Early Stage Services:
   Synthesis Combined to Preparative Chromatography.

Custom Synthesis from Milligrams to Kilograms > Fast and Pure

Novasep provides major assistance to the pharmaceutical industry and helps to keep projects on the fast track. Novasep’s Early Stage Services aims at building strong and effective partnerships with our customers by offering fast access to pure compounds, innovation, flexibility, and to support our customer’s needs in preclinical and early clinical phases.

Novasep’s Early Stage team is composed of experienced and knowledgeable chemists, who are familiar with the demands of early stage projects. Novasep has located these chemists on two sites to handle different type of cGMP products, among those highly potent APIs. Both these sites are FDA inspected. Early Stage chemists and project managers interact and communicate directly and regularly with our customers.

Our Services:

• cGMP synthesis and purification of preclinical batches of drug candidates for ADME TOX studies, stability, formulation etc.
• Synthesis and purification of reference compounds, intermediates, analytical standards and metabolites
• Analytical methods development, stability testing including stress stability and regulatory support

Our Added Value:

• Rapid response, quality, purity
• Direct and regular communication between you and our chemists
• Regular reporting system according to your requests
• Ability to synthesize HPAI in a contained environment (OEL 0.1-5 μg/m³)
• Access to our in-house experts in chromatography, membranes, crystallization
• Strict confidentiality and respect of your IP and of the IP generated during our work
• Projects handled with our high standards of safety and environmental concern

Our Expertise:

Combining expertise in both synthesis and purification offers obvious advantages such as being able to select the optimal synthesis stage for purifying the compound. This can add both speed and increased purity to a given project.

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