Therapeutics
Analyze: Therapeutics is a San Diego-based company specializing in dermatology drug development with over 20 years of experience. They offer comprehensive solutions for non-clinical, clinical, and regulatory challenges, including managing Phase 1-4 studies and providing regulatory consulting and lifecycle management services.
Company Overview
Therapeutics is a San Diego-based company specializing in dermatology drug development. With over 20 years of experience, the company focuses exclusively on the dermatology sector, offering comprehensive solutions for drug and device development. Therapeutics provides integrated, turnkey services spanning non-clinical, clinical, and regulatory stages, guiding products from concept through FDA approvals.
Dermatology Expertise
Therapeutics has extensive knowledge of dermatologic conditions and diseases, deeply understanding the needs of patient populations. The company's specialized focus extends across various dermatology indications such as acne, anti-aging, atopic dermatitis, bacterial skin infections, fungal diseases, hair disorders, hyperhidrosis, nail diseases, neoplasm, pain/dermal analgesia, pigmentation disorders, photodynamic therapies, psoriasis, rare and orphan diseases, subcutaneous fat reduction, viral diseases, and wound healing.
Clinical Development Services
Therapeutics conducts Phase 1-4 dermatology studies with a dedicated focus on clinical trials for dermatology drugs and devices. The company has managed over 200 dermatology trials and has long-standing relationships with expert investigators and research sites. Therapeutics' clinical development services ensure thorough and accurate study execution, catering to the specific requirements of dermatology research.
Regulatory Affairs and Consulting
Therapeutics offers a broad spectrum of regulatory affairs services including regulatory consulting, publishing, and lifecycle management. The company provides regulatory intelligence and strategy, FDA representation, regulatory management, and regulatory operations and publishing. With a strong background in navigating regulatory hurdles, Therapeutics helps clients achieve compliance and successful product approvals.
Product Development and Strategy
Therapeutics provides end-to-end product development services, covering product strategy and detailed planning, product realization (CMC), safety testing studies, and commercial production. The company's comprehensive suite of services supports the entire drug development lifecycle, from initial concept through to FDA approvals, ensuring that all aspects of product development are meticulously managed.