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.
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Class: Drugs-Devices-Biologics
TI has the development and regulatory expertise to guide drugs, devices and biologics from concept to approval.
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Dosage Route: Topical-Oral-Parenteral
TI manages development programs of all dosage forms in dermatology, and topical forms used for other indications.
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Location: North America and Other
TI routinely conducts studies throughout North America, and at Ex-USA sites for unique indications.
Therapeutic Categories
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.
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Acne
Acne Rosacea & Vulgaris
Actinic Keratosis
Aesthetics/Anti-Aging
-Soft Tissue Fillers
-Paralytics
-Sun damage & Other
Alopecia & Hair Disorders
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Bacterial & Fungal Diseases
-Tinea Pedis
-Onychomycosis
Inflammatory Diseases
-Atopic Dermatitis/Eczema
-Psoriasis
-Psoriatic Arthritis
Laser Therapies
Nail Diseases
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Photodynamic Therapy
Pigmentation Disorders
Topicals – other
Viral Diseases
-HSV
-Zoster
-Verrucae
Women’s Health
Wound Healing
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Full Range of Services for Drug Development
TI provides clients with turn-key and/or customized solutions that include:
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Strategy and Consultation
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Program Planning and Management
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Nonclinical Program Design & Implementation
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Formulation & Manufacturing Support
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Clinical Development Phases 1-4
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Medical Monitoring
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Data Management & Statistics
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Medical Writing
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Quality Assurance
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Regulatory Affairs
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