Scale-up & Development Services

Scale-up & Development Services

Elan Drug Technologies offers our clients an extensive range of drug optimisation and development services including formulation development, analytical development, clinical trial manufacturing and scale-up and product registration support.

We provide our clients full CMC (Chemistry, manufacturing and Controls section) support for their optimised product including handling responses to the relevant regulatory agencies. Our extensive experience in handling the CMC sections for clients provides you with valuable assistance in dealing with regulatory agencies and also determining an appropriate regulatory strategy for your product. 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

  • product concept strategy evaluation
  • formulation development
  • analytical method development, materials and product characterisation, pilot and commercial stability
  • process development, scale-up and transfer to on-site commercial manufacture
  • clinical studies, bioanalytical, PK - managed through in-house staff and a network of preferred CRO’s
  • stability services
  • biopharmaceutics including IV/IVC
  • full project leadership and management



Project Management
At Elan Drug Technologies, 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 characterisation
    • active, excipient, in-process and finished product characterisation.
  • formulation
    • feasibility laboratory
    • cGMP area - pilot scale formulation prototype manufacture
    • experimental design - formulation/process optimisation.


Registration Support

  • Elan Drug Technologies’ regulatory department has successfully assisted a number of companies with various applications to the regulatory authorities in the U.S., Europe and Japan
  • Elan Drug Technologies 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.
  • we maintain site reference files and authorised access to drug master files as needed.
  • our quality group holds the responsibility of releasing our clients' batch records and undertakes this according to internal standard operating procedures and cGMPs.

 

Formulation and Scale-up activities for client-based projects has contributed to more than U.S. $15 billion in in-market sales for these clients. Currently more than 3 million patients take Elan's technology-based products worldwide.

 

Elan Corporation, plc. Registered Office: Treasury Building, Lower Grand Canal Street, Dublin 2, Ireland. Registered in Ireland, Number 30356.