With 25 years of proven experience, HTL is recognized for producing non-animal Hyaluronic Acid that features the highest standards of quality and functionality. HTL is creating and delivering innovative biopolymer solutions, thanks to a unique combination of biotechnology and chemistry expertise in GMP environment.
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Quality, Safety and Compliance
As a trusted supplier of ingredients and raw materials for the pharmaceutical and medical devices industries, HTL is committed to continuously matching their quality and regulatory requirements.
- HTL Production and Quality System are compliant with the cGMP Part II for the manufacture of Active Pharmaceutical Ingredients (ICH Q7);
- The HTL production site is periodically inspected by the FDA and the ANSM;
- Hyaluronic Acid produced by HTL follows the requirements of the EP monograph.
Our high level of client satisfaction has always been a great source of pride for us. It is the embodiment of the resources and efforts we invest in our quality system.
Commitment to excellence in client satisfaction
We are an integrated organization of passionate experts with a state of mind unique in our field. In every client project, we apply a high level of commitment and dedication. We have built our organization on the principle of consistently understanding and meeting the specific needs of our clients from the earliest product development stages to market success. We provide our clients with support and guidance throughout the process, from R&D to Technical, Analytical and Quality & Regulatory matters.
We make good use of the complementarity of our technical expertise to generate value for our clients and their brands. We co-create customized solutions by understanding our client’s specific needs, converting them into biopolymer attributes and solutions to deliver a tailor-made product meeting critical quality and functional requirements.
Our R&D and Quality Assurance teams are committed to facilitating our clients’ use of our solutions. We help them preserve the properties of our biopolymers by assisting with the implementation of our raw materials in their processes. We also provide troubleshooting support.
We support our clients with our extensive analytical capabilities by supplying analytical data on our ingredients as well as their medical devices, such as average molecular weight and distribution by size-exclusion chromatography, rheology, bacterial endotoxins by the kinetic chromogenic method. We also make our expertise available to our clients by developing analytical methods that align with their specific requirements.
Quality and Regulatory support
The organization established by HTL ensures that our clients are able to maintain compliance with the evolving requirements of their own supervisory bodies. We respond favorably to all requests for customer audits, and we support our clients in the creation and update of their regulatory files.
HTL has filed DMFs in different parts of the world, including the EU, USA, Japan, Korea, India and Russia.
CEPs are accepted in many countries: EU member states and member states of the convention on the elaboration of a European Pharmacopoeia (except Ukraine), in Canada, New Zealand, Singapore, Australia and other countries. CEPs are also accepted (with conditions) by the Taiwan Food and Drug Administration.
HTL supports its clients in worldwide market registration by providing letters of access and necessary regulatory documentation, replying to inadequacy letters issued by Health Authorities within the stipulated deadline, and by applying for DMFs in other countries upon request.