Challenges of Pharmaceutical Regulatory Affairs

The constant evolution of regulations and compliance requirements is always a source of challenges in the pharmaceutical industry, especially within the Pharmaceutical Regulatory Affairs departments.

Thus, when there is a high risk such as stock-outs, batch recalls or marketing stoppages, it is reasonable to be concerned about:

  • Failure to meet deadlines,
  • Files that have not been accepted,
  • Time, means and resources devoted to unsuccessful projects.

That is why we are your trusted advisor and partner!

Galieneo Consulting provides you with the expertise, knowledge and availability you need to:

  • Meet your deadlines,
  • Respond to your specific needs,
  • Guarantee regulatory approvals and adherence to manufacturers’ commitments,
  • Prevent stock-outs and product discontinuation.

We have supported a wide range of pharmaceutical industries, and we are maintaining a trust-based relationship with the authorities. We have gained a good reputation for the quality of our prepared dossiers, efficiency and results.

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They trust us!

acm
aptar
Aspen
Giphar
Guerbet
Innothera
Majorelle
Pyres
Sciencex

We never rest so you can !

Introduction

“All at the service of our obsession of customer satisfaction.

My top priority is customer satisfaction, even before the return on my investment. I am doing everything I can to achieve it!”

Amel Amara

Galieneo Consulting is a French consulting firm founded in 2017 specializing in Pharmaceutical and Cosmetic Regulatory Affairs.

The president Amel Amara, a doctor of pharmacy with a Master’s I in structural chemistry and a Master’s II in analytical development and medicines control, launched Galieneo Consulting after 10 years of experience in the pharmaceutical industry and in consultancy firms. Today, she is assisted by a team of qualified and competent consultants: Industrial pharmacists, doctors of biology and chemical engineers.
Our aim is to satisfy our clients, we provide flexibility and tailor-made services based on your best interests. Galieneo Consulting has proven its ability to scale up and to guarantee the quality of its projects, thanks to the team’s expertise and skills.

As a result, we successfully manage the projects entrusted to us by our customers and ensure compliance with the regulatory requirements of the health authorities. We mainly provide our services to the European market and we are pioneers in the African market.

Our Pharmaceutical Regulatory Affairs service is tailored to your needs

We specialize in health products, mainly medicinal, products. In addition, we intervene in herbal medicines, food supplements and cosmetics.

We offer services in:

  • Research and development,
  • Regulatory advice,
  • Dossiers audit,
  • Writing and submission of dossiers.

Our consultants and experts in pharmaceutical regulatory affairs provide the required scientific and technical support throughout the life cycle of marketing authorization dossiers.

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Our Customers Feedback

ZYDUS France – Rashmin SHAH : Head Europe (Business Development)

« Amel and her team at Galieneo have been providing Regulatory support for our operations in France. Her sound knowledge and rich expertise have been of great help to manage our needs effectively. She was the go-to person for managing the product life cycle as well as new product applications. We will continue to seek her advice for managing the Regulatory Affairs activities for the growth of Zydus business in France. »

FLOW (French League of Writers) – Marie-Odile FAURE : Preclinical and Clinical Development Expert, Scientific and Medical Writer, President

« Always a pleasure to work with Amel. Responsiveness, relevance, and trust that allow us to work together with our clients. »

Nicolas TEISSIER : Président, President of CYTOLNAT company, Managing Director, Responsible Pharmacist at LABODAL

«Working with Mrs. Amara is a real pleasure. Professional, available and rigorous, she has been able to accompany us on complex subjects in an uncertain regulatory situation. I warmly recommend her to everyone. »

GUERBET France – Estelle MORALES : Senior Pharmacist, Director of Pharmaceutical Affairs

“Amel is an invaluable member of our team. She is professional, committed, competent, human and a source of ideas and solutions. The progress made on important and urgent issues has been a real team success, under the impulse and motivation of Amel and her team at Galieneo. My recommendation (and I’ve seen it from consultants) is total. My confidence in Amel is intact and rare.”

PCI – Riadh FATHALLAH : Managing Director

“Thanks to Amel and the entire Galieneo Consulting team for their professionalism, responsiveness and unfailing support in all circumstances. We highly recommend their services and will not hesitate to call on them for our ongoing and future projects.”

1 ter rue de Bonaventure, 78810 Feucherolles, France

Mail : contact@galieneo-consulting.com

Galieneo Consulting is a consulting firm specializing in pharmaceutical and cosmetic regulatory affairs. Based in France, we provide support and guidance to the pharmaceutical and cosmetics industries. We offer pre- and post-MA services for medicinal products, along with support throughout the life cycle of a marketing authorization.

We use our expertise and reactivity to ensure the quality and success of your projects.

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