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At the heart of Life Sciences future
From pedometers to applications that manage cardiovascular risks and monitor diabetes, there has been a boom in e-health applications in recent years. Between 2015 and 2016 the estimated number increased from 165,000 to 295,000, and the market is expected to triple by 2020.*
Digitization is being used by pharmaceutical companies and in the field of life sciences to help find a balance between patient centricity and performance. These innovations make it possible to develop patient-centered medical products and services, and are bringing about a change in prevailing business models. These companies are shifting from the sale of simple products to the sale of complex health care solutions, such as a drug with a smart or connected medical device, supported by patient services.
AKKA believes that technological developments will create new opportunities with regard to connected objects, websites providing day-to-day advice and mobile health care applications that will generate data from real-life situations. These innovations will advance the concept of personalized medical care, but will also raise questions about the quality, ownership, use and security of data.
* source: Research 2 Guidance
Regulatory affairs and clinics
AKKA Life Sciences provides experts on demand as well as offering a full remote service through its Regulatory Affairs and Clinics competence center. On-site service in customer facilities is also available from consultant teams comprised of experienced professionals who are capable of analyzing the regulatory compliance on field.
Through our competence centers for the conception and certification of medical devices, AKKA Life Sciences provides experts on demand as well as a fully remote service.
AKKA Life Sciences provides a pure consulting approach with its team of highly skilled experts, along with operational support delivered by experts on demand.
AKKA Life Sciences provides a pure consulting approach through our core consulting team of experts and operational support provided by experts on demand. This builds on our expertise in complex project management, innovation, robotization, automation and digital.
In the life cycle of each project, commissioning and qualification processes are the last required steps to ensure reliable and compliant installations and equipment for a safe production and an optimized quality. We provide comprehensive expertise and support.
Manufacturing is a very challenging and changing environment in which AKKA supports its clients in delivering their daily business priorities along with specific revamping projects.
Our experts are present on the production side and also on the quality side to make ensure daily activities are conducted in compliance with GMP and FDA requirements.
AKKA also provides support with continuous improvement by implementing lean processes.
AKKA Life Sciences provides support across the entire product life cycle, from R&D to packaging, including cross-functional activities such as quality control.
AKKA provides support across the entire product life cycle, from R&D to packaging, including cross-functional activities such as quality control.
We also perform project management activities, from program management to project coordination.
The development process for each drug, active ingredient, excipient or medical device is a rigorous process. To design and carefully follow the development process during its various phases, it is important to ensure complete compliance with correct production methods, to obtain quality, yield and profitability benefits and meet safety and quality requirements.
It is not enough to have drugs or medical devices capable of revolutionizing the market if we are not able to produce them correctly and profitably. A production plant built according to the regulatory criteria required by national and international laws, conforming with materials and personnel flows optimization, and integrating new technologies of automation and robotization, is often what’s required for competitiveness and profitability. Our expertise covers every aspect of that process.
The increasing complexity of systems, the innovation push through automation and robotization processes, the need for electronic documents storage, the opportunities given by a careful and effective management of analytics, are among the most salient features of the digital era.
Regulatory bodies all over the world have always perceived both the potential and the risks of a greater digitalization of the world, and this is why in recent years the Life Sciences Normative has seen increasing attention paid to computer systems validation.
Considerable attention has always been paid to the “integrity” of the data and to the correct management of documentation. Regulation has always been at the forefront in the Life Sciences sector because the quality and effectiveness of the final product and its traceability plays a fundamental role in the chain of trust that binds the major players in Life Sciences with consumers.
Nevertheless, the growing use of computer systems for both data generation and storage has complicated the process of ensuring data reliability.
New international regulations have become necessary to clearly explain the requirements companies are now expected to meet. We can support customers in all facets of their data integrity needs.
We develop tailored training approaches to address your Life Sciences challenges.