Analytical services that rival none
HGA Biomed’s comprehensive range of contract manufacturing services includes all quality control and analytical services necessary to ensure stability, consistency and regulatory compliance.
IN-HOUSE EXPERTISE BRINGS
Our highly-experienced staff performs the following core competencies and additional analytical services from our in-house laboratory facilities. Our ability to provide fully-integrated contract manufacturing support allows us to maintain the highest standard of quality, and to provide partners with end-to-end customer support through every step of the process.
Development and validation services:
Our analytical laboratory undertakes the development and validation of liquid chromatography (HPLC) methods for product transfers and product development, and the preparation of quality specifications directly supporting the registration process.
In addition to our own original innovations, we carry out development activities for our customers and accompany the product throughout its life-cycle. Our goal is to enable our customers to have access to a single-window system with the involvement of our contracted laboratory network.
- Testing of raw materials, semi-finished and finished products according to pharmacopoeia or customer specification.
- Development and validation of analytical methods.
- Carrying out stability tests under different climatic conditions (long-term test, accelerated test, in-use test), preparation of stability protocol and reporting.
- Manufacture and release of liquid and semi-solid test products for clinical trials.
- Preparation of technical and production documentation, professional support of the registration process.
- In order to perform microbiological tests, we involve audited subcontractors to support the quality of our development and production activities.
- Release of finished and semi – finished products for transport and placing on the market.
Make our manufacturing services work for you: Contact us
Contact us to discuss how we can collaborate to meet your contract manufacturing needs.
Our team will respond to your inquiry within one business day of receipt.