Key2Compliance excels in QA Services

Key2Compliance can help companies in the pharmaceutical, medical device and in vitro diagnostic industry to avoid the pitfalls that regulatory requirements may present. With a strong offer in Quality Assurance, Key2Compliance can help clients reach the next level – all the way from development to commercial phase.

For individual innovators or SMEs, it can be difficult to keep track of the regulatory requirements concerning their activities. Failing to meet requirements can be costly, possibly leading to rejection of applications for clinical trial or market introduction, loss of customers or even loss of licence to operate.

Quality Assurance (QA), aims to ensure the correct quality of the product, and includes activities that differ depending on the phase and type of company. Even when the knowledge and awareness of regulatory requirements and QA is high, many small and medium-sized companies lack in-house resources to operate all QA activities without external support.

Key2Compliance offers services in Regulatory Affairs, Quality Assurance, Biological Evaluations and Toxicology, and Clinical Development services for Pharmaceutical, Medical Device and IVD companies. They have the expertise and experience required to support in all stages; from development, through approvals to commercial manufacturing and distribution.

Within Pharma QA Services, Key2Compliance offers consulting services to help companies within pharma to understand and meet quality requirements from authorities, industry, and customers.

Focusing on Pharma QA

The Pharma QA Services is a growing business area within Key2Compliance. Pharma QA offers experts in all GXP areas (GMP; GCP; GDP; GLP and GPVP) and takes on a variety of assignments to help clients reach the next level of compliance.

“We assist companies of all sizes, but it is mainly small to medium-sized companies that lack the internal resources to run their own QA projects. To them, our QA team can offer comprehensive services from clinical phase and all the way to commercial manufacturing and distribution”, says Charlotta Hjerpe, Director Pharma QA at Key2Compliance.

“We can be so much for one and the same customer,” says Charlotta, and continues: “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”, Charlotta explains further.

To the next level

Key2Compliance has offices in Stockholm, Gothenburg, Lund and Copenhagen, and is currently planning the move of the Gothenburg office to GoCo Health Innovation City during spring 2023. This will most likely present even more opportunities and enable the expert teams at Key2Compliance to even better assist in taking the Gothenburg-based Pharma, Medical Device and IVD companies to the next level.