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Enhanced Manufacturing Capabilities
Welcome to HelgeHeim, a paradigm of Enhanced Manufacturing Capabilities in the pharmaceutical industry. With a legacy rooted in experience and an uncompromising commitment to quality, we specialize as a Contract Manufacturing Organisation (CMO) in the production of high-potent sterile products.
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About us
At HelgeHeim, we believe that great partnerships are built on trust, reliability, and a mutual commitment to quality.
With our Enhanced Manufacturing Capabilities, we take care of every step in the production process for you, from formulation to the final product.
When you choose us as your Contract Manufacturing Organisation (CMO), you're choosing a partner that values your time and trust. Rest assured, your products will reach their destination as promised, without you having to lift a finger.
Our Facilities
When it comes to pharmaceutical manufacturing, the quality of the facility plays a pivotal role, not just in product development but also in client peace of mind. That's why we adhere strictly to the EU narcotic medicines legislation and follow GMP standards as defined in the EU EudraLex Vol. 4 legislation.
Our factory, equipped with Enhanced Manufacturing Capabilities, is structured to minimize your worries while maximizing efficiency. What this means for you is a reliable and compliant manufacturing partner.
Our Facilities Features
Administration Building Area
A dedicated space designed for the rest and well-being of our employees, because a focused team leads to high-quality outcomes.
Production Area
An expansive 4,000 square meters tailored to accommodate state-of-the-art manufacturing processes and machinery.
Laboratories Area
1,000 square meters allocated to cutting-edge chemical, physical, and microbiological laboratories.
Stability Chambers
In compliance with ICH Q1A(R2) guidelines to ensure your product remains efficacious under different environmental conditions.
Warehouse Areas
Temperature-controlled storage facilities, ranging from ambient storage at 15-25 degrees Celsius to cold storage at 2-8 degrees Celsius, guarantee the integrity of your products.
Security Measures
A fortified perimeter coupled with round-the-clock monitoring, specially designed to meet and exceed the stringent requirements for narcotic medicines regulations. In essence, our facilities are not just structures of brick and mortar but a testament to our commitment to seamless, reliable service.
Services
Our facility is purpose-built to offer a comprehensive suite of services that cater to the intricate demands of pharmaceutical manufacturing. Below is a detailed overview of our capabilities:
Laboratories
Services
in Technology and Process Transfers
Each of our services is executed with meticulous attention to detail, ensuring that when you partner with us, your product is in skilled and reliable hands.
Quality Assurance
At HelgeHeim, quality isn't just a department—it's a philosophy that permeates everything we do. From raw material selection to the finished product, our quality assurance protocols are rigorous, ensuring we meet and exceed international standards.
Project Roadmap
Project
Roadmap
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