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Further to that ACE offers manufacturing and packaging of clinical trial medication. We specialize in solid, semisolid and liquid pharmaceutical products. In a strategic alliance with other companies we can offer you parenteral formulations: ampoules, vials, lyophilised and terminally sterilized processes for single and multi-dose products, small molecules and peptides / proteins and sterility assurance / process validation. The solutions we offer are tailored to our customers' exact needs, modular services with the overriding objective of accelerating commercial success. Our expertise covers API characterization, pre-formulation, formulation development, validation and analytical method development. Our GMP-license states that ACE is authorised to manufacture and supply (worldwide) investigational medicinal products for clinical trial purposes. Our track record includes over 20 products, which have either performed development work, and/or manufactured clinical trial medication, which are now registered products.
ANALYTICAL SERVICES
Our laboratory is a certified, independently operating analytical laboratory, providing advanced and sophisticated analytical services with experienced professionals and state-of-the-art instrumentation (Certificate 103441 EL, issued by the Ministry of Health). The ACE laboratory has a strong commitment towards quality assurance and provides quality and excellence in analytical support. ACE operates cGMP guidelines and ICH-guidelines.
Analysis of active ingredients as such, in blends and finished products such as soft and hard gel caps, tablets and capsules Quantitative and qualitative characterization of impurities, residual solvents etc Assays and dissolution tests of finished products according to EP, BP, USP and JP-guidelines Analytical method validation and method development services Clinical trial analytical support Pharmaceutical equivalence studies Finished product stability studies
GMP storage facilities: at room temperature or between 2C and 8C Monitoring of temperature and humidity Worldwide distribution (to clinical centres, investigators and/or sponsors) Receipt, evaluation and reconciliation of returns Destruction of returns
PROJECT MANAGEMENT
Full project management includes randomisation of treatments, protocol development, advice and consultation worldwide; dynamic and GMP/GCP experimented staff.
QUALITY ASSURANCE
Permanent training of operators and the maintenance of our quality system have allowed us to reach an excellent level of quality and to obtain the manufacturer authorisation (license 3103A/d) issued by the Dutch Ministry of Health. This certificate is based on the application of Good Manufacturing Practices and ICH-guidelines dedicated to clinical supplies.