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

Key2Compliance has always been focused on assisting companies in the Life Science area by offering customer-oriented solutions to solve any need of our customers. While helping our customers with training and courses, we have noticed the need for additional help and support related to quality assurance (QA), quality management and quality strategy. With all the expertise and experience within Key2Compliance, we want to share all this knowledge and help the companies in the pharmaceutical industry understand the regulations and help these companies practically meet the requirements. Now we can finally present our brand-new Pharma QA team: a carefully chosen group of experts that can make the complex easier. Meet our Pharma QA team!

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."

For more information, please contact;
Terese Hedin, Marketing Director
+46705610092
[email protected]

Key2Compliance focuses on helping companies in the medical device and pharmaceutical industry. We are a full-service partner that offers complete solutions in all aspects of our customers needs, including but not limited to training in regulations, consultation, and compliance.

Så ska Key2Compliance göra det komplexa enklare inom läkemedelsindustrin

Key2Compliance har alltid varit inriktat på att hjälpa företag inom Life Science genom att erbjuda kundorienterade lösningar för våra kunders behov. När vi har hjälpt våra kunder med utbildningar och kurser har vi även märkt behovet av ytterligare stöd relaterat till kvalitetssäkring (QA), kvalitetsledning och kvalitetsstrategi. Med all den kompetens och erfarenhet vi har inom Key2Compliance vill vi dela med oss av all den kunskapen för att hjälpa företag inom läkemedelsindustrin att förstå regelverken och att praktiskt kunna uppfylla kraven. Nu kan vi äntligen presentera vårt nya Pharma QA-team: en noggrant utvald grupp experter som kan göra det komplexa enklare. Möt vårt Pharma QA-team!


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

Key2Compliance has always been focused on assisting companies in the Life Science area by offering customer-oriented solutions to solve any need of our customers. While helping our customers with training and courses, we have noticed the need for additional help and support related to quality assurance (QA), quality management and quality strategy. With all the expertise and experience within Key2Compliance, we want to share all this knowledge and help the companies in the pharmaceutical industry understand the regulations and help these companies practically meet the requirements. Now we can finally present our brand-new Pharma QA team: a carefully chosen group of experts that can make the complex easier. Meet our Pharma QA team!


Susanne Søeborg ny Country Manager för Key2Compliance i Danmark

Medicinteknik- och läkemedelskonsulterna Key2Compliance har sedan en dryg månad öppnat ett kontor i Danmark. Nu har den danska verksamheten fått en Country Manager.
- Jag ser fram emot att hjälpa danska företag att få ut sina produkter på marknaden, säger Susanne Søeborg.


Susanne Søeborg new Country Manager for Key2Compliance in Denmark

Medtech and pharmaceutical consultants Key2Compliance opened an office in Denmark just over a month ago. Now, the Danish business has got a new Country Manager.
"I look forward to helping Danish companies get their products on the market," said Susanne Søeborg.


Key2Compliance establishes office in Denmark

Medtech and Pharmaceutical consultants Key2Compliance are now expanding outside Sweden's borders for the first time. Recruitment has already started for the Danish office in Copenhagen.
"We already have a number of Danish customers and have completed numerous courses and training there. This was a natural step", said CEO Jan Hellqvist.


Key2Compliance etablerar sig i Danmark

Medicinteknik och läkemedels-konsulterna Key2Compliance expanderar nu för första gången utanför Sveriges gränser. Rekryteringen har redan startat för det danska kontoret i Köpenhamn.
- Vi har redan ett antal danska kunder och har genomfört en mängd kurser och utbildningar där. Det här var ett naturligt steg, säger VD Jan Hellqvist.


Key2Compliance startar nytt affärsområde för klinisk utveckling av medicinteknik

Key2Compliance AB, som ägs av Symbioteq Holding AB, anställer elva personer för att starta ett nytt affärsområde för klinisk utveckling.
- Detta gör vårt erbjudande helt unikt i Sverige, säger Jan Hellqvist, VD på Key2Compliance.


Symbioteq Holding AB köper Key2Compliance AB

Ett bredare tjänsteutbud med ett större fokus på utbildning och kurser - det blir resultatet när Key2Compliance AB blir ett helägt dotterbolag till Symbioteq Holding AB. I samband med affären slås bolagen även ihop rent fysiskt och flyttar till nya lokaler i Gamla Stan i Stockholm.


Symbioteq utser ny VD

Symbioteq Kvalitet AB ("Symbioteq" eller "Bolaget") meddelar att Jan Hellqvist tillträtt som ny VD 2020-01-01.


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