Novasep Synthesis: Exclusive Synthesis Services

Chemical Routes Design

Novasep designs & develops chemical routes for active molecules, for the pharma, biopharma, cosmetic and agrochemical industries.

More about Chemical routes design.

Contract Manufacturing Services

Novasep manufactures active molecules for the pharma, biopharma, cosmetic and agrochemical industries.

These molecules can be Active Pharmaceutical Ingredients (APIs) or advanced intermediates.

Novasep's Exclusive Synthesis services range from Early Stage, Clinical Quantities to Commercial supply.

Early Stage

Early stage services - "Fast and pure"

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

More about Early stage services.

Clinical Quantities

Clinical quantities: API clinical batches under cGMP:

• cGMP synthesis of API candidates
• Regulatory support (DMFs)
• Analytical validation and support (impurity characterization, stability testing, quality control support, sun-tesing...)
• ICH Stability
• Project management (formal and continuous flow of information).

More about Clinical quantities.

Commercial Supply

Commercial supply: Manufacturing of commercial APIs and intermediates at industrial scale:

• cGMP manufacturing in FDA inspected facilities
• Chemical route design
• Process development and process scale-up capabilities
• Quality control support
• Regulatory support
• Multi-ton multi-step synthesis capacities

More about Commercial supply.

Project Management at Novasep

Novasep manages projects in close relationship with its customers. Customer intimacy is one of Novasep's fortes. Our scientists and chemists are closely involved and are used to adapting to the customer's culture doing things the way customers would do internally.

When Novasep develops a Process for customers, all the information regarding the project is transferred to them; even the "chemist's magic touch" is delivered, described so that learning time is shortened and customers do not have to waste it finding this "magic touch". Transparency culture and scientific ethics, combined with an open communication culture is definitely our special way to manage projects. Understanding stakes is the key to bring an understanding of the project for both sides and to lead it to success.

Novasep's teams are committed to go beyond their customers' own expectations. Novasep being a user and provider, we embrace our customers' challenges and stakes as our own, and this provides an environment that encourages innovative ideas. This drives and supports our partners' business objectives. Novasep endeavours to conduct itself with the highest level of integrity and professionalism, transparency and confidentiality. Ethics are an essential part in building long-term working relationships with our customers.