Galieneo Consulting, to meet your specific needs in terms of pharmaceutical regulation

Amel AMARA, founder

Amel AMARA is a doctor of industrial pharmacy with a Master’s I in structural chemistry and a Master’s II in analytical development and medicines control.

Amel has extensive experience in pharmaceutical regulation:

As a research and development specialist in the pharmaceutical development departments of Guerbet and Biogaran laboratories,
As a consultant in regulatory and pharmaceutical affairs in consulting firms.

She offers her technical expertise and advice on pharmaceutical regulation to professionals in the healthcare industry. In particular, she manages pharmaceutical and technical projects, as well as designing and writing modules 2.3 and 3 of marketing authorization dossiers for medicinal products and pharmaceutical variations.

In addition, Amel conducts audits of pharmaceutical dossiers and is involved in designing and compiling information dossiers for cosmetic products, as well as declaring food supplement dossiers to the health authorities.

Amel AMARA is a doctor of industrial pharmacy with a Master’s I in structural chemistry and a Master’s II in analytical development and medicines control.

Amel has extensive experience in pharmaceutical regulation:

As a research and development specialist in the pharmaceutical development departments of Guerbet and Biogaran laboratories,
As a consultant in regulatory and pharmaceutical affairs in consulting firms.

Galieneo Consulting

Amel Amara with solid experience in pharmaceutical regulation and keen awareness of the continuous evolution of healthcare product legislation, founded Galieneo Consulting in 2017, to provide support to pharmaceutical manufacturers.

Galieneo Consulting was born from the aspiration to merge expertise and responsiveness within a compact organization closely attuned to the needs of its clients. Our firm offers holistic solutions to assist the healthcare industry in meeting regulatory requirements and respecting deadlines throughout the product life cycle.

Ensuring compliance of regulatory dossiers for medicinal products entails adaptation to requirements and to the constant evolution of the state of the art. Industries often need the support of experts with in-depth knowledge of specific regulations and experience in collaborating with health authorities.

Aware of the significant challenges of the pharmaceutical industry’s quality and regulatory environment, our consultants and experts are available to explore with customers the most appropriate solutions and directions for the projects entrusted to them at the earliest convenience.

We assist healthcare industries in:

Maintaining their dossiers in line with regulatory changes throughout the life cycle of medicinal products,
Developing their products in compliance with specific regulatory requirements to enter new markets,
Designing and creating new dossiers for new chemical entities of therapeutic interest.

Learn more

The team

Our team of qualified and skilled experts is formed by:

Industrial Phamarcists

PhD in Biology

Chemical Engineers

Our services are tailored to your needs

Galieneo Consulting is the quiet force in your team dedicated to meet your specific needs, mainly in terms of:

Research and development in partnership with qualified collaborators

Regulatory advice

Drafting and submission of dossiers

Dossiers audit

The pharmaceutical dossiers of medicinal products are our main area of expertise in pharmaceutical regulation. We intervene throughout the life cycle of marketing authorization (MA) dossiers, ensuring their regulatory and pharmaceutical compliance.

Additionally, we provide project support in the fields of registered traditional medicines and food supplements.

Meeting your needs is at the core of our approach

Our tailor-made approach is based on 4 essential pillars:

LISTENING TO YOUR NEEDS

ANALYSIS AND ADVICES

EFFECTIVE IMPLEMENTATION

FOLLOW UP AND SUPPORT

Galieneo Consulting presents a tailor-made work process that meets the client’s specific needs in terms of pharmaceutical regulation.

Therefore, our work methodology is based on a thorough analysis of projects and situations, adaptation of the solution, and responsiveness in implementation. We support our clients throughout the stages of their projects and ensure the quality of the output and compliance with the requirements set by health authorities.

Our values

Customer satisfaction

Customer satisfaction is our ultimate goal, which has helped us to build a positive reputation in the industry. Our firm provides high-quality services that meet customized needs in a timely, efficient and transparent manner.

Dossiers quality

Thanks to our expertise and teamwork, we attach the utmost importance to controlling and guaranteeing the quality of the output. We implement rigorous document management, version control and error verification processes to guarantee the best results.

Flexibility and adaptation

Scalability

We efficiently manage our resources, personnel, and the growing number of clients and projects entrusted to us to maintain a high level of quality and consistency in our work. We position ourselves for long-term success and confident, sustainable collaboration.

Our corporate culture

Organization

Conscientious work

Quality

Commitment

Responsiveness