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    Delim – A specialist in semi-solid generics and innovative topical formulations

    products-servicesDelim Cosmetics & Pharma s.r.l.
    May 9th 2024

    Development of topical products has become a significant growth area for the pharmaceutical industry, including the development of equivalent semi-solid products based on reference listed drugs (RLDs).

    A new generation of gels, emulgels, creams, and ointments have provided more precisely targeted treatment for a variety of common therapeutic needs.

    Applications include corticosteroids, antifungals, anti-inflammatory, hormones, retinoids, anti-acne, antiviral, local anesthetics, and anticancer. With their accessibility and ease of use, topical products provide an array of useful new tools for pharmacies and healthcare providers.

    Innovative and generic formulations

    Delim Cosmetics & Pharma offers a suite of highly advanced B2B services for the development of innovative, and generic pharmaceutical products. One of Delim’s areas of therapeutic specialization is dermatology and the formulation of topical gels, emulgels, ointments, foams and creams containing corticosteroids, antifungal, anti-inflammatory, antibiotics, disinfectants, hormones, retinoids, anti-acne, antiviral, local anesthetics, and anticancer APIs.

    Its in-house specialist expertise takes in development of semi-solid generic formulations that contain the same active and inactive ingredients as the RLD (Q1), in the same dosage form and concentration (Q2), with same physico-chemical characteristics and release rate (Q3), paving the way for accelerated submissions for marketing approval, according to EMA’s CHMP/QWP/708282/2018 guideline.

    Moreover, Delim’s scientists can tailor innovative formulations such as topical creams, gels, and ointments to precisely the characteristics required, employing both new chemical entities (NCE) and well-known APIs.

    Developing the Ideal Topical Drug Product

    At Delim, an early step in the process of developing the ideal topical drug product is the creation of a target product profile (TPP). A typical TPP might include the following characteristics: aesthetically pleasing (appearance, scent, texture), properly preserved, suitable dosage form for the chosen therapeutic indication, regulatory-compliant excipients, adequate tissue penetration, chemical stability of the active pharmaceutical ingredient (API) within the product, physical stability of the product throughout its intended shelf life, development of a manufacturing process that is scalable and results in a robust product.

    Moreover, for the development of topical drug formulations at Delim, these studies are commonly employed: solubility studies of the API, excipient compatibility studies, design and development of prototype formulations, choice of a suitable preservative systems and of the other excipients, accelerated pre-stability study, in vitro release test (IVRT).

    End-to-end support for topical products

    Delim’s service portfolio includes pharmaceutical development of Finished Dosage Form (FDF), design of products for alternative routes of administration, patenting support for innovative formulations, Quality by Design (QbD) and Design of Experiments (DoE) based methodologies for development of topical formulations, supported by set up and validation of analytical studies conducted at its dedicated laboratories in Vimodrone, Milan, along with advice on structuring clinical trials.

    Delim’s laboratories are equipped with leading edge instrumentation and technologies that speed method development and fine-tuning formulations, along with high precision and fully validated product testing for high quality products and accelerated marketing approval. Its team of scientists have deep experience in developing topical products for a broad range of therapeutic applications, using a variety of delivery formats.

    Where requires, Delim can also engineer customized solutions to meet specific needs or challenges, with expertise in optimizing formulations to tailor, for example, drug release rates.

    Delim can also provide assistance for cGMP production from tech transfer to optimization of industrial processes, including sourcing of active ingredients, development of prototypes, production of pilot, validation, and bio batches. Delim’s regulatory specialists can also assist with consultations with regulators and preparation of dossiers for pharmaceutical and cosmeceutical product registrations.


    Click on Delim Cosmetic Formulations for further information.


    Delim is a Contract Research Organization (CRO) that supports the design of generic and innovative pharmaceutical products for topical and systemic administration

    Delim – A specialist in semi-solid generics and innovative topical formulations

    Delim’s formulation scientists can tailor topical creams, gels, and ointments to precisely the characteristics required.

    Contact Delim Cosmetics & Pharma s.r.l.

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