Life Science
Contract Service Organisation
Your trusted and dependable life science consulting partner.
We’re experts in Life Science
Our approach to the complex world of Biotech and Medtech is simple. We take our extensive industry knowledge and comprehensive capabilities and pair them with our in-depth understanding of some of the most important challenges in respect to Regulatory Affairs, Quality Assurance, Engineering and Product Commercialisation.
We leverage our industry experience to support the Life Science companies globally achieve compliance, using an array of consulting, technology and outsourcing expertise.
Contact us today if you’re looking for a bespoke, professional, and authentic end-to-end outsourced service solution.
100% dedicated to Life Science
• We help life science companies achieve compliance by bringing the full strength of our consulting, technology and outsourcing expertise.
• We provide a range of comprehensive capabilities combined with extensive industry knowledge and an understanding of today’s most pressing challenges.
• We are able to support companies on a global scale. Specific know-how in supporting non-EU businesses to develop their activity across Europe.
Our Services
QUALITY ASSURANCE
Our consultants take a risk-based approach to improve quality, and compliance…
REGULATORY AFFAIRS
Our consultants have expertise in EU and US regulations and have many years’ experience…
VALIDATION
Our Validation Engineers can plan, execute, deliver and manage all of your validation needs…
PHARMACOVIGILANCE
Our QPPV network delivers services, especially in the EU. From strategy to audits…
We don’t follow a one-size-fits-all approach. Every package of services is tailor-made to suit your needs.
We offer a comprehensive range of outsourced consulting services aimed at supporting biologics, medical devices and other pharmaceutical products, and facilitating the Research and Development of new products and solutions, as well as assisting with the market entry of existing products into new markets.
Our dedicated team of Regulatory, Quality and Engineering Consultants have extensive experience working with a range of life science businesses. Large or small, you will work with professional, experienced and capable individuals that will consistently deliver a world-class service.
From submitting a marketing authorisation to assisting with market entry with existing products, our team of consultants is perfectly positioned to engineer the bespoke structure, team or process to cope with your requirements.
They talk about us:
“I would certainly recommend Apotech. They offer complete added value. Apotech take the time to investigate how you work as a business and align with your structures in a way that is minimally disruptive. This bespoke, and flexible approach makes for a positive strategic partnership that ultimately leads to successful outcomes.”
Luigi, Head of R&D and Regulatory Affairs
They talk about us:
"Apotech is our UK RP. We knew Apotech as they have been supporting us for regulatory projects in the past. We highly recommend them for their proactive drive to respond to our needs, their technical understanding of the products and for their ability to ensure a smooth dialog between us and UK regulatory bodies."
Antoine Rodrigue – CEO
They talk about us:
"BioCaptiva have been working with Will and his team since we began our regulatory strategy and journey. The advisors that Apotech has assigned to our company have been great and the Apotech team has always been keen to reach out to make sure that we are getting the support and service that we require. I happily endorse Apotech."
Jeremy CEO - BIOCAPTIVA
They talk about us:
"Normally I would expect a bit more discussion on the content of the assignment and what deliverables would be required of me, however in the situation that the end client was in, this was not possible as not even the end client had defined this. However I feel well supported, much more so than in any other project I have been involved in, Apotech is very active in maintaining regular contact and support which I find very helpful."
Terry, Tech Transfer Subject Matter Expert
They talk about us:
"I felt our Regulatory affairs colleagues, spread acrosss Europe, needed to get a better understanding about European and National Food Supplement Regulation. Apotech Trainer, Laure, delivered a taylor made brief, enhancing the European expectation and was able to pinpoint the local national requirements, that would deserve our attention! The information has been well received. Thank you Apotech!"
Anita Dhorajiwala Theramex HQ UK – Associate Director – Regulatory Affairs
They talk about us:
"The bespoke support during the project and the human relationships we managed to set up between the team and the client stakeholders has been a great piece of added value! On top of that Apotech is always looking for feedback to improve themselves, highly appreciated."
Peter, Quality Assurance senior lead
They talk about us:
"I have been involved in a 6-month QMS and CE Marking project. We work as a team and feel very supported in order to deliver in a timely manner, We are working with the best tools and we do have a clear picture of the milestones to achieve . Client project is really sensitive as it is in direct connexion with COVID19. We are glad and confident to work within this environment."
Steven, MD Quality assurance and Regulatory affairs project manager
Our Strength?
Our Bespoke Support
Embracing the best consulting practices (from across Europe):
We always built a strong and loyal client relationship.
We constantly seek for the best suited service offer.
We provide industrial and scientific expertise.
Understanding and implementing the best business processes:
We have a pragmatic approach for each assignment.
We are capable of being extremely responsive thanks to our internal structure.
We stick to a transparent price policy to respect your budget.
Providing the best managerial practices:
Thanks to a 25-year long experience in management from the Army to international consulting firms, we have a unique sense of human management, efficiently combining goal-orientated guidance and close relationships.
You are looking for a career change?
We are continually looking to employ and engage with the best professionals in the industry.