Certara is the global leader in advancing modern, efficient drug development. We provide proven modeling & simulation, regulatory science, and scientific value assessment software and services to help our clients reduce clinical trial burden, accelerate regulatory approval and increase patient access to medicines. Our unique Simcyp dermal model has recently been accepted by the FDA to demonstrate virtual bioequivalence in lieu of a clinical trial, thus reducing cost and speed, while also providing additional insight into a drug’s performance.
MedPharm is the world leading specialist pharmaceutical development company, committed to the creation and development of bespoke topical and transdermal formulations for application to the skin, nail, mucous membranes, eye, nose and lung. Alongside developing its own patented dermal drug delivery technologies, MedPharm uses its experience to support customers through regulatory approval previously resulting in biowaivers for generic submissions from regulatory authorities and marketing authorisations for over 60 products in the US and Europe.
Tergus is a full-service topical pharmaceutical research, development, testing and manufacturing company. The company is an industry leader for more than 20 years with a state-of-the-art facility in Durham, North Carolina. The company has a long and stellar reputation for delivering quality and results for clients from formulation through manufacturing, which is why people say, “Think Topical. Think Tergus.”
San Diego based, Therapeutics, Inc., The Dermatology CRO was founded in 1997. Approximately 90% of our activities are focused on developing dermatology products. TI is the only dermatology-focused CRO that provides all services required to move a product concept through non-clinical and clinical stages to FDA approval. During the last 5 years: TI managed >12,000 subjects in >80 clinical studies and filed 18 INDs and IDEs in a variety of drug, device and biologic programs.
CPL is a leading contract development and manufacturing organization providing product development and commercial manufacturing of non-sterile liquid and semisolid pharmaceutical and regulated OTC products. Our facilities are registered by FDA and Health Canada and maintain an outstanding record of regulatory compliance. CPL is a reputable contract manufacturer known to provide high quality product with exceptional service. By offering a full-spectrum partnership – from development to commercial production – CPL creates strategic, long-term relationships with our customers.
Groupe PARIMA is a CDMO specialized in liquid, suspension, semi-solid and metered-dose-spray dosage forms. We have the expertise to support the full lifecycle of your product from initial development and clinical lots to commercial manufacturing. With presence in over 30 countries, we can serve as your gateway to overseas markets. In our US-FDA and Health Canada inspected facility, we currently manufacture drug products for the US, Canadian, European, Asian and Latin American markets
Dow Development Lab’s core expertise is in the design, development and manufacture of topical drug products for dermatology. The formulation, analytical, production, quality, and clinical labeling groups have decades of experience moving products quickly toward regulatory approval. Always with the patient in mind, products are designed to be disease-compatible and cosmetically elegant. Dow Development Labs works seamlessly with its parent company Symbio, a specialty clinical CRO, to rapidly advance client dermatological programs through all stages of clinical development.
DPT, a Mylan company, is a leading contract development and manufacturing organization, recognized for its excellence in semi-solid and liquid dosage forms. Backed by a team of approximately 1,000 employees in San Antonio, Texas, DPT has unmatched experience, resources and capacity to efficiently serve your pharmaceutical development and manufacturing needs – no matter the scope. From concept to commercialization, DPT remains committed to exceeding expectations for quality and service.
proDERM is an internationally renowned CRO with a specialized focus on studies relating to skin and mucous membranes, offering customized and innovative solutions to Sponsors worldwide, running studies in our dedicated clinic and in our growing network of qualified sites in Germany. proDERM has established an excellent reputation as a high-quality provider of trial services, on the basis of an outstanding technical set-up and expertise, including Confocal Microscopy, Raman Spectroscopy and many state-of-the art skin measuring devices.
Synteract is an innovative CRO providing full-service, Phase I-IV services to biopharma companies in bringing new medicines to market. We align our operational excellence, therapeutic expertise and the right technology to support each client’s clinical development needs. Over its nearly 30-year history, Synteract’s leadership has been proven in the core development areas of dermatology, oncology, neuro-degenerative disorders, rare/orphan disease, and pediatrics, and has contributed to more than 240 product approvals in these and additional therapeutic areas.
QuantifiCare is an Imaging CRO specialized in the management and analysis of 2D/3D digital images in Phase I-IV multicenter trials. With over 18 years of experience in clinical research and medical image processing, QuantifiCare has developed a strong expertise across the fields of dermatology, aesthetics, wound care and oncology. The company operates internationally from its offices in the USA, Europe, South America and Asia.
Bioskin is a leading CRO with unique understanding and capabilities for both early and late phase dermatological clinical trials. Recognized by global companies as a valuable partner in studies for drugs, medical devices, food supplements and advanced cosmetics since 1992, bioskin offers early phase safety and Proof-of-Concept studies, vasoconstrictor assays according to FDA guideline, global Phase II – IV trials for NCEs, new formulations with known actives as well as consulting in the field of dermatology.