Our mission
To provide availability, expertise and reliability to our customers, in Italy and abroad.
Our sales force is present in Italian hospitals, in care facilities and in pharmacies. Our technicians and our laboratories are constantly engaged in Research & Development, in collaboration with the research centres of the Universities of Siena and Florence and of US universities.
Our export sales office ships products all over the world, assisting customers both from a regulatory standpoint and in the preparation of the dossier, including in foreign languages.
The company is structured in compliance with GMP standards, for both human and veterinary medicinal products. Having contacts with customers from all over the world, the quality system integrates GMP with the WHO, PIC/S and ICH regulations. It is also authorised for the manufacture of medical devices (CE).
1 · Research & Development
The evolution of formulation research at Galenica Senese. Since 2022 the company has undergone a strategic turning point, setting up a new and modern in-house Formulation Research and Development Laboratory. This structure is the beating heart of Galenica Senese's scientific innovation, complementing our historic strength in the production of infusion and injectable medicines with a constant drive towards emerging markets and high-added-value technologies.
Under the guidance of our R&D management, the laboratory's work has focused on broadening the research space, integrating traditional pharmaceutical development with the exploration of new formulation frontiers.
Our areas of research
Advanced delivery systems (liposomes)
Study, design and development of liposome-based technologies to improve the stability, delivery and bioavailability of active ingredients.
High-tech aesthetic medicine and cosmetics
Formulation of cutting-edge solutions for medical aesthetics and cosmetic dermatology, combining pharmaceutical rigour and innovation.
Next-generation nutraceuticals
Research and development of food supplements and complex functional formulations to meet modern health and prevention needs.
Optimisation of pharmaceutical formulations
Ongoing technological refinement, formulation restyling and improved stability of existing products, optimising technology transfer from laboratory scale to industrial production.
2 · Analytical Services Excellence
Advanced GMP analytical services supporting the entire pharmaceutical product lifecycle.
Our GMP Quality Control facilities comprise two dedicated and separate laboratories — one specialising in chemical and physico-chemical testing and the other in microbiological testing — providing comprehensive analytical solutions for raw materials, intermediates and finished pharmaceutical products. From early-stage development to commercial manufacturing, we support our customers throughout every phase of the product lifecycle with reliable, science-driven laboratory services.
Our laboratories have successfully passed inspections by AIFA, the U.S. FDA, the Italian Ministry of Health, the Istituto Superiore di Sanità, and international pharmaceutical companies. Backed by scientific expertise, regulatory excellence, and advanced analytical technologies, we provide reliable, accurate, and timely analytical results that meet the highest international standards. All analytical activities are performed in full compliance with GMP requirements, generating high-quality data to support product release, quality documentation, and regulatory submissions.
Our capabilities
- Release and quality control testing of raw materials, intermediates and finished pharmaceutical products in accordance with the major international pharmacopoeias;
- chemical, physico-chemical and microbiological testing performed under GMP;
- analytical method development, optimisation, transfer and validation in accordance with ICH guidelines;
- stability studies conducted in accordance with ICH guidelines, supported by qualified climatic chambers;
- comprehensive microbiological testing, including sterility testing, microbial enumeration, microbial identification by MALDI-TOF MS and bacterial endotoxin testing;
- tailored analytical solutions designed to meet customer-specific requirements, from routine quality control to complex analytical challenges.
A trusted analytical partner
Our experienced team of analytical scientists works in close partnership with pharmaceutical companies, supporting projects from early-stage development through routine GMP quality control and lifecycle management. Whether performing routine release testing, developing and validating analytical methods, transferring analytical procedures or conducting long-term stability studies, we provide reliable data, robust scientific expertise and responsive technical support.
By combining technical excellence, regulatory knowledge and operational flexibility, we deliver tailored analytical solutions that help our customers ensure compliance, accelerate development and consistently bring high-quality pharmaceutical products to market with confidence.
3 · Regulatory Affairs
The Regulatory Affairs department follows the dossier from technical documentation through to registration, supporting customers in foreign markets as well.
Standards and collaborations
Compliance
GMP human and veterinary use · WHO · PIC/S · ICH
Research & Development
In-house laboratory · Universities of Siena and Florence and US institutions
Regulatory Affairs
Dossiers and registrations, including foreign markets
Medical devices
CE authorisation