Eurofins BioPharma Product Testing in Germany

Eurofins BioPharma Product Testing Hamburg GmbH

Am Neuländer Gewerbepark 2 
D-21079  Hamburg
GERMANY

Eurofins BioPharma Product Testing Munich GmbH

With more than 30 years of experience and thousands of GMP/GLP studies per year Eurofins BioPharma Product Testing Munich GmbH supports its clients especially in the fields of in vitro toxicology, bioassays, microbiology, biocompatibility, immunoanalytical and bioanalytical studies.

We cover the whole range from standardized test to special requirements and tailor-made studies. We are certified in accordance with GLP (Good Laboratory Practice) and GMP (Good Manufacturing Practice) and have been accredited with DIN EN ISO 17025 for the testing of medical devices. We are listed by the World Health Organization (WHO) and have been audited successfully by the FDA. In addition our preferred partner BSL BIOSERVICE in Munich received full accreditation by AAALAC (Association for the Assessment and Accreditation of Laboratory Animal Care).

Our comprehensive Service Portfolio includes:

Testing Services for Pharmaceuticals, Biologics & ATMPs

• Process and Product Related Impurities
• Bioassays
• Method Development & Validation
• Stability & Release Testing
• Sterile & Non-Sterile Product Testing
• Leachables & Extractables Testing
• Immunoanalytical Studies
• Bioanalytical Studies
• Toxicology Studies
• Pharmacology Studies

Testing Services for Medical Devices

• Biocompatibility Testing
• Cytotoxicity Tests
• Sensitization Studies
• Irritation Studies
• Hemocompatibility Testing
• Microbiological Testing
• Implantation Studies (in collaboration with partner laboratory)

Testing Services for (Agro)chemicals, Cosmetics and Food Additives

• Irritation Studies
• Sensitization Studies
• Local Tolerance Studies (in collaboration with partner laboratory)
• Genetic Toxicology

Accreditations/Certifications/Registrations:

• GLP
• GMP compliant
• DIN EN ISO 17025
• FDA audited
• Listed by the World Health Organization (WHO)

Eurofins PHAST GmbH

Eurofins PHAST GmbH is the flexible laboratory service Provider for human and veterinary drug products.

• Small Molecules

• Biologics/Large Molecules

Analytical Development, Quality Control

• Analytical support (e.g. structure elucidation, drug analysis)

• Drug development services (e.g. method development and validation, stability studies incl. controlled storage)

• Market supply (e.g. batch release testing, batch release by QP, stability studies incl. controlled storage)

• Clinical Trial Supply Management (CTS)

• On-Site Services (Insourcing with Eurofins Professional Scientific Service^®)

Reference Standards

• You can find your daily analytical needs of USP Reference Standards in our webshop for professionals, incl. customs clearance/EU import.

• In addition in our webshop for professionals we offer EDQM / Ph.Eur. Reference Standards

• USP training courses on monograph-compliant handling of reference standards can also be found at www.reference-standards.com 

The laboratories in Homburg and Constance are GMP-certified. The multiple successful inspections by the U.S. FDA are additional confirmation for the customers of Eurofins PHAST for permanently highest quality level.

Eurofins PHAST operates a biological safety level 2 laboratory (BSL 2).

As a strategic partner, Eurofins PHAST GmbH assumes worldwide responsibility for quality in the development and manufacture of pharmaceuticals - all services: one-stop contact!

Accreditations/Certifications/Registrations:

• GMP compliant
• FDA audited

Eurofins PHAST Development GmbH & Co.  KG

Eurofins PHAST GmbH is the flexible laboratory service Provider for human and veterinary drug products.

• Small Molecules

• Biologics/Large Molecules

Analytical Development, Quality Control

• Analytical support (e.g. structure elucidation, drug analysis)

• Drug development services (e.g. method development and validation, stability studies incl. controlled storage)

• Market supply (e.g. batch release testing, batch release by QP, stability studies incl. controlled storage)

• Clinical Trial Supply Management (CTS)

• On-Site Services (Insourcing with Eurofins Professional Scientific Service^®)

Reference Standards

• You can find your daily analytical needs of USP Reference Standards in our webshop for professionals, incl. customs clearance/EU import.

• In addition in our webshop for professionals we offer EDQM / Ph.Eur. Reference Standards

• USP training courses on monograph-compliant handling of reference standards can also be found at www.reference-standards.com 

The laboratories in Homburg and Constance are GMP-certified. The multiple successful inspections by the U.S. FDA are additional confirmation for the customers of Eurofins PHAST for permanently highest quality level.

Eurofins PHAST operates a biological safety level 2 laboratory (BSL 2).

As a strategic partner, Eurofins PHAST GmbH assumes worldwide responsibility for quality in the development and manufacture of pharmaceuticals - all services: one-stop contact!

Accreditations/Certifications/Registrations:

• GMP compliant
• FDA audited

inpac Medizintechnik GmbH 

Inpac Medizintechnik GmBh is a provider of cleaning, assembly, packaging, and sterilization services for the medical technology, biotechnology and pharmaceutical industries. With over 15 years of experience and compliance with the major standards (EN ISO 13485:2016 incl. 11135:2014, FDA, MHLW), Inpac strives to fulfill customer expectations by offering comprehensive scope of services and developing custom-tailored solutions – from development to market supply.

Accreditations/Certifications/Registrations:

• EN ISO 13485:2016 incl. 11135:2014 
• FDA audited
• MHLW registration