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Truly ‘tailor-made’ flexible and bespoke solutions

Global Complexity, Simplified Locally

As global industry experts, Apotech helps life sciences organisations around the world streamline processes, mitigate risks and adhere to complex industry regulations. 

We offer a modern and dynamic approach that delivers complete regulatory peace of mind and confidence in your compliance.

Pushing the boundaries of life sciences consulting

After assessing current complexities within international markets and regulatory processes, as well as the gradual integration of intelligent technologies, Apotech was created to meet the unique, ever-changing needs of the life sciences industry. 

From Pharma companies to MedTech manufacturers to in vitro diagnostic (IVD) suppliers, our services have been designed to support organisations throughout the life sciences landscape, allowing cutting-edge medical solutions to reach those who need them most.

Rep Services

Rep Services

MedTech

MedTech

In Vitro Diagnostics

In Vitro Diagnostics

GxP Audits

GxP Audits

Rep Services

Rep Services

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Pharma and Biotech

Apotech offers tailored comprehensive services catering to the Pharmaceutical and Biotech sectors, covering a broad spectrum from generics to cutting-edge biologics such as cell and gene therapies. Our core proficiency lies in deciphering global regulatory standards, whether originating from the US, EU, UK, or other regions worldwide, and seamlessly translating them into compliant solutions for you.

From intricate BLA submissions to specialised onsite GxP audits, and the establishment of biologic manufacturing validation master process, Apotech delivers customised solutions to meet your exact requirements. Our service portfolio includes:

MedTech

Our MedTech consulting services cover all stages, from pre-market preparation to manufacturing and post-market support. Our expertise enables you to achieve regulatory compliance seamlessly throughout your product lifecycle.

With frequent interaction with national competent bodies, and many of our consultants with experience within these organisations, Apotech brings first-hand insights and a personalised approach to support you in all international MedTech requirements to achieve regulatory compliance throughout your product lifecycle. We can provide support in the following areas: 

  • Regulatory Affairs
  • Quality Systems and Compliance
  • Audits
  • Clinical and Post Market
  • Engineering
  • Representative Services

In Vitro Diagnostics

At Apotech, we understand the unique challenges of the IVD industry. Our consulting services are tailored to support you at every stage of your journey, from pre-market planning to post-market surveillance.

With a deep understanding of IVD regulations and frequent engagement with national competent bodies, our team brings unparalleled expertise to help you navigate complex regulatory landscapes and achieve compliance throughout your IVD lifecycle. We can provide support in the following areas: 

  • Regulatory Affairs
  • Quality Systems and Compliance
  • Audits
  • Clinical and Post Market
  • Engineering
  • Representative Services

Audits in Pharma and Biotech

At Apotech, we empower life science companies and manufacturers to meet their regulatory duties and achieve operational excellence via a range of comprehensive auditing services. 

Whether it be ensuring the integrity and quality conduct of your clinical trials, or bolstering the credibility of your data, our team streamline the auditing process to ensure complete regulatory compliance. We cover:

  • GCP
  • GLP/GCLP
  • GVP/GPVP
  • GMP & GDP
  • CSV

Representative Services

Enhance regulatory compliance of your medical devices or in vitro diagnostic (IVD) products by selecting Apotech as your UK Responsible Person, European Union Authorised Representative or Person Responsible for Regulatory Compliance. 

  • UK Responsible Person
  • EU Authorised Representative
  • Person Responsible for Regulatory Compliance
  • Representative Services in Other Countries

Trusted by top-tier teams worldwide

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Have a project in mind_ Let’s work together!
Brian Perry

Working with the Apotech team has been a pleasure. The consultants and team are collaborative, passionate about quality, and show an enthusiasm for their work and their clients that is positive and energizing. Every interaction with the Apotech team has been a delightful experience.

Our global presence spans across the world!

With consultants and teams present in 30 key markets across the world, our global presence is something we’re incredibly proud of. Through the extensive network that we’ve established over the years, we can now offer our full range of consulting services wherever you are based.

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Unveiling Success: Impactful Case Study Highlights

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Globally in-country Regulatory Support

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GxP Audits – Worldwide ​

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Regulatory Strategy  IVDR / FDA

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UKRP & EURP - Representative Services

Our Case Studies offer a compelling glimpse into the services Apotech provides. We showcase real examples of our expertise in action, demonstrating how we partner with clients to overcome challenges, and achieve impressive results.

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Numbers that showcase our success

The story of Apotech started with our two founders: Fabien Pezous and Will Lewis. The rest, as they say, is history. 

Since then, we have grown into a company that offers a global, bespoke approach to each of our services, while remaining strongly committed to our key guiding principles. 

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Projects delivered globally in the last 3 years
Number of clients Apotech has partnered with over the last 3 years
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Percentage of clients who have continued to engage Apotech for additional services
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Number of countries where we have successfully completed projects
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Number of Consultants trusted by Apotech

Meet our talented team

At Apotech, we wouldn’t be able to offer our extensive range of services without the knowledge and commitment that our team has.

Fabien Pezous
Fabien Pezous
Co-founder & CEO
Will Lewis
Will Lewis
Co-founder & Managing Director
Alex Podolski 
Alex Podolski 
Senior Business Manager
Claudia-Rose Mastrobuoni
Claudia-Rose Mastrobuoni
Quality & Regulatory Manager
Thomas Dallyn 
Thomas Dallyn 
Finance & Operations Manager
Ellen Hickey
Ellen Hickey
Audit Business Manager
Jack Sinclair
Jack Sinclair
Business Manager
Elise Pollock
Elise Pollock
Associate Business Manager

Why not join our skilled network of talented professionals?