Company Info

Hameln Pharmaceuticals GmbH

CDMO

Overview

Hameln pharmaceuticals gmbh is engaged in contract manufacturing of parenteral solutions and suspensions. hameln pharmaceuticals gmbh operates through two divisions:

hameln pharma – focused on contract manufacturing, product compliance service, water for injections dossiers and quality;

hameln rds – focused on contract development, dossiers, regulatory affairs services and supply of API and finished products.

The company’s product compliance services: risk analysis based on the HACCP concept, product transfer and product establishment, scale-up, method development, validation, stability studies, etc. Its contract development services: project evaluation, project plan, galenical development to verify the chosen formulation in the chosen primary packaging material, analytical development, technical transfer and production, production of clinical pilot batches for all clinical phases according to FDA and ICH, etc. hameln pharmaceuticals gmbh regulatory affairs services include: Implementation of national and international approval processes for drugs and medical products around the globe, Creation of complete registration dossier for country-specific requirements, Compilation of chemical-pharmaceutical documentation (CMC Parts), Creation and compilation of preclinical and clinical documents and reports, Development of SmPCs under consideration of European reference products, Development of individual prescribing information, Evaluation of the relevance of dossiers, etc.

Company Services

Services/CapabilitiesCDMO

+ Development Services

Analytical Development & Validation
Bioanalytical Services
Process Development & Validation
Scale Up/Tech Transfer
Stability Testing

+ Drug Product Manufacturing

Sterile Bags Manufacturing

+ Drug Substance Manufacturing

Controlled Substances

+ Packaging

Prefilled Syringes/Cartridges/Pen Devices