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.

Advanced Project Management

Commitment, Flexibility, Transparency

Since organization is equally important to timing, quality and capabilities, Novasep has implemented appropriate project management systems in order to ease communication and consolidate information flow. From start to finish, customers have the same project manager for all steps. The combination of scientific ethics and open communication makes Novasep's project management unique & transparent.

The Novasep team demonstrates passion and commitment towards its partnerships by understanding & focusing on customer needs. Novasep's expertise in Regulatory Affairs provides customers with the most efficient strategy for EU and US DMF filing or CMC drafting. Novasep's Quality Assurance team supports the project from the beginning so that each project incorporates quality by design. Each year, the Novasep teams handle more than 100 projects in early or advanced development phases.

 

Preclinical	Clinical	Commercial
Fast & Pure	Robust & Scalable	Efficient & Economical
Early Stage Services From milligrams to hundreds of grams	Clinical Supply Kilograms	Commercial Quantities Tons/ multi-tons
Non GMP or cGMP synthesis, including purification of preclinical batches for ADME-TOX, stability studies and formulation Synthesis and purification of reference standards, intermediates, analytical standards and metabolites Analytical methods development, stability testing	Chemical route development and optimization cGMP synthesis of APIcandidates for clinical batches Analytical validation and support (impurity characterization, stability testing, quality control support) Process development and process scale-up Process validation & regulatory support (DMFs, CMCs)	cGMP manufacturing in FDAinspected facilities Quality control support Regulatory support Continuous improvement
Experience in scaling-up:
Hazardous chemistry Chiral chemistry	Highly potent synthesis and purification Multi-ton complex, multi-step synthesis	Production scale chromatography Multi-site synthesis