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Therapeutics, Inc.

Description: 

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

  • Phase:  1-4

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.

  • Class:  Drugs-Devices-Biologics

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.

 

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.

Acne

Acne Rosacea & Vulgaris

Actinic Keratosis

Aesthetics/Anti-Aging

   -Soft Tissue Fillers

   -Paralytics

   -Sun damage & Other

Alopecia & Hair Disorders

 

Bacterial & Fungal Diseases

      -Tinea Pedis

      -Onychomycosis

Inflammatory Diseases

      -Atopic Dermatitis/Eczema

      -Psoriasis

      -Psoriatic Arthritis

Laser Therapies

Nail Diseases

Photodynamic Therapy

Pigmentation Disorders

Topicals – other

Viral Diseases

      -HSV

      -Zoster

      -Verrucae

Women’s Health

Wound Healing

 

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
  • Medical Monitoring
  • Data Management & Statistics
  • Medical Writing
  • Quality Assurance
  • Regulatory Affairs

 

Services: 

Contact Information: 

Therapeutics, Inc.
9025 Balboa Avenue, Suite 100
San Diego, CA, 92123, USA
Phone : 8585711800152
Fax : 8585711234
Internet : http://www.therapeuticsinc.com/contact/dia.html
Email : bmacy@therapeuticsinc.com
Contact Person : Bryan Macy