Delim Cosmetics & Pharma s.r.l.

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

Delim’s flexible and dynamic structure, together with its extensive network of consultants, allows it to offer support services for the development of innovative and original medications for topical use, such as semi-solid and ophthalmic products, as well as drugs for systemic administration, including oral formulations (immediate and modified release), vaginal rings and dry powder inhaler systems.

Delim’s principal services, performing under non-GMP conditions, are:

• Pharmaceutical development of Finished Dosage Form
• Analytical studies (set up and validation)
• Design of pharmaceutical products for alternative routes of administration of both known drugs and new chemical entities.
• Patenting support for innovative formulations
• QbD development for oral and topical formulations and medical device from preliminary phases to pharmaceutical development report
• Assistance for cGMP production from tech transfer to optimization of industrial processes

Vision & Mission

The Delim vision is one of end-to-end support for clients through all stages of product development, from early stages to tech transfer, leveraging a Quality by Design (QbD) approach, Design of Experiments (DoE) methodology and deep knowledge of MVA software.

Its mission is to offer a highly advanced and comprehensive suite of B2B services to companies that need innovative technical/scientific support for the development of pharmaceutical products that meet current market and therapeutic needs, in compliance with latest international guidelines. These services include assistance for: patenting, research of active ingredients, prototype development, scale-up of manufacturing methods, production of pilot, validation, and bio batches, clinical trials, regulatory consulting and dossier preparation for product registrations.

Activities & Products

The Delim service and technology portfolio covers a broad range of therapeutic areas and delivery systems.

Formulation development includes five main therapeutic areas:

• Dermatology: topical gels, emulgels, ointments, foams and creams containing corticosteroids, antifungal, anti-inflammatory, antibiotics, disinfectants, hormones, retinoids, anti-acne, antiviral, anesthetics, anticancer;
• Gynecology: vaginal gels and rings, creams, soft gelatin capsules containing hormones and antimycotics;
• Pneumology: dry powder formulations (DPI) for single and multidose inhalation. Among the main products developed we can list: tiotropium bromide, budesonide, budesonide formoterol, fluticasone salmeterol and indacaterol;
• Oncology: FDF intended for oncology therapies (tablets, ODF, and injectable solutions). Among the products developed we can list: Tamoxifen, Flutamide, 5-Fluorouracil, and Everolimus;
• Ophthalmology: FDF both in solution and in microemulsions. Among the products developed we can list: latanoprost and cyclosporine.

Delim also specializes in formulations for Medical Device, covering four main application areas:

• Oral mucosa treatments: development of artificial saliva formulations indicated for the treatment of cancer patients in therapy with radioactive drugs;
• Orthopedics: intra-articular lubricants in sterile solutions and pre-filled syringes;
• Ophthalmology: sterile preservative-free ophthalmic solutions such as eye hydrating drops in single dose and multi dose packages;
• Gynecology: mucoadhesive vaginal lubricating gels with vaginal dispenser, lubricating pessaries and mucoadhesive acidifiers, thermo-responsive gels;
• Aesthetic Medicine: medical device formulations based on use of sodium hyaluronate in its various degrees of polymerization, cross-linking and purity., including fillers and sterile solutions in pre-filled syringes.

Additionally, Delim has developed an innovative and patented technological platform for development of thermo-sensitive products intended for the mucous membranes in buccal (artificial saliva), vaginal (mucoadhesive moisturizing gels), rectal (enema), and bladder (mucoadhesive solutions) applications.

Structure and context

Delim Cosmetics & Pharma was founded in 2008 by owner and CEO Celestino Ronchi in Milan, where it maintains its headquarters, with legal offices in the city center. The company has grown rapidly, securing a number of major contracts with API companies, Contract Manufacturing Organizations (CMOs) and international Clinical Research Organizations (CROs).

In 2020, Delim moved its research and development activities to a new operative site located in the north-eastern Milan suburb of Vimodrone, where it operates 420 m² of laboratories dedicated to formulation development and analytical control.

Delim’s R&D Manager, Dr. Federica Ronchi, has extensive experience in developing immediate- and modified- release oral dosage forms in a fluid bed coater. She is also highly experienced in semi-solid, ophthalmic and inhaled formulations also in terms of technological (rheological, IVRT, PSD, osmolarity, etc.) and chemical-physical characterization.

Its team of pharmaceutical development scientists includes Dr. Davide Ruggeri, a specialist in immediate and controlled-release oral solid doses (OSDs), dispersible oral films (ODFs), and semi-solid forms; Dr. Mattia Ghisolfi, specialized in immediate and controlled-release oral solid doses (OSDs), ophthalmic formulations and semi-solid products; and Dr. Nicoletta Mangano, who has deep experience in the development and validation of analytical methods in liquid chromatography.

Delim’s network of associates and collaborations with academia, including the universities of Brussels, Bologna, Milan, Parma, and Shanghai, allows it to offer an internationally focused suite of services to assist pharmaceutical companies wishing to license their products for the European, North and Latin American markets.

Quality, Regulatory and Standards

Delim offers broad experience in the submission of drug products developed in Quality by Design following the latest international guidelines, such as ICH Q8, Q9, and Q10.

Delim also possesses key expertise in the development and registration of semi-solid pharmaceutical products in compliance with the EMA’s CHMP/QWP/708282/2018 guidelines on topical products equivalence and quality to allow the registration of Q1, Q2, and Q3 topical products with in-vitro release (IVRT) and permeation (IVPT) testing in place of clinical trials.

The company supports its formulation development services with quality control testing and analytical methods development and validation according to ICH Q14 and ICH Q2.

The company is moving towards full ISO 9001 implementation to ensure its quality system.