Peptides in GMP quality
Within our GMP facility located in Tübingen, Germany, we will possess the necessary resources to manufacture high-quality GMP grade peptide therapeutics. We work closely with the Regierungspräsidium Tübingen to ensure excellence at each step of our manufacturing process.
Regarding GMP compliance, we will maintain a rigorous approach. Our personnel, premises, equipment, materials, procedures, and storage conditions are all subject to inspections by regulatory authorities. Rest assured, our commitment to excellence guarantees the quality and integrity of your peptide therapeutic.
We will achieve the following certifications:
German Manufacturing licence
For peptide based investigational medicinal prodcuts
Pharmaceutical cGMP certification
For peptide based drug substances and products
ISO 9001 certification
ISO 9001 is an internationally recognized standard for quality management systems, indicating that we have implemented effective quality management practices.
European Medicines Agency (EMA) certification
EMA certification indicates compliance with European Union regulations for pharmaceutical manufacturing, ensuring adherence to strict quality standards.
Good Manufacturing Practice (GMP)
Highly qualified and trained personnel
Our manufacturing process will be executed by personnel who possess extensive qualifications and training.
Adequate premises and spaces
Our manufacturing facility will be thoughtfully designed with sufficient space to facilitate the hygienic and efficient production of medicinal products. We prioritize an environment that fosters productivity and adheres strictly to rigorous quality standards.
Appropriate equipment and services
We will utilize state-of-the-art equipment, specially selected for the GMP production of peptides. Our equipment will undergo regular maintenance to maintain consistent peptide therapeutic quality.
Correct materials, containers, and labels
We will meticulously choose top-quality materials, containers, and labels for our manufacturing process. Our innovative labeling and handling system will safeguard the integrity of your peptide therapeutics.
Approved procedures and instructions, aligned with the Pharmaceutical Quality System
Our manufacturing process will abide strictly by approved procedures and instructions. Our unwavering dedication to compliance and quality control will ensure that your peptide therapeutics consistently meet the highest quality standards.
Suitable storage and transportation
We will prioritize proper storage and transportation conditions to preserve the quality of your peptide therapeutics from our facility to your clinical trial site.
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