SERVICES TO
INDUSTRY

Why us?

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.

Our technologies and capabilities

We offer a wide range of capabilities to address the specific needs of your pharmaceutical product, which include:

Injectable solutions and lyophilized injectable solutions

In fully automated and self-contained processes for the management of Highly Potent Application Programming Interfaces (HPAPIs), guaranteeing the stringent quality for a sterile product, as well as the protection of our collaborators.
With ample flexibility to manufacture small pilot batches, as well as commercial batches of small, medium and large volumes in presentations from 3 mL to 50 mL.

Injectable suspensions and lyophilized injectable suspensions

At UlsaTech we can develop and scale injectable suspensions to commercial batches under the strictest standards of aseptic processes.
We have the highest technology for micro-encapsulation processes in both polymeric and liposomal microspheres, which are ideal for controlled drug release applications, with high biocompatibility and bioavailability.

Oral Solids

We have the infrastructure for the production of coated tablets and capsules with blister or bottle packaging.
To adapt the size and morphology of particles necessary to achieve expected bioavailability and fluid process, we have wet granulation process with spray drying. Also, dry mixes and high flexibility in batch sizes, tablet sizes and blister formats.

Services

 

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
•Pricing Quotations

Pharmaceutical Development

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.

Analytical Development

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.

Materials Development

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.

Dossier Assembly

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.

ULSA TECH

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.

CONTACTO

Av. Dr. Roberto Michel No. 2546
Parque Industrial el Álamo,
C.P. 44490 Guadalajara, Jalisco, México.

(+52) 33 3001 6800

ventas1@ulsatech.com.mx
sales@ulsatech.com.mx