From executive leadership to operations to project management, each member of our team is expert in their role and dedicated to ensuring your program’s quality, consistency, and reliability.
For the majority of our clients we are performing turnkey development activities from concept to regulatory approval. This typically includes but is not limited to program management, nonclinical services, clinical trials from proof of concept to Phase 3 and beyond, regulatory representation and CMC management...from inception to approval.
Each product is unique and we work with each client to customize our services to best fit their needs and requirements. Nonetheless, with each engagement no matter how large or small, we bring a multidiscipline “Full Service Perspective” that increases your ability to achieve or exceed your development objectives.
We encourage you to explore our complete compliment of service offerings in our Product Development, Clinical Development and Regulatory Affairs sections. Our goal is your success!
Therapeutics, Inc. is a specialized, end-to-end dermatology drug development company. With no commercial interest in a product’s end marketing or production, our singular focus is providing the most robust product development to propel your product to its highest potential.
At TI we have deep technical expertise in each aspect of development, with each element seen and reviewed in real-time by industry experts, rather than just “managed” from an administrative perspective. We champion an integrated, holistic approach, envisioning the entire scope while closely studying the crucial details, end effects, and inter-relationships among each step in the process, and ultimately the product lifecycle. This multi-disciplined team approach, honed through multiple FDA approvals, empowers us to navigate the inevitable obstacles with insight, efficiency, and a human touch.
Market evaluation and potential positioning to create the optimal product profile. Includes an integrated development plan that defines the major steps and resources required to bring the product from ideation to market, with end-to-end plan tracking and contingency evaluations.
This results in comprehensive, scalable solutions built upon in-depth market and competitive landscape knowledge.
Bringing the product to life – developing formulation and evaluating formulation characteristics, identifying effective container closure systems, optimizing the manufacturing process, and assessing intellectual property potential.
All ending with best-in-class, turnkey service, with insight from over 50 cumulative years of in-house medical device and pharmaceutical product development experience, and frequent FDA interactions.
Product testing in conformance with FDA requirements to enable clinical studies per US, IND, or other regulatory guidelines, supported by literature review and summary, and non-clinical need definition.
Placement, administrative, and scientific management of studies with qualified preferred vendors, with constant evaluation and migration of results into overall program plan and market position.
Validation of methods and processes required to produce a commercial product which satisfies clinical and market demand, through the technical transfer of development program knowledge.
Providing the experienced insight required to avoid typical knowledge gaps and scaling hurdles, when seeking an optimal fit between product goals and manufacturer capabilities.
Therapeutics, Inc. is The Dermatology CRO. Our focused dedication to dermatology is ideally suited for your dermatology clinical trial activities in drugs or devices. Therapeutics has comprehensive knowledge of dermatologic conditions and diseases and their patient populations. We are flexible and scalable and can manage projects of any size, small to large. Our relationships with our extensive group of expert investigators and research sites are long-standing. And our team possesses a quality that is rare these days: low turnover and continuity. The team that begins a project is the team that completes that project. Let our clinical team be an extension of your in-house team.
Therapeutics, Inc. offers best-in-class Regulatory Affairs support for the dermatology industry. Our team of experts has the experience and know-how to deliver an optimal regulatory strategy for any program, and our extensive interactions with FDA’s Division of Dermatology and Dentistry set us apart from the competition.
We offer complete regulatory consulting, publishing, and lifecycle management services that cover all program and submissions types (505(b)(1), 505(b)(2), combination products, milestone meetings, SPA requests, pediatric study planning, PRO development, product launch, and more). TI will prepare, submit, advise, and coordinate FDA interactions alongside your team or on your behalf (acting as your appointed Regulatory Agent).
From large applications to discipline-focused FDA interactions, let TI help you achieve your regulatory goals.