At SFI, our Access Services are designed to get our customers into markets around the world. We provide expertise in the following areas;
We provide the scientific evaluation and support our customers’ need. We take the time to understand their product, beginning with analysis of the ingredients, the drug & food composition and a literature search to ensure the preparation is in place to enter the market. At SFI Services we can also prepare and deliver products that are ready for the clinical trial process by ensuring they meet the high standards of our customers’ desired market or clinical setting.
From clinical development plans and tolerability studies to clinical overviews and summaries we can help prove the efficacy, safety and consistency of our customer’s products.
Product Development and Formulation
Our Product Development department helps you build a relevant and compliant dossier to ensure product registration is obtained in the chosen market. Our first-hand experience of registration of products in individual markets around the world means we can help customers through each step of the dossier development and registration journey to ensure they gain the right access and develop a sustainable life cycle for their products.
In the cases where products need further development to meet your business objectives, then our pharmacology assessment and pharmaceutical development capabilities can help to demonstrate the pharmacokinetic profile of your product, further characterise the drug substance of the product and potentially patent these analysis methods to protect your product IP.
Research & Development
For some ideas Research & Development (R&D) is needed to bring a final product to life.
At SFI Services our galenical lab equipment is here to help. We have years of experience in formulating which enables us to assess the feasibility of a product concept including the raw materials, pre-formulation and possible final formulations. This includes services such as development and validation of analytical methods through to stability and photostability studies and the associated reports and regulatory modules.
Our lab scale and pilot scale manufacture capabilities can then be used to produce both small industrial and clinical scale batches of product to support R&D and validation of scale up production.
Our High Pressure Liquid Chromatography (HPLC) & Ultra High Pressure Liquid Chromatography (UHPLC) capacity mean we have the analytical lab equipment to ensure every detail can be tested and then enhanced where required.
We can assess existing research on your product or in the literature to provide guidance on the suitability of claims and help you to develop a strong submission strategy that ensures the documentation needed for both submission and relevant maintenance of the registration is successful.