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With our experienced staff from Singapore and the support from experts from our principals, Adjuvanz is ready to support your pharmaceutical factory from its beginning throughout the lifetime of your plant.
From basic design studies up to preventive maintenance and calibration schemes.
Expertise you can rely on ... honestly !
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European PIC(s) formulation and registration support of all pharmaceutical products such as solid, liquid and injectable forms, up scaling and validation of processes
Development of analytical methods including in-use stability (CPMP/ICH and CTD Module 3)
Support in regulatory affairs for european GMP s , development of nutrition supplement products, synthesis of drug substances, identification of degradation products in drug products and drug substances
Synthesis of special radioactive compounds and quality control of starting material, packaging material, intermediate, bulk and finished products.
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Room layouts based on experience of hundreds of supplied systems, including the space - saving implementation of the production equipment and the technical rooms. Also considering the optimum material and personnel movements in and out of the white areas. Efficient separation of this two recourses is a prerequisite to avoid future approval problems due to potential cross-contamination risks.
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Professional electrical and mechanical installation of the equipment supplied by our principals is a key component of Adjuvanz expertise. If required, made complete with the supervision by senior engineers send from our principals, especially for systems commissioning, process optimisation and training of your operating and maintenance crew.
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Validation assistance, also providing the necessary on-site Installation Qualification or Operational Qualification of the systems installed. In addition to this, Adjuvanz can also provide assistance for your Performance Qualification, either from own recourses of from our engineering cooperation partners from Asia or Europe.
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Even if the equipment supplied by our principals is well known to operate reliably for years, Adjuvanz provides preventive and breakdown maintenance one can count on... It goes without saying that you can contract all your maintenance to the experienced mechanics and controls experts available at Adjuvanz. In our workshop we are able to perform, to a certain extend, also on-the-spot repair and machining of broken-parts.
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