Skip to Main Content
Welcome to the Scientist.com Marketplace

Go to Main Navigation

Analytisches Zentrum (AZ) Biopharm GmbH Berlin

Start a request
Year Established:
2002
Website:
az-biopharm.de
Headquarters:
Berlin, Berlin, DE
Company Type:
Small Business (1-10M TTM Revenue)
Certifications:

Analytical Center Biopharm GmbH is a GLP and GMP certified testing facility (CRO) with many years of experience in bioanalytical and pharmaceutical testing of human and veterinary drugs. We focus on the content of active substances and, where applicable, their metabolites in biological matrix (pharmacokinetic and bioavailability studies, residue analysis in edible farm animal tissues), stability testing and physicochemical analysis of intermediates according to the Chemicals Act of Germany.
We offer you:
• Tailored solutions and individual offers
• Qualified GLP and GMP-compliant analytics
• Competent and speedy advice and project processing
• Comprehensive reporting in German and / or English
• A high standard of quality, guaranteed by our independent quality assurance and constantly evolving
• Qualified / validated test equipment, which is subject to the continuous control of the QSE and meets the requirements of 21 CFR Part 11

Range of services:
• Method development and validation (also for highly active and toxic substances)
• Stability tests (storage for ICH conditions, also for BTM)
• Quality control of pharmaceutical raw materials, excipients and finished products according to Pharmacopoeia (PhEur, USP, JP etc) and according to customer methods
• Determination of the content of active pharmaceutical ingredients and their metabolites in biological matrix (including urine, plasma, serum, wound secretions)
• Residue analysis in tissues of farm animals and in milk
• Testing of intermediates according to chemical act (ChemGes)

The AZ Biopharm is distinguished in particular by
• Fast response times
o 15- 20 working days for the processing of orders for pharmaceutical analysis
o 5 working days from last sample measured in bioanalytics to the delivery of QA-th results
o 10 working days from the provision of the final results in bioanalytics to the provision of the draft report
Special experience
• More than 200 BE studies with a positive authority vote with regard to bioanalytics
• Carrying out numerous release studies
Capacity
• Over 75,000 study samples per year in bioanalytics
• Test of 200 pharmaceutical batches per month
• Walk-in climate chambers according to ICH conditions
• Walk-in freezer at -20 ° C for storage of bioanalytical samples
• Additional climate cabinets for other climates and freezers at -80 ° C

Site Badges
Analytisches Zentrum (AZ) Biopharm GmbH Berlin
19 Bitterfelder Straße Berlin, Berlin, 12681 Germany

Get started

If your organization has a Scientist.com marketplace, you can log in here to order products and services directly.

If you're interested in ordering custom research services from suppliers in the Scientist.com network, book a meeting with our team here.

To order products instantly, request access below.

Password must:

• Be at least 12 characters in length

• Contain a lowercase letter (a-z)

• Contain an uppercase letter (A-Z)

• Contain a numeral (0-9)

• Contain a special character (%, $, !, @)

By signing up for this account you agree to the Terms of Service