Apotech Consulting: Helping Life Sciences Companies Bring Safer, Compliant, and Innovative Products to Market Faster

The Silicon Review

Life sciences consulting organizations help pharmaceutical, biotech, MedTech, and IVD companies manage the regulatory environment, maintain quality standards, and ensure product safety and compliance. Organizations risk expensive delays, recalls, non-compliance with regulations, and decreased patient safety in the absence of such guidelines. Apotech Consulting contributes significantly to the industry by offering specialist engineering, quality, auditing, and regulatory services in more than 30 countries. Life sciences companies may fulfill international compliance standards, accelerate product development, and more successfully and reliably launch safe, cutting-edge products to the market thanks to Apotech's vast experience and customer-focused methodology.

About Apotech Consulting

Apotech is a global industry expert that assists life sciences organizations worldwide with risk mitigation, process optimization, and compliance with intricate industry laws. They provide a contemporary and innovative method that gives you total regulatory comfort and assurance regarding your compliance.

The two founders of Apotech, Will Lewis and Fabien Pezous, had the same vision for the company: to establish a consulting business that would be able to meet the specific, dynamic demands of the life sciences sector. They had almost twenty years of combined life sciences consulting expertise, and they had the same goal in mind: to establish a life sciences consulting business that aligned with their shared perceptions and understanding of the field.

Expert Solutions for Life Sciences

Pharma and Biotech Services

Apotech's pharmaceutical and biotech services are intended to help you navigate the complicated world of biologics and medication compliance, and market access. It has been observed that the company offers a variety of auditing services that enable manufacturers and life sciences companies to attain operational excellence. Additionally, it provides both on-site and remote audits to help the pharmaceutical and biotechnology sectors meet the highest standards for quality and safety. Strong quality systems must be established and maintained to ensure patient safety and the integrity of pharmaceutical and biotech products. They understand how important it is to maintain the highest standards of quality, efficiency, and compliance in your operations. Their knowledgeable staff is dedicated to assisting companies in developing robust QMS solutions that will ensure regulatory compliance, streamline operations, and enhance overall performance.

In Vitro Diagnostic (IVD) services

Apotech's IVD services are painstakingly crafted to assist you as you navigate the complex terrain of market access, quality control, and regulatory compliance. Successfully navigating the regulatory environment is essential for your IVD products. Their knowledgeable staff offers professional advice and assistance with FDA filings, Developed Tests, CE Marking, UKCA Marking, and international regulatory needs communication with regulatory agencies and national competent authorities, such as Notified and Approved Bodies. The organizational structure, protocols, processes, and resources used by manufacturers to guarantee that their IVD products continuously satisfy quality standards, specifications, and regulatory requirements over the course of the product lifetime are collectively referred to as quality compliance for IVD devices. Your quality management system (QMS) is strategically examined through internal audits in comparison to pertinent standards like ISO 13485.

MedTech Services

MedTech services are intended to assist you as you navigate the intricate world of medical device development, compliance, and market accessibility. They provide a variety of FDA compliance and regulatory services that are especially targeted at establishing confidence in your products, obtaining successful submissions, and fostering solid connections with US regulators, all supported by the experience of their US consulting team. Their team, which is expert in getting gadgets ready for the US market, can assist you in classifying your device and deciding what kind of premarket submission you need. Apotech can help you navigate the process because they are aware of the intricacies involved in medical device regulatory compliance in the UK. They will assume certain duties as your UKRP to guarantee that your products fulfill the strictest requirements stipulated by the MHRA.

Your Trusted Partner in Compliance

Across the Pharma, Biotech, MedTech, and IVD sectors, Apotech Consulting is transforming the life sciences sector by streamlining regulatory compliance, improving quality processes, and guaranteeing product safety. By lowering the possibility of expensive delays, recalls, and fines from the government, their professional services assist businesses in launching innovations more quickly and consistently. Apotech was founded by Fabien Pezous and Will Lewis, and its client-focused strategy and global presence give life sciences firms the assurance and assistance they need to comply with intricate standards and maximize performance around the globe.

Fabien Pezous | Co-Founder & CEO

Based in Paris, France, Fabien has over twenty years of managerial experience and has worked as a consultant in the life sciences sector for ten years. Fabien, who has a strong interest in delivery models, client relationships, and innovation, is constantly searching for innovative methods to support Apotech's customers by growing the company's offerings and improving its current services. His broad multicultural and global expertise has led him to be involved in the company's international expansion, including the successful certification of our UKRP and EUAR accreditations. Fabien is in charge of creating Apotech's strategic vision as a co-founder.