Pharmaceutical Development and Support

Holitas Limited provides a range of pharmaceutical development and project management services to support generic pharmaceutical development.

Its expert in generic pharmaceutical development and project management has over 30 years industry experience and can manage and facilitate each step of your development project.

As well as providing project management expertise, Holitas can also offer audit and inspection services in respect of all cGMP activities and support in developing data generation and submission strategies.

Project Management

Holitas can provide compete management and interface for outsourced development projects or support existing company staff where additional expertise is required at short notice or for discrete aspects of a project. Holitas staff has expertise in the following areas Sterile nebulised products Sterile ophthalmic products Solid dosage forms (tablets, capsules, soft gels) Metered dose inhalations

Development Strategy

Holitas can provide you with insight and strategy into techniques to maximise the efficiency and extent of in vitro methods to minimise your spend on clinical studies.

Holitas can work with third parties or you own experts to target spending on the most effective combination of in vitro and clinical studies to achieve successful submission and approval of your products.

Nebulized Product /Sterile ophthalmic product development

Holitas can offer extensive experience in the development of sterile nebulized inhaled and ophthalmic products. This expertise includes both solution and suspensions and encompasses both Blow Fill and Seal (BFS) and traditional three component product assemblies. Therapeutic groups previously developed include short and long acting beta-2- receptor agonists, anticholinergic compounds, inhaled steroids, prostaglandins, beta blockers and carbonic anhydrase inhibitors.

Metered Dose inhalations

Holitas staff can provide support in the development of metered dose inhalation products and have experience of products including combined beta-2-receptor agonists and anticholinergic compounds, long acting beta-2-receptor agonists in combination with steroids and single molecule steroid formulatios.

Bioequivalence testing

As part of our service we are able to offer support of outsourced bioequivalence activities including protocol review, CRO inspection and study monitoring.

Solid Dosage Form Development

Holitas staff has a wide range of experience with solid dosage form development including immediate release, modified and sustained release formulations.

Laboratory and Manufacturing Inspection and Audit

Either separately or as part of our project management service, Holitas can offer inspection and audit of laboratory and manufacturing facilities. This includes solid dosage forms, sterile manufacture of inhaled and ophthalmic products using Blow Fill and Seal (BFS) technology and conventional sterile manufacture for ophthalmic products.

Extensive experience with EU and US (FDA) regulatory data generation and submission strategies

Holitas can provide strategic input into study design and alternative methods for satisfying the regulatory requirements of EU and US (FDA) regulatory agencies by the use of in vitro and alternative techniques that optimise your spend on development. Successful approaches have been used in this way in relation to all the dosage forms previously mentioned.

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