What we do

Alispharm intervenes at every stage of a health product's life cycle and accompanies its clients on a wide range of challenges and projects with a solid quality and regulatory expertise.

Quality Assurance

We ensure that your medication being manufactured to the patient will provide the desired effect.

Qualification / Validation

We make sure that your systems are meeting regulatory requirements, industry standards and expected performance.

Regulatory Affairs

The Life Sciences industry being the most regulated of all industries, it is key to be compliant to keep your product on the market.

Quality Control

We verify and test your medicine at various stages of production, to ensure every product is of the highest quality.

Industrialization

We help you in the process of applying mechanical, chemical, and electrical sciences to reorganize production with inanimate sources of energy.

We tackle
your challenges

In an environment subject to strong regulatory constraints, we provide you with all the guarantees of success and compliance with the standards in force, while ensuring that we adapt to all regulatory changes.

We provide you with solutions tailored to your requirements, by bringing:

A regular commercial and technical delivery follow-up
A complete and selective recruitment process for our collaborators
A long-term commitment for our customers and collaborators

Our approach

Services & Solutions

Services

We support you by strengthening your teams in:

Quality Assurance
Qualification / Validation
Regulatory Affairs
Quality Control
Industrialization

Our selected collaborators are passionate about health and invested in their projects. They are pharmacist, technicians, engineers, Master 2, etc.

Solutions

With more than 10 years of «business» know-how, AlisPharm differentiates itself thanks to a strong credibility in the «Healthcare» sector.

Our Technical Direction

Structured around more than 20 business expertise, the Technical Direction has to monitor:

The sizing of our projects
The ongoing training of our consultants
The regular technical monitoring of our services
The daily technical support for our consultants on mission

Our Packaged Solutions

Regulatory Affairs for Medical Devices manufacturers
Regulatory Affairs for the Pharmaceutical Industry and Biotechnology
Qualification / Validation for Pharmaceutical Industry, Biotechnology and Medical Devices

Our expertise

Trust the process

The Life Sciences manufacturing processes have precise requirements and guidelines in terms of quality.
We accompany you through every stage of your health product's life cycle.

Research & Development (R&D)

The first stage in the production of a health product is research and development, where scientists and researchers work on identifying and developing new products or improving existing ones. This stage involves identifying unmet medical needs, designing and testing new drugs, medical devices, or other health products, and obtaining regulatory approval for conducting clinical trials.

Clinical Trials

Once the product has been developed, it must undergo testing to ensure safety and efficacy. Clinical trials are the key component of this stage, which involves testing the product in humans in a controlled environment. The clinical trial process typically includes three phases: Phase I, II, and III. During these phases, researchers evaluate the safety and efficacy of the product and collect data to support regulatory approval.

Regulatory Approval

Once the clinical trials are completed, the product must be approved by regulatory bodies, such as the FDA in the United States, before it can be marketed and sold. The regulatory approval process involves reviewing data from clinical trials, evaluating the safety and efficacy of the product, and assessing the risk-benefit ratio.

We can help you with your Regulatory Affairs

Manufacturing

Once the product has received regulatory approval, it can be manufactured on a large scale. This stage involves scaling up production, setting up manufacturing facilities, and establishing quality control measures to ensure consistency and safety.

We help you with Industrial transfers and Commissioning

Distribution and Marketing

The final stage in the production of a health product is distribution and marketing. This stage involves getting the product to market and making it available to patients. This stage may also involve post-marketing surveillance and ongoing monitoring of the safety and efficacy of the product.

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