Alpha-Pharma-Service
Alpha-Pharma-Service GmbH is a comprehensive pharmaceutical and analytical service provider based in Heilbronn, Germany. The company specializes in pharmaceutical quality control, analytical testing, regulatory consulting, and manufacturing support for pharmaceuticals, medical devices, cosmetics, and food products. With a history dating back to 1985, Alpha-Pharma is committed to quality, compliance, and customer support, offering services such as stability testing, analytical method development, dossier preparation, and certification. The company aims to support clients in product approval, quality assurance, and regulatory compliance, ensuring safe and effective products in the pharmaceutical, food, and cosmetic industries.
Industries
Nr. of Employees
small (1-50)
Alpha-Pharma-Service
Heilbronn, Baden-Wurttemberg, Germany, Europe
Services
Outsourced analytical testing for identity, content, purity and stability for pharmaceutical, food, cosmetic and medical device clients, performed according to applicable standards.
Provision of climate chamber and cabinet space for stability storage with permanent online monitoring, documentation and sample retrieval/shipment.
Development and validation of analytical procedures for routine use, including method optimization and transfer readiness.
Assessment, update and compilation of regulatory dossiers for medicinal products including Module 3 quality documentation and eCTD assembly, in collaboration with partner firms when required.
Classification support, preparation and review of technical documentation and biological/clinical safety assessments for medical devices and coordination with notified bodies.
Review of cosmetic formulations and labeling, preparation of product information files and performance of safety assessments per EU cosmetics regulation.
Outsourced analytical testing for identity, content, purity and stability for pharmaceutical, food, cosmetic and medical device clients, performed according to applicable standards.
Provision of climate chamber and cabinet space for stability storage with permanent online monitoring, documentation and sample retrieval/shipment.
Development and validation of analytical procedures for routine use, including method optimization and transfer readiness.
Assessment, update and compilation of regulatory dossiers for medicinal products including Module 3 quality documentation and eCTD assembly, in collaboration with partner firms when required.
Classification support, preparation and review of technical documentation and biological/clinical safety assessments for medical devices and coordination with notified bodies.
Review of cosmetic formulations and labeling, preparation of product information files and performance of safety assessments per EU cosmetics regulation.
Expertise Areas
- Analytical chemistry and pharmacopeial testing
- Stability studies and controlled-climate storage
- Regulatory compliance for pharmaceuticals, medical devices, cosmetics and foods
- Analytical method development and validation
Key Technologies
- High-performance liquid chromatography (HPLC)
- Diode-array detection (DAD)
- UV-Vis spectroscopy
- Karl Fischer water determination
News & Updates
Rent a climate - Online-monitored storage solutions
Alpha Pharma offers storage with permanent online monitoring for stability testing in climate chambers.
Analytik - Modern analytical services for various industries
The company provides analytical services including GMP-certified testing, manufacturing permits, and ISO certifications.
Leistungsspektrum - Comprehensive service offerings
A wide range of services including pharmaceutical quality control, method validation, and consulting.
Gutachten - Expert reports and assessments
Preparation of expert reports according to current standards, including quality summaries and evaluations.
Analyseverfahren - Advanced analytical methods
Instrumental and physico-chemical analytical techniques including HPLC, GC, UV-Vis, and more.
Portfolio - Diverse service spectrum
Services in pharmaceutical, food, cosmetic, and medical device sectors.
Rent a climate - Online-monitored storage solutions
Alpha Pharma offers storage with permanent online monitoring for stability testing in climate chambers.
Analytik - Modern analytical services for various industries
The company provides analytical services including GMP-certified testing, manufacturing permits, and ISO certifications.
Leistungsspektrum - Comprehensive service offerings
A wide range of services including pharmaceutical quality control, method validation, and consulting.
Gutachten - Expert reports and assessments
Preparation of expert reports according to current standards, including quality summaries and evaluations.
Analyseverfahren - Advanced analytical methods
Instrumental and physico-chemical analytical techniques including HPLC, GC, UV-Vis, and more.
Portfolio - Diverse service spectrum
Services in pharmaceutical, food, cosmetic, and medical device sectors.