OUR

SERVICES

Qualified Person (QP) Services and Batch Release

Medelligent Pharmaceuticals Ltd (Medelligent) undertakes the certification and release of batches manufactured in the EU and/or in third countries. Our highly experienced Qualified Persons (QPs) cover non-sterile and sterile Finished Dosage Forms (FDFs) as well as starting materials including Active Pharmaceutical Ingredients (APIs). Access to EU-based laboratories which can undertake the testing of FDFs imported in the EU is also provided. Our QPs can undertake to establish Manufacturing/Import Authorization (MIA) as well as Wholesale Distribution Authorization (WDA) complying with EU Good manufacturing Practices (GMP). Consultancy can be offered on QP release challenges.

GMP Audits of API and FDF Manufacturers

Medelligent Pharmaceuticals Ltd (Medelligent) undertakes the certification and release of batches manufactured in the EU and/or in third countries. Our highly experienced Qualified Persons (QPs) cover non-sterile and sterile Finished Dosage Forms (FDFs) as well as starting materials including Active Pharmaceutical Ingredients (APIs). Access to EU-based laboratories which can undertake the testing of FDFs imported in the EU is also provided. Our QPs can undertake to establish Manufacturing/Import Authorization (MIA) as well as Wholesale Distribution Authorization (WDA) complying with EU Good manufacturing Practices (GMP). Consultancy can be offered on QP release challenges.

Quality Management Systems

Medelligent Pharmaceuticals Ltd (Medelligent) undertakes the certification and release of batches manufactured in the EU and/or in third countries. Our highly experienced Qualified Persons (QPs) cover non-sterile and sterile Finished Dosage Forms (FDFs) as well as starting materials including Active Pharmaceutical Ingredients (APIs). Access to EU-based laboratories which can undertake the testing of FDFs imported in the EU is also provided. Our QPs can undertake to establish Manufacturing/Import Authorization (MIA) as well as Wholesale Distribution Authorization (WDA) complying with EU Good manufacturing Practices (GMP). Consultancy can be offered on QP release challenges.

Plant Layout Materials and Machinery Selection

Medelligent Pharmaceuticals Ltd (Medelligent) undertakes the certification and release of batches manufactured in the EU and/or in third countries. Our highly experienced Qualified Persons (QPs) cover non-sterile and sterile Finished Dosage Forms (FDFs) as well as starting materials including Active Pharmaceutical Ingredients (APIs). Access to EU-based laboratories which can undertake the testing of FDFs imported in the EU is also provided. Our QPs can undertake to establish Manufacturing/Import Authorization (MIA) as well as Wholesale Distribution Authorization (WDA) complying with EU Good manufacturing Practices (GMP). Consultancy can be offered on QP release challenges.

Project Management

Medelligent Pharmaceuticals Ltd (Medelligent) undertakes the certification and release of batches manufactured in the EU and/or in third countries. Our highly experienced Qualified Persons (QPs) cover non-sterile and sterile Finished Dosage Forms (FDFs) as well as starting materials including Active Pharmaceutical Ingredients (APIs). Access to EU-based laboratories which can undertake the testing of FDFs imported in the EU is also provided. Our QPs can undertake to establish Manufacturing/Import Authorization (MIA) as well as Wholesale Distribution Authorization (WDA) complying with EU Good manufacturing Practices (GMP). Consultancy can be offered on QP release challenges.

Questions?

If you have any questions, please don’t hesitate to contact us via the contact form. We will do our best to get back to you within 24 hours. If you prefer to talk to us, please let is know in the contact form and we can arrange  a call back.

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