Shertech can provide solutions to common clinical supply challenges, such as those found in packaging, release, labeling, and supply management. These solutions integrate into the development and formulation phases of a wide range of end products such as:
Clinical Drug Development Process
For drugs that are still in the developmental phase, we offer a broad range of services to facilitate the development process. Our formulation development services include:
- Drug discovery
- Development and reformations from phase I through phase IV
- Analysis of product and process characteristics such as blending time, density in bulk, uniformity of blended products, and flow
- Packaging development, especially those products with special packaging requirements
- Delivery and warehousing of developed products
Supplies for Every Clinical Trial Stage
The Shertech team is dedicated to leading the way in every stage of clinical trials and providing solutions to the various challenges that arise.
During phase I of the development process, pharmacokinetic parameter and tolerance evaluations take place in a trial group comprised of 100 people or less. The clinical trials conducted by Shertech at this level include initial single-dose studies, dose escalation, and short-term, repeated-dose studies in healthy volunteers.
Phase II involves small-scale trials comprising of between 100 and 500 patients. The trial goal is to determine the product’s preliminary efficacy and side effect profile. In addition to meeting these objectives, Shertech includes safety and clinical pharmacological studies for a fully developed profile.
In phase III, large-scale clinical trials involving several hundred to several thousand patients are the objective of drug analysis. While working to provide more comprehensive and definitive data related to efficacy and side effects, Shertech also assists our clients in complying with FDA standards to introduce the drug into the market and completing the require licensing applications.
Stage IV trials, also referred to as post-marketing surveillance trials, are conducted after a product receives FDA approval for consumer distribution. Shertech assists their clients with the various aspects of this phase of development, including:
- Packaging and labeling
- Storage and distribution
- Supply chain management
- Sourcing of comparator drug and ancillary supplies
- Controlled drug services
- Management of inventory
Short Run Pharmaceutical Manufacturing
Short run manufacturing is used for small to moderate volume production runs. It allows for greater flexibility and shorter lead times, especially when compared to traditional, higher volume runs. Additionally, customers that purchase short run products benefit from the lower cost of newly developed drugs, reduced storage costs, and minimized need to destroy obsolete products.
In light of the advantages afforded by short run manufacturing, Shertech offers capabilities for short production runs of clinical products according to the specifications of our clients, such as new product testing, value sets, or seasonal packaging.
Private-label pharmaceutical manufacturing helps stores and small companies create pharmaceutical, nutritional, and cosmetic products that can compete with national brands. Shertech designs a wide range of generic and store-brand products that can compete on a national level.
Contact Shertech Manufacturing, LLC Today
At Shertech Manufacturing, LLC, our expertise, full service capabilities, and capacity to house large volumes of raw materials and supplies uniquely positions us as a cost-effective leader in the clinical drug development market. Our 10,000 plus square foot facility offers both cGMP manufacturing capabilities and climate controlled warehousing of products and raw materials. Its location also expedites the logistics of resupply and delivery services.
Contact us today to learn more about how our solutions can assist in your drug development and clinical supplies applications.