Elan offers our clients an extensive range of drug optimization and development services including formulation development, analytical development, clinical trial manufacturing and scale-up and product registration support. The co-habitation of development and manufacturing capabilities on same sites allows for streamlined scale-up and transfer to commercial scale manufacturing activities.

Development Services

• Formulation and product strategy development
• Analytical method development, materials and product characterization, pilot and commercial stability
• Process development, scale-up and transfer to on-site commercial manufacture
• Phase I clinical study, bioanalytical, PK - managed through in-house staff and a network of preferred CRO’s
• Biopharmaceutics including IV/IVC
• Full project leadership and management  

Project Management
At Elan, we treat each of our customers uniquely. Customers are assigned dedicated project managers who are responsible for their products from start to finish, ensuring they remain on budget and on time.

Development Capabilities

• Pre-formulation Characterization
  • Active, excipient, in-process and finished product characterization. 
• Formulation
  • Feasibility laboratory
  • CGMP area - pilot scale formulation prototype manufacture
  • Experimental design - formulation/process optimization.  

Registration support

• Elan's regulatory department has successfully assisted a number of companies with various applications to the regulatory authorities in the United States, Europe and Japan
• Elan can provide assistance to its clients with the preparation of New Drug Applications and updates, Investigational New Drug Applications, Drug Master files and post-marketing supplements.
• Elan maintains site reference files and authorized access to drug master files as needed.
• Elan's Quality group holds the responsibility of releasing our clients' batch records and undertakes this according to internal standard operating procedures and cGMPs.