The Life Sciences Innovative Manufacturing Fund (LSIMF)

Eligibility recorded

Your company To be eligible to apply for the fund, your company must be: A UK registered company, or a UK registered establishment UK establishments must also have at least one UK registered company in their group structure A wholly private sector business A product developer, contract development manufacturing organisation, or a generics manufacturer. Applicants must also be able to provide two years of audited accounts for the applicant company (and/or if applicable, parent entity). If this is not available – for example because the company is not required by Companies House to submit audited accounts – we will ask for demonstration that the remaining funding required for the project to go ahead is available. You may be also asked for evidence that your company (or if applicable, parent entity) has a track record of successfully manufacturing medicines or medical devices in the UK or abroad, or that you have successfully developed a product intended for commercial scale-up. Your project To be eligible for the fund, your project must: Have a total eligible cost of at least £8 million . Eligible costs include capital, R&D and skills/training expenditure. This should exclude operational expenditure. Be located in the UK Be primarily a capital investment Be a single company investment, or a joint investment between multiple entities within the same company group structure (as opposed to forming a partnership between independent companies or other types of organisations) Require only the amount of grant requested to proceed. For example, without the specific amount of funding you are requesting your project wouldn’t go ahead or go ahead at a smaller scale, go ahead overseas or would be significantly delayed (3 years or more) Your project must be a manufacturing project for the manufacture of: Human medicines (this includes both the manufacture of active pharmaceutical ingredients (API) / drug substance and finished product / drug product) Medical diagnostics – for both disease identification and monitoring MedTech products – all types of medical devices related to human health. The fund is open to applications for MHRA-licenced medicines, medical and diagnostic devices registered with the MHRA, and products in development where approval to market or manufacture the medicine or device in the UK is intended to be sought for commercial scale-up, for example a manufacturing project for clinical trials or investigational studies. Manufacturing facilities are required to work to Good Manufacturing Practice (GMP) and the facility be intended to support clinical and/or commercial manufacture of API or drug product. Manufacturers of medicinal diagnostics and medical devices must confirm that their device meets or intends to meet the requirements of the Medical Devices Regulations 2002. Projects relating to the following are not eligible for funding from LSIMF: Veterinary medicine Herbal medicines Nutritional supplements or vitamins Raw ingredients (e.g solvents, buffers and cleaning agents) The production of single-use consumables that are not integrated into a larger product (e.g manufacturing syringes independently from diagnostic kits) Secondary packaging for products or materials (e.g package inserts, labelling and boxes).

Recorded geography: United Kingdom

Applicant types