The difference between success and failure to outsource development or manufacturing services is often found in the selection of business partner (BP). At ULSA TECH we have the tools and experience required to provide these services. We adapt to the specific needs and objectives of the client, and we seek to integrate into their corporate culture and customer processes.
If you are looking to reduce operating costs, increase capacity, accelerate the speed of your developments, flexibility, efficiency or simply outsource some of your processes, we have an extensive menu of services, from the selection and evaluation of raw materials and APIs, to manufacturing, storage and distribution at industrial level.
With first class installations and high level processes, our main focus is on patient safety and convenience.
Raw Materials Development
We have an expert group of scientists, regulatory affairs and legal team that provides the service for the evaluation and selection of critical raw materials and excipients, considering:
•Evaluation of Drug Master File (DMF)
•Patent evaluation (molecules, formulas, processes)
•Regulatory requirements of the manufacturing source
Extensive experience and access to the latest technological capabilities are essential for the development and manufacture of increasingly complex medicines. At ULSA TECH you will work directly with scientists with deep knowledge of chemistry and many years of experience, that follow internationally recognized methodologies and development guides.
To support activities within pharmaceutical development, we offer a wide range of analytical services: Development and validation of analytical methods, transfers, ICH stability studies, impurity monitoring, isolation and identification, particle size and distribution, microbiological studies, etc.
We have the necessary software and equipment for the development of printed materials, from labels, instructions and boxes and everything that is required. There is a robust procedure to ensure full regulatory compliance and labeling standards, as well as the generation of specifications necessary to facilitate its manufacture.
Technology Transfer and Escalation
We start from a detailed risk analysis that shows the action plan for technology transfer and industrialization of production, based on the definition of critical process parameters.
The transfer, scaling and validation of processes is carried out respecting international guides and aligned to the standards required by the client.
All documentation collected and generated for pharmaceutical developments is stored physically and electronically, facilitating the regulatory assembly required to submit the development to a new drug request.
Local Administration for Health Registry
Given the experience and local knowledge for the management in obtaining a Sanitary Registry, ULSA TECH offers the support and the management to submit and follow up on the application of Sanitary Registries in the country.
Purchase, Production, Storage and Distribution
Through an S&OP process with the customer, we offer the complete manufacturing package, including the purchase of raw materials, consumables and materials. Also, during a defined period, you can store and deliver the finished products to the place requested by the customer, either in cold chain or temperature controlled. Normally this work model has a much more efficient supply chain, resulting in efficient and short processes.
We are a pharmaceutical company focused on affordable cancer treatment medicines of the highest quality , with the purpose of improving the lives of people around the world.
Av. Dr. Roberto Michel No. 2546
Parque Industrial el Álamo,
C.P. 44490 Guadalajara, Jalisco, México.
(+52) 33 3001 6800