Capability

Capability

ICONOVO has a wide range of competences and skills and have many years of experience from inhalation product development. The main area of expertise is inhalation device development. ICONOVO has also experience from formulation and device development, performance testing, manufacturing of clinical supplies, technology transfer and CMC documentation.

 

ICONOVO has a very comprehensive set of device development expertise and capability including mechanical design, material knowledge, computational modeling, prototyping, verification testing, design for assembly and design for manufacturing etc. ICONOVO has also in-house industrial design expertise and capability. ICONOVO´s industrial designers have been part of designing many inhalation devices.

 

ICONOVO’s most comprehensive development experience and capability is in dry powder inhalation devices. Members of the ICONOVO staff have extensive experience from dry powder inhalation projects from e.g. AstraZeneca. ICONOVO´s staff have been involved in the development of over 13 different dry powder inhaler devices and many different formulation types (micronized, carrier based, engineered) with different API classes.

 

ICONOVO has the facilities and equipment to perform all device and formulation development tasks. In some cases the tasks will be performed in cooperation with suppliers e.g. injection molding, filling and process machine, automated assembly, prototyping etc. ICONOVO has well established relationships with leading suppliers of machinery and has experience from supplier selection and supplier management. ICONOVO staff have been part of supply chain definitions and technology transfer from R&D to commercial manufacturers.

 

ICONOVO has a co-operation agreement with MVIC. MVIC is a full service CRO specialized in inhalation product development and is located in Skåne in the Medicon Valley area. MVIC offers world class expertise within the field of inhalation, covering the whole value chain of drug discovery and development. MVIC has more than 70 inhalation experts and represents over 1000 years of inhalation experience, www.mvic.se. Together with MVIC, ICONOVO can provide a complete service package including formulation development, analytical testing, GMP pilot manufacturing, CMC documentation, regulatory submissions etc.

 

ICONOVO has a fully developed and established quality system. ICONOVO is used to work according to the Design Control requirements in ISO 13485 including Design history, Design change and Risk management. All off ICONOVO´s staff is trained and used to working according to various quality systems. We also have extensive experience of GMP, GLP, FDA and EMEA regulations and ISO standards.