This is how Key2Compliance will make the complex easier in the pharma industry

A natural addition to Key2Compliance's services

Charlotta Hjerpe is the Director of the new business area Pharma QA. During her career so far, she has worked in several different parts of the pharmaceutical industry as a project manager, operations manager, quality manager and quality director. With her broad experience, Charlotta knows a lot about the industry. "The regulations the companies in the Pharma industry need to follow are often complex and not always so easy to interpret. Our job is to make the complex easier and help our customers interpret and implement the rules effectively to comply with the regulations while developing a long-term sustainable business. We want to help them reach an optimal level of regulatory compliance without investing too much time and resources."

Anna Lundén is the Strategic Director of Key2Compliance's Pharma division as well as one of the founders and owners of Key2Compliance. She has noticed that consulting has always walked hand in hand with training and that her customers have needed hands-on support and guidance in different quality topics in addition to training. As an expert consultant with a passion for solving difficult challenges, Anna saw it as a natural step to expand Key2Compliance services to include Pharma QA. "Everything we do at Key2Compliance is connected. We can do audits, provide trainings and give expert support. With our new Pharma QA team, we can now provide services and training related to all GxP areas to ensure our customers meet all the complex regulatory requirements regardless of company size or what phase it's in. We can help both startups, and larger companies achieve efficient quality management in different phases and aspects of the product life cycle."

By their side, Charlotta and Anna has dedicated professionals with extensive industry experience. Lina Philipson is a former nurse with experience in audits, revisions, quality management systems (QMS) and QA consulting. Marika Lundin, with a background in both research and manufacturing has experience in QMS and eQMS as well as training and consulting in e.g., project management, validation, qualification and aseptic assurance. This team of experts stand ready for helping companies of different sizes, serving different industries and in different product development stages with a broad range of services. And the team is still growing. "We're still recruiting senior consultants and experts," says Charlotta, "But we also have our extensive network of sub-consultants that ensures we can always find the expertise needed. Whatever the problem is, this Pharma QA team can always help."

Understanding the customer's needs

The Pharma QA team wants to be the go-to consulting partner in Pharma to all types of companies in all product development stages, from those in the development stages to those that have products out on the market. "No matter who you are, what stage you are in, or what GxP area you are interested in right now, we will be able to help you," says Charlotta, "We adapt our services to the customer's needs. We understand the customer's situation and what phase they are in; we know the requirements and the expectations; we can adapt them according to their needs. That way, we can find the balance between what's required and what's enough. There is so much for these companies to keep track of, and we can help set the bar at the right level, not too low or too high."

The Pharma QA team can support their customers with e.g., audits and inspections, GAP analysis, training, design of QMS and quality processes, implementation of eQMS, validation support, coaching and expertise, and so much more. "We can be so much for one and the same customer," says Charlotta, "We can perform their self-inspections, train their staff, audit their suppliers, be their QA-manager, build their quality system, qualify their equipment and validate their processes, etc. Or we can do a single audit or provide a few hours of expert support for shorter assignments. We want to create long-term collaborations where our customers know that they can always turn to us for whatever help they need at a certain phase. We have a lot of knowledge about how to interpret the rules and about best practices. If in need of a quality system we can quickly produce a proposal for the documentation needed for different types of companies, and when in need of an audit we can quickly find an experienced auditor with the appropriate background. We can also be the experienced external expert that can guide each company to solve various quality problems and give support in quality issues, so these companies can focus on making the best and most secure product possible."

For Anna Lundén, Pharma QA is a natural expansion of Key2Compliance: "One of the most important parts of Key2Compliance is the collaboration we have between different teams. We work closely together with many experts, and if one of us doesn't have the answer, we know who does. Our combination of trainers and consultants also means that we can see things from several different perspectives and always be both experienced and up to date. We also understand the business needs of the customers. With our experience from both MedTech and Pharma, we can truly make the complex easier for our customers. And this is just the beginning. Pharma QA will have so much more to offer."