As the global leader in pharmaceutical grade biopolymers, we have a responsibility to guarantee our partners biopolymers of exceptional purity, absolute safety and exemplary consistency.
Our quality system is built on total process control, from bacterial fermentation to ultra-purification, ensuring unrivalled batch-to-batch consistency. Thanks to decades of expertise without any batch recalls, HTL Biotechnology has been able to impose a quality standard that is now the benchmark for pharmaceutical-grade biopolymers.
Internationally recognised and certified quality
Our facilities in France comply with the strictest pharmaceutical industry standards and are GMP and ISO 13485 certified. We are regularly audited by international health authorities (FDA, ANSM, PMDA, MFDS) and by our clients. These certifications and regular inspections attest to our rigour and commitment to our customers and patients.
Regulatory support that goes further
More than a supplier, HTL Biotechnology is a strategic partner. Our dedicated regulatory teams provide:
Global and local expertise
Tailored support for product registration
Assistance with health authority submissions
Ongoing regulatory intelligence
By choosing HTL Biotechnology, our customers gain more than a premium ingredient, they gain a trusted partner to bring innovation.
Marie-Armelle Flo’ch, Chief Quality and Regulatory Affairs Group
Beyond together to achieve the highest quality standard. All our products are GMP-compliant.
Our commitment to safety and excellence is easily demonstrated : no batch recalls in three decades, audited and certified by the FDA (USA), ANSM (France), PMDA (Japan) and MFDS (Korea).
GMP
ISO 13485
This international standard guarantees the quality of the design and manufacturing of our raw materials for medical devices, ensuring full compliance with regulatory and client requirements in terms of quality, safety and efficacy.
Halal
