EXPERTISE & EXPERIENCE

Uniquely specialized cost effective and CDMO Services for added value high potent and oncological oral liquid.

EXPERTISE & EXPERIENCE

State of the art technology and equipment.

EXPERTISE & EXPERIENCE

Strong pharmaceutical experience in the field of added value oral liquids, through the fully customizable philosophy.

TAILOR MADE SERVICES

EXPERTISE & EXPERIENCE

Custom made treatment plan for each patient through dose titration.
Who
We Are

A Fine House S.A is a one of a kind CDMO (Contract Development and Manufacturing Organization) dedicated for added value high potent and oncological products in oral liquid dosage forms. As a team of experts in the development, manufacturing and commercialization of healthcare products, we are able to serve EU, UK and the US market.

Fine House’s high potent products offer the best opportunity to achieve satisfactory uniformity and minimize the risk of exposure to the operator. In addition, these products will allow individualized dosage titration – administration. Palatability studies will also be conducted, and existing pill burden has also been taken into consideration. Patients require drug administration through tube feeding; a liquid dosage form is imperative to overcome shortcomings of currently marketed solid formulations. Dose titration as well as fine dose tuning are particularly important in such treatments. All Fine House’s products will have pediatric/elderly – friendly formulations. Fine House’s approach provides a versatile solution for safe and effective handling of highly potent and other complex API – Scale up is a straightforward contingent upon development that has been conducted appropriately, due to the consistency of liquid handling mechanisms. Fine House is also offering a proven approach to overcome many of the challenges associated with the development, scale-up and commercial manufacturing for those highly potent API (HPAPI), from safer handling to manufacturing more accurately dosed and homogeneous formulations for anticancer products.

A Fine House’s value proposition is unique. The amalgamation of a high experienced team enhanced with high expertise and state of the art facilities, allows A Fine House to have a dedicated facility for development and production of high potent and oncological added value oral liquids.

A Fine House consists of a brand-new high efficiency laboratory dedicated to high potent and oncological oral liquids supported by robust quality systems which ensures the high value of our services to our clients.
our LAB
Our Culture

Mission

afinehouse mission
Our mission is to deliver our unique, cost effective and high quality CDMO services for added value high potent and oncological oral liquids to our clients, in a rapidly changing and demanding healthcare environment. We strive to bring tools to the medical staff in order to help them have the ability of dose titration and most importantly sketch a custom treatment plan for each patient individually.

Vision

afinehouse vision
Our vision is to build strong synergies with the most demanding and creative pharmaceutical companies by providing a wide range of high-quality pharma services including regulatory services, formulation development, clinical development, analytical development, and manufacturing, in order to help patients and doctors to overcome difficulties by making their treatment custom for every single one of them.

Target

afinehouse target
Our goal is to bring high quality, affordable and sustainable added value high potent and oncological oral liquids into the EU, the UK, and around the globe.
What We Do

#AFINEHOUSETEAM

The Experience

The Experience

1

Services

A complete range of development of production of high-quality pharmaceutical products and supporting services are included in our portfolio in order to cover all the needs of our partners.

A Fine House will implement its business model into the extremely promising sector of “high-potent” medicines (in the oncology segment, starting with oral solid forms), where a very strong demand for developments is not currently met. For the time being, there are very few independent R&D labs / CMOs which can address the highly stringent requirements for handling and containment of the HPAPIs and the KPIs of sponsors. Starting imminently, Fine House plans to dedicate a high-potent lab and a small scale (50 L) manufacturing capacity for registration and IMP batches (target granting of the GMP license in Q2/2022). The initial goal is to start the formulation and analytical development of one high-potent anticancer generic in Q1/2022 and submit the dossier for registration in Q2/2023.

We perform feasibility studies including patent search, financial stats, added-value clinical interest, API searching and evaluation of manufacturers. Furthermore, we offer development and registration of pharmaceutical products based on the principles of quality by design.

All products are developed and tested by our experienced and qualified personnel. Quality along with originality are a pre-requisite for all of our products.

Additionally, we provide production services starting from prototypes preparation to scale-up and registration batches followed by full ICH stability evaluation. Pharmacokinetic and bioequivalence studies necessary for the evaluation of the effective in vivo delivery of our products are designed and implemented in collaboration with highly experienced CROs.

After successful completion of the above, we undertake the dossier compilation and offer full support until marketing authorization. Marketed products production is also a service we can guarantee after marketing authorization.

Our aim is to help our partners avoid labyrinth procedures and facilitate them with effective planning and robust collaborations with third parties. This is the reason why our goal is to offer the whole spectrum of services for the development of added-value high potent and oncological products in oral liquid dosage forms.

2
Manufacturing

Capabilities

Soon to be established state of the art GMP manufacturing and testing facility, designed flexibly and customizable for small to medium scale batches of (non-sterile) liquids dosage forms.

3

Consulting

Decades of experience at your disposal!

We can offer tailor made consulting services to help our partners overcome issues and achieve their goals