YOUR PARTNER IN PHARMACEUTICAL DEVELOPMENT
Abstract: Galenica is a Swedish privately owned pharmaceutical company with two business units, one for drug product contract development and one for development and launching of own branded pharmaceutical dermal products. In the contract development unit Galenica supports and guides our partners in their pharmaceutical development programs. We have expertise in pharmaceutical and analytical development as well as in production of Clinical Trial Material (CTM) for Phase I-III. Galenica also manufactures commercially niched products for the market and is authorized and audited by the Swedish Medical Product Agency. Galenica actively develops and launches own pharmaceutical products to the market, utilizing our state-of-the-art expertise in drug formulation, manufacturing and quality control. Our first product on the market, Ovixan(R)/Ovison(R), is an improved prescription-only mometasone cream formulation for the treatment of psoriasis and eczema.
Description: Galenica is a flexible and reliable contract development partner of pharmaceutical projects, and has a proven track record when it comes to quality, knowledge and flexibility as well as keeping timelines. Galenica performs high quality formulation service for our partners in the development of oral, dermal, nasal, rectal, and pulmonary products of small molecules to peptides. Galenica assist our partners to conduct the studies necessary to support all phases of their product development and our staff contribute with their long experience of all types of common dosage forms.
Our experienced development scientists formulate and produce required quantities of clinical trial materials for all stages of our partner's project. From simplified dosage forms in the earliest clinical stages to phase III batches of your final product.
Working to current GMP and ICH guidelines, and pharmacopoeias, Galenica provides pharmaceutical analytical services for a wide variety of development projects. With an extensive range of fully qualified analytical equipment available, as well as comprehensive stability study expertise, we work closely with our partners to assist every stage of the product development process.
Our quality control analytical laboratories ensure compliance to current specifications, from raw materials to finished product. Galenica has quality control systems with strict adherence to GMP regulations.
All pharmaceutical development activities require thorough stability considerations. Our range of storage capabilities are fully compliant with ICH guidelines.
As part of the Galenica pharmaceutical services, we provide regulatory services. We assist our partners through the regulatory hurdles associated with drug development facilitating approval of submissions. In our state-of-the art facility we also have the capacity to provide small scale commercial manufacturing for our partners.
Category: Drug Product
Type: Small Molecules
Contact: Lars Wannerberger ([email protected])