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.

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.


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:

Manufacturing Services for Vials
Batch Sizes Ranging from 50 to 5,000 Liters
Filling Capacities Spanning 1 ml to 100 ml Vials
Annual Throughput: 36 Million 2 ml Vials / 25 Million 50 ml Vials
Cutting-edge Isolator Technology
Precision-driven Aseptic Filling
Advanced Lyophilization Techniques
Rigorous Terminal Sterilization Processes
Full Traceability with 100% Unit Identification throughout the Manufacturing Process
Automated Visual Inspections
Comprehensive Serialization and Aggregation
Manufacturing Services for Non-PVC Plastic Bags
Batch Sizes Extending from 500 to 10,000 Liters
Filling Capacities from 50 ml to 5,000 ml
State-of-the-art Form-Fill-Seal Technology
Options for Single and Double Chamber Bags
Annual Throughput: 25 Million Liters
Superior RABS Technology
Strict Terminal Sterilization
Uncompromising 100% Visual Inspection
End-to-end Serialization and Aggregation
Expertly Managed Chemical Laboratories for Impeccable Formulation Integrity
Physical Testing Units Compliant with Global Quality Standards
Microbiology Laboratories Utilizing Cutting-edge Technologies for Unwavering Safety and Reliability
Secure Storage and Distribution Compliant with Stringent Regulations and High Standards
Extensive Regulatory Support Tailored to Your Needs
A Dedicated Team Specialized
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


Contact us

Your journey towards pharmaceutical excellence begins here. Contact us at helgeheim@helgeheim.com to discover how HelgeHeim's Enhanced Manufacturing Capabilities can elevate your product to the next level.