completed projects. Conceptual solutions, project documentation, working documentation.
15+
сompleted laboratory developments of API production technologies
5+
technologies for the production of complex products (medical products, cosmetics, household chemicals)
5+
API pilot production scaling projects
100+
scientific technologies and product competencies
Technological design and engineering, process environment engineering;
Development of technologies for the chemical synthesis of active pharmaceutical ingredients (API) from laboratory to industrial level.
Advantages
Our employees have many years of design experience and have competencies in a wide range of areas. The synergy effect of working together makes every next project even better.
We know how to optimize technological and engineering solutions in order to minimize capital and operating costs.
We are able to communicate in the same language with all project participants - the customer, the general designer, engineers, designers, architects, experts, suppliers.
Our specialists carefully study all the subtleties of the technology. Thanks to this, we create a rational and comfortable working environment.
To implement complex tasks and unique ideas of the customer, we use the iteration method, which allows us to most fully develop a production strategy and move towards its implementation.
We make high-quality projects, keeping in mind the regulatory requirements and taking into account the preferences of the customer. This is the key to a smooth examination, rapid construction and commissioning of the facility.
Our employees have many years of experience in pharmaceutical development and have all the competencies to create API synthesis technologies of any complexity from laboratory to industrial level.
To implement complex tasks and understand the needs of the customer, we use the iteration method, which allows us to fully develop a strategy for working on the product and move towards its implementation.
The competencies of our team allow us not only to develop and validate the API production technology, but also to transfer the developed technology to the Customer’s site.
If necessary, our team can develop and certify API primary reference standards, obtain and certify API impurities.
This makes it possible to carry out the stages of pharmaceutical development at the laboratory and pilot scale levels. We carry out not only the development of technology, but also full analytical support for all stages of synthesis, including the development of methods for monitoring raw materials, intermediate synthesis products and the finished product. We develop specifications with quality indicators and acceptance criteria determined during development. We study the stability of intermediates and APIs, as well as validate analytical quality control methods.
Pharmaceutical development is carried out in strict accordance with GMP rules and ICH recommendations. All stages of work are transparent and full traceability of actions is ensured.
Services
We help to develop design task orders, determine the parameters, cost, energy requirements of your future facility.
We create synthesis technologies from active pharmaceutical ingredients to a wide variety of organic compounds, for example, agrochemical products and fine organic synthesis products.
Our team has all the necessary competencies in the development of chemical synthesis technologies and analytical methods. Many years of experience and regular professional development allow our team to transfer technologies from the laboratory to the pilot and industrial level.
Pharmaceutical production, medical device manufacturing, chemical industry, microelectronics, technological and industrial parks, logistics complexes, food industry, medical institutions, research and development complexes.
According to the current regulatory documentation, the preparation of a design task order is entrusted to the developer or technical customer. If you have any difficulties in preparing a design task order, we will help you prepare it.
Yes, we can develop for you a process procedure for design
Yes, we can choose the process equipment that meets your needs.
We can determine which building you need for your project by performing a step-by-step design. As a first approximation, the company's specialists conduct an expert assessment, which will allow you to get aggregated information about the proposed facility. At this stage, you can either make adjustments to the design task order, or continue working on the project to execute the concept project. The result of the concept project will be the parameters of the facility, the estimated cost, the energy requirements. After the concept, you can decide on the need to develop design and working documentation
The necessity of passing the expert examination is described in the regulatory documentation, it depends on the parameters of the facility. We can advise you on the need for expert examination, based on the initial data you have.
We can audit the documentation you have for compliance with the current regulatory documentation, design task order.
Leave a Request
Tell us about the tasks of your company, and we will find the best technological solutions for your production.