICH do more than just makes quality stipulations. In most cases they also serve as guides and benchmarks for the best methods, equipment and processes to use in laboratory and manufacturing quality control, production, packaging, etc.

Through its regulatory compliance interactions with clients, Qualitätswandel also helps life sciences companies transform their structures, processes and systems to achieve real efficiency improvements and transform their processes.

Regulatory challenges

Life sciences companies typically face several challenges in assuring regulatory compliance. These include Change Control (managing and documenting variations in manufacturing processes, drug formulations, materials, etc.) where it is not only internal factors that are changing but also the surrounding regulatory regime, with constant updates to be considered.

This in turn leads to problems with dossier preparation, where even minor discrepancies or information gaps can have severe consequences. Adding to the complexity, modern regulation is moving beyond traditional ‘single product’ pharmacovigilance (PV) concepts to place greater emphasis on translational safety , in which the entire life cycle of a product and its evolutions need to be considered and managed.

The sheer volume of work involved in regulatory compliance can be overwhelming, particularly for smaller to medium sized companies, where overstretch of people and resources is a constant reality.

Qualitätswandel Regulatory Affairs Portfolio

Qualitätswandel offers a wide range of consultancy and management services to help life sciences companies overcome these hurdles. These include:

• Project management: specializing in quality assurance and laboratory practice.
• Regulatory compliance: including admissions support and regulatory affairs management.
• Quality Management Systems: in accordance with ISO 9001, ISO 13485, 21 CFR Part 820, EU GMP and ICH Q10 guidelines.
• Document support: Writing of technical documents to meet ISO and GMP standards, including translation and digitization of manufacturing documents.
• Query Processing: including complaints, deviations, changes and CAPAs.
• Cleanrooms and Equipment: Planning, qualification and maintenance in accordance with EU-GMP guidelines Annex 1 and ISO 14644.
• Risk assessment: according to ISO 14971 and ICH Q9.
• Method and Process Validation according to CLSI Guidelines, ICH Q2, EU-GMP Guidelines Annex 15, USP <1225>, 21 CFR Part 211.
• CSV Computer Systems Validation in accordance with GAMP 5 guidelines.
• Raw Material and Supply Management: according to ISO 9001, ISO 13485, ISO 15378, EU GMP Guidelines Part 1 chap. 7 and Annex 8.
• Stability study organization to comply with ISO 13485, ICH Q1 and 21 CFR Part 820 standards.
• Audit services: Planning and execution as co- and lead auditor.
• Inspection services: Support during inspections by authorities and notified bodies.
• Training: Creation of bespoke staff training courses for delivery on site or online.

Qualitätswandel Regulatory Affairs specialist Elisabeth Lieschke says clients often need particular assistance in managing their communications with regulatory authorities, in keeping abreast of latest EU guidelines and EudraLex standards, and in technical requirements in such aspects as labelling and artwork.

“We find that we need to become particularly involved in the overall lifecycle management of products and in verification of guidelines to take account of latest updates,” says Elisabeth Lieschke.

“The challenges become particularly complex when dealing with biotech products, ATMPs, gene therapy or somatic cell medicines. These have more complex dossiers and manufacturing processes and are also more complicated to manage in their IPC in process controls and change processes, to provide verifications and communicate variations,” Elisabeth notes.

Qualitätswandel prides itself on being particularly expert on detailed aspects of regulatory intelligence latest, which means it is able to help clients anticipate emerging and impending changes, such as safety relevant issues, latest labelling requirements and variations in guidelines. It maintains close relationships with German regulation agencies such as Regierungspräsidium, which helps it monitor the EudraLex environment more generally.

Its network of consultants are also well-versed in the demands of digitalization and regulatory demands for data security and data integrity and maintenance of electronic batch records.

Elisabeth Lieschke says a significant proportion of the consultancy’s workload relates to this field, especially in transferring previously paper-based manufacturing protocols, along with dossier changes and helping companies to prepare for audits.

“Overall, we are usually able to help companies make significant improvements to their technologies and organizational efficiency as by-products of our regulatory engagements with them” she comments.

“And of course, we can also help them clear what may be considerable backlogs of regulatory documentation that may require attention. We act as a resource booster in that regard,” she explains.

Resources

Click on Qualitätswandel: Your External Partner for Quality Management Systems to learn more (German language: Google Translation Available).
Click on Advice through Leadership to watch video.
Click on Qualitätswandel Podcast for Spotify-hosted discussions on topics such as GxP, ISO, quality management and regulatory affairs.
Click on Elizabeth Lieschke for profile and CV.
Click on Elizabeth Lieschke to connect on LinkedIn.