Ensuring the safety and efficacy of medications with FDA-approved laboratory services.
Alphalytic
Founded in 1995 and based in Berlin, Alphalytik Pharmaservice GmbH is an independent laboratory specializing in pharmaceutical analytics. The company's primary focus is on ongoing stability testing, a critical service that assesses the long-term effects of environmental factors on the shelf life of pharmaceutical products. These tests ensure that medications remain safe and effective throughout their entire lifecycle.
In addition to stability testing, Alphalytik offers method development and validation, stress testing, and release testing. The company also has expertise in complex analytics for low-dosage and hormone-based products. Alphalytik serves a wide range of clients within the pharmaceutical industry, maintaining long-standing relationships with many of them. Its status as an FDA-approved laboratory highlights its reputation for high standards and reliability.
With a team of professionals, Alphalytik is well-positioned in the pharmaceutical laboratory analytics market and enhances CERTANIA’s service portfolio in the life sciences sector.
Focus topics
- Analytical Solutions
- GMP Consultation
- Pharmaceutical Testing
- Custom Solutions
- Regulatory Expertise
location
Berlin, Germany
Partner website
Partner since
Founding year
Our focuses:
Comprehensive Analytical Solutions for the Pharmaceutical Industry
Alphalytik specializes in delivering advanced analytical services, including stability testing, purity analysis, and methods validation. By adhering to strict Good Manufacturing Practice (GMP) guidelines, the company ensures that pharmaceutical products meet global quality and safety standards. Their services are tailored to support product development and lifecycle management.
Regulatory and GMP Consultation
Alphalytik offers expert consultation on GMP compliance, regulatory audits, and staff training. With extensive experience in pharmaceutical regulation, they help companies navigate the complexities of legal requirements, ensuring that manufacturing processes and products comply with industry regulations.
Custom Pharmaceutical Testing Services
Alphalytik provides a range of pharmaceutical testing services, such as microbiological safety tests, dissolution analysis, and environmental stability studies. These services are designed to confirm the safety, effectiveness, and regulatory compliance of pharmaceutical products in various environmental conditions.
Tailored Solutions for Complex Challenges
Alphalytik excels in offering customized solutions for unique regulatory challenges. Whether addressing specific product requirements or providing assistance with complex compliance issues, the company leverages over 30 years of experience to support pharmaceutical manufacturers in maintaining quality and regulatory standards throughout their processes.