Therapeutics, Inc. - The Dermatology CRO
Therapeutics, Inc. (TI) is The Dermatology CRO. Our services include: strategy development & planning, program management, manufacturing & formulation support, non-clinical and Phase 1-4 clinical program design and implementation, data management, biostatistical analyses, regulatory affairs, medical writing, and quality assurance.
TI’s team has a strong reputation for quality and innovation among its Pharmaceutical, Biotech, and Device clients of all sizes. We develop the strategy, then formulate and implement the plan. TI’s team has decades of product development experience and numerous product approvals to their credit, and maintains a positive working relationship with the FDA. TI has experience with 505(b)(1) and 505(b)(2), 505(j), BLA, PMA and 510k development programs contributing to numerous FDA registrations of pharmaceutical, biologic and medical device products.
Learn more about TI at: http://www.therapeuticsinc.com/contact/dia.html
Scope of Services
A full service CRO, TI manages Phases 1 – 4 studies including: ph1 (in house), proof-of-concept (POC), pharmacokinetic (PK), dose ranging, pivotal, and post approval.
TI has the development and regulatory expertise to guide drugs, devices and biologics from concept to approval.
Dosage Route: Topical-Oral-Parenteral
TI manages development programs of all dosage forms in dermatology, and topical forms used for other indications.
Location: North America and Other
TI routinely conducts studies throughout North America, and at Ex-USA sites for unique indications.
TI team members have extensive experience in a wide range of dermatology and related indications - both therapeutic and aesthetics. In addition to drugs and biologics, TI is recognized also for device development, especially in the aesthetic arena of injectables and dermal fillers.
Acne Rosacea & Vulgaris
-Soft Tissue Fillers
-Sun damage & Other
Alopecia & Hair Disorders
Bacterial & Fungal Diseases
Topicals – other
Full Range of Services for Drug Development
TI provides clients with turn-key and/or customized solutions that include:
Strategy and Consultation
Program Planning and Management
Nonclinical Program Design & Implementation
Formulation & Manufacturing Support
Clinical Development Phases 1-4
Data Management & Statistics