Contract manufacturing, secondary packaging and kitting for pharma and medical technology, as well as packaging and fulfillment services for food.
Activoris Medizintechnik GmbH (Activoris Firmengruppe)
Gemünden (Wohra) · Gauting · SchwalmstadtNew on Amplifa
About Activoris
The Activoris Group, headquartered in Gemünden (Wohra), is a technology and outsourcing partner for the medical technology, pharmaceutical and food industries. Activoris Medizintechnik GmbH offers contract manufacturing and secondary packaging for the pharmaceutical and medical technology industries, including the packaging and labeling of human medicines, batch release of sterile products and quality control (chemical/physical). In addition, the company handles kitting and logistics for clinical trials as well as the import of investigational medicinal products including quality control. For product development, Matrix ALM is used in accordance with the requirements of the Medical Device Regulation (MDR). Activoris Food Packaging GmbH offers cost-efficient packaging and fulfillment services for the food and confectionery industry, in particular purchasing, sales, storage and picking of pre-packed chocolates and chocolate products, including sorting and labeling. A fourth business unit offers tailored corporate administration for start-ups with life science experience. For the US market, there is a partnership with AJW Technology Consultants (Tampa, Florida) as U.S. Agent and regulatory representative.
- Site
- Gemünden (Wohra)
- Processes
- Secondary packaging (packing) of human medicines, Batch release of sterile products, Quality control (chemical/physical): inspection for completeness and integrity,, Import of investigational medicinal products incl. quality control of imported medicines, Kitting and logistics for clinical trials, Contract manufacturing for the pharmaceutical and medical technology industries, Labeling of pre-packed chocolates/chocolate products, Sorting of pre-packed chocolates/chocolate products
- Materials
- Secondary Packaging (Packing), Batch Release of Sterile Products, Quality Control Chemical/Physical, Clinical Trial Kitting, Import of Investigational Medicinal Products, Food Fulfillment
- Certificates
- DIN ISO 13485:2016, GMP (Manufacturing/Import Authorization DE HE 01 MIA 2025 0026), Manufacturing/Import Authorization (German Medicines Act, §13 para. 1, §72, IFS Wholesale Version 2, May 2016 "Plus" (Higher Level), ISO 13485:2016, GMP (DE HE 01 GMP 2025 0084), Manufacturing/Import Authorization (DE HE 01 MIA 2025 0026), IFS Wholesale V2 Plus (Higher Level)
- Industries
- Medical Technology, Pharmaceuticals, Food / Confectionery Industry, Life Sciences
- 01
Product development (Matrix ALM, MDR)
- 02
Contract manufacturing
- 03
Secondary packaging (packaging, labeling)
- 04
Quality control (chemical/physical)
- 05
Batch release of sterile products
- 06
Kitting and logistics for clinical trials
- 07
Import of investigational medicinal products
- 08
Fulfillment and order picking
Services and Processes
Secondary Packaging (Packing)
Contract-based secondary packaging of human medicines under manufacturing/import authorization, including label removal.
Batch Release of Sterile Products
Release of sterile medicinal product batches by the Qualified Person in accordance with GMP.
Quality Control Chemical/Physical
Inspection for completeness and integrity as well as documentation checks.
Clinical Trial Kitting
Kitting and logistics so that medicines reach the study center at the right time in the right quality.
Import of Investigational Medicinal Products
Import of Phase I–III investigational medicinal products including quality control of imported medicines.
Food Fulfillment
Purchasing, sales, storage and picking of pre-packed chocolates/chocolate products, including sorting and labeling.
Locations
Gemünden (Wohra)
DEHeadquarters and administration, production Activoris Medizintechnik GmbH and Activoris Food Packaging GmbH
- Materials
- Human medicines, investigational medicinal products, food
Gauting
DEDevelopment Activoris Medizintechnik GmbH
Schwalmstadt
DEProduction Activoris Food Packaging GmbH
- Materials
- Pre-packed chocolates/chocolate products
Industries
Processes & technical limits
| Processes | Tolerance | Max. part | Weight | Lot size | Materials |
|---|---|---|---|---|---|
| Secondary packaging (packing) of human medicinesAssembly | – | – | – | – | – |
| Batch release of sterile productsTesting | – | – | – | – | – |
| Quality control (chemical/physical): inspection for completeness and integrity,Testing | – | – | – | – | – |
| Import of investigational medicinal products incl. quality control of imported medicinesAssembly | – | – | – | – | – |
| Kitting and logistics for clinical trialsAssembly | – | – | – | – | – |
| Contract manufacturing for the pharmaceutical and medical technology industriesAssembly | – | – | – | – | – |
| Labeling of pre-packed chocolates/chocolate productsAssembly | – | – | – | – | – |
| Sorting of pre-packed chocolates/chocolate productsAssembly | – | – | – | – | – |
| Purchasing, sales, storage and picking of pre-packed chocolates/chocolate productsAssembly | – | – | – | – | – |
Additional services
Quality Management
The Activoris Group maintains a quality management system that is regularly reviewed and improved (DIN ISO 13485:2016). For medicinal product manufacturing, there is a GMP compliance confirmation from the Hessian State Office for Health and Care (Hessisches Landesamt für Gesundheit und Pflege); for the food division, an IFS Wholesale certificate at Higher Level.
| Evidence | Gemünden (Wohra) | Schwalmstadt |
|---|---|---|
| ISO 13485:2016 | ||
| GMP (DE HE 01 GMP 2025 0084) | ||
| Manufacturing/Import Authorization (DE HE 01 MIA 2025 0026) | ||
| IFS Wholesale V2 Plus (Higher Level) |
History
- 2024
IFS Wholesale certificate (V2 Plus, Higher Level) for Activoris Food Packaging GmbH, issued by TÜV SÜD, valid until 18.11.2025.
- 2025
GMP certificate (DE HE 01 GMP 2025 0084) and manufacturing/import authorization (DE HE 01 MIA 2025 0026) following inspection on 19.03.2025, issued on 30.04.2025.