Beyond standards

We support Pharmaceutical, Biotechnology and Medical Devices Manufacturers in the development of their healthcare products.

Alispharm intervenes at every stage of the lifecycle of a health product and accompanies its customers on a wide range of challenges and projects.


Become an expert in your field

"I started my career at Alispharm in 2020 and immediately had the opportunity to become an expert in Quality Control and Analytical Support. Today, I am the mentor of de QC community , which means I help other consultants connect and gain competence in this multidisciplinary field (raw material QC, finished product, stability, method development, method validation, outsourcing management, quality assurance). I am forever grateful for the growth and evolution opportunities Alispharm brought me."

From consultant to member of the Technical Direction

"I joined Alispharm in 2020 and directly worked on the validation of the cleaning and sterilization processes of hip protheses, risk management for spinal protheses and later on I returned to the pharmaceutical industry where I worked in the packaging development department for veterinary vaccines. Two years later, I had the opportunity to be part of the Technical Direction of Alispharm, a group of experts in their field that helps the commercial teams to scope the needs of our clients and also helps the consultants when they encounter challenges in their projects. I feel that I can have a real added value and impact on the company."

From Agro-laboratory Technician to Project Manager

"Alispharm is a human-sized company, with a modern spirit. I followed my instinct and I was right: Alispharm offers many activities and I am very close to my managers who follow up on me regularly!"

From consultant in Quality Assurance to Data Integrity expert

"I am specialized in Quality Assurance, systems oriented. I worked on several projects where I performed Data Integrity analysis for equipments. This means I identified potential deviations and determine whether an equipment needs to changed or not. Today, I am working on the implementation of different requirements, especially in Data Integrity and I organize workshops to train other coworkers of Alispharm on these new systems. I am involed with the internal teams and I recently evolved to Technical Leader. I interview new applicants to verify their technical level."
Become an expert in your field From consultant to member of the Technical Direction From Agro-laboratory Technician to Project Manager From consultant in Quality Assurance to Data Integrity expert

Our top insights

By bringing about corporate change via the strength of people, technology and innovation, Alispharm creates a better working environment.

The most recurring problems in Quality Control

Quality control generates a certain number of quality events such as OOX, deviations and other laboratory investigations. The delay between the opening and the closing of an event can take a certain time due to several factors.

5 questions on Regulatory Affairs in the Medical Device Industry

As an integral part of the healthcare world, the medical device industry must comply with a dedicated regulatory framework to protect the patient and ensure health benefits. The different tasks of the AR department imply a central position in the internal and external interactions of the company. The manufacturing of a DM is organized according to a "Supply Chain". It includes the different departments of the company, whether technical, support or commercial, but also numerous suppliers and subcontractors. Since regulatory requirements apply to the entire manufacturing process, the RAs interact with all the players involved, particularly through regulatory audits.

How to ensure the Validation of a Medical Device

For MD, you need a file that would follow the famous V-cycle and would contain the user requirements, the functional requirements, the risk analysis, the validation plan and the protocols and reports of Installation Qualification, Operational Qualification, Performance Qualification among others. First of all, everything is based on the classification of the medical device in question: I (and special I), IIa, IIb or III, which changes a lot!

Regulatory Affairs in Pharmaceutical Industry

Pharmaceutical and biotechnology regulatory affairs is a complex and ever-changing field, where non-compliance and non-compliance with requirements can result in severe penalties, fines and reputational damage. This poses many challenges to the pharmaceutical industry, which can be described in the different stages of the healthcare product life cycle: Strategic regulatory planning at the development stage […]
Our partners

They trust us

Because of our multidisciplinary experience, we can accompany you on any mission. Whatever the size of your business, industry, or challenge. Your successes are also ours.

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