R&D SOLUTIONS

PRODUCT DEVELOPMENT

When you’re engineering a pharmaceutical delivery system of the future,

Product development

When you’re engineering a pharmaceutical delivery system of the future, innovation drives everything you do. At Ritedose each project begins with product development, where our multidisciplinary approach results in innovative delivery systems for sterile and non-sterile liquid pharmaceuticals.

Packaging Solutions

Due to inherent chemical stability issues, many pharmaceutical products need special protection during packaging. Our team is developing innovative packaging for drugs, which are prone to oxidation and hydrolysis. An example of this packaging is evident in our SL-Lock product. The packaging is a needle-free injectable device that allows sterile delivery of a drug directly into a syringe.

Innovation in products

Our RiteDose™ spoon demonstrates our use of Research and Development to answer an unmet medical need. We developed this unique delivery system to deliver a precise dose of oral liquid, solving the common problems of under and over dosing using a conventional spoon.

New Technology for BFS

We use our expertise in BFS technology to develop delivery systems that improve the medication experience. Our team is currently adapting BFS technology for a variety of liquid products with a wide range of viscosities.

REGULATORY

RESPONSIVE RETINA READY DESIGN WITH UNLIMITED LAYOUT OPTIONS.

FDA submission
Whether submitting a new or an abbreviated drug application, TRC can help you with compiling the submission as well as registration with the FDA or DEA if required.

Registration management
TRC currently manages multiple NDA, ANDA, and 510K registrations. Our team of experts offers full service management of the regulatory registration including Annual Reports, Annual Product Reviews, Registration Amendments and Updates.

DEA registration
Our facility is approved for the manufacturing and handling of up to Schedule II substances. We have a staff of experts to manage the registration, quota, and material handling requirements.



reguletory

PROCESS DEVELOPMENT

TRC offers full manufacturing process development services, including pilot studies and clinical batches, all of which are scalable for commercial batch production.

Product formulation

  • • Batch sizes from 200 to 1800 liters
  • • Compounding for true solutions, suspensions and emulsions

Product Filling

  • • Filling of liquid pharmaceuticals utilizing BFS technology in dedicated fill suites serviced by independent air handling systems
  • • All environmental parameters are monitored continuously by a validated Building Management System
  • • Viable monitoring of the classified environments validated for aseptic pharmaceutical manufacturing

Finished Packaging

At TRC we recognize that product volumes during its life cycle require varying capacity requirements. To address this need, we have semi-automated, highly flexible packaging processes for registration of small batches to highly automated, high speed packaging equipment for high volume products.

Analytical Development

TRC maintains fully functional chemistry and microbiology laboratories capable of development, transfer, and validation of analytical test methods in support of product formulation, extractable and leachable studies, stability studies, validation studies, and clinical supplies.



BUSINESS DEVELOPMENT

At TRC we take a very straightforward approach to establishing agreements with our clients.

First we will initiate a two way nondisclosure agreement so that we can establish a confidential dialogue about your product and process.

Once we have the nondisclosure in place, we provide you with a comprehensive product information gathering form to help us better understand what your needs are and how we can best meet them.

Upon review of the product information with our project review team, we will move to gain approval to proceed from our senior management team.

As soon as we have approval to move forward with your project, we will start the process of establishing a development agreement. This process typically takes place in parallel with a more detailed project definition process that will involve members of our development as well as quality and operation groups. The goal of this step by step process is to develop a comprehensive, cost effective and efficient project plan and development agreement that meets the needs of both parties.

We also have a well defined process to develop and negotiate short term as well as long term commercial supply agreements.

Please contact our Business Development department today to discuss how TRC can help you develop and deliver your product.