Services

Our core business is the development, production and distribution of high-quality, cost-effective Beta Lactam Penicillins, however we also offer a range of additional services that encompass both Penicillins and non penicillin products.

Our highly experienced specialists are available to provide independant services in the following areas of expertise.

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Contract Manufacturing

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Regulatory Support

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Technical Support

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European Qualified Person Batch Release

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Stability Testing to Full ICH Requirements

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Quality Control Testing

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Method and Product Development

Contract Manufacturing

With over 25 years experience Athlone has become a leading Pharmaceutical Contract Manufacturer of Penicillin’s. From development to Licence approval and finally commercial manufacture we ensure your Project is professionally managed all the way to market through technical expertise, effective communication and on-time, reliable results.

We offer a full value-added service from product development through to scale-up, validation, licence submission, technical support, commercial manufacture and packaging. We manufacture small-scale commercial batches on flexible production lines through to high volume products using tried and tested processes.

Solid Dose Products

Athlone is equipped with all the expertise necessary to supply quality solid dose formats to our customers. Our Solid Dose facilities provide manufacturing and packing for capsules and both plain and film coated tablets.

Dry Suspension Powders

Athlone is equipped with all the expertise necessary to supply quality dry powder suspension formats to our customers. Our dry powder suspension facilities provide manufacturing and packing in HDPE bottles with an option for packing in individual cartons with a PIL and spoon.

Stability

Athlone Laboratories offer stability testing to full ICH guidelines within a regulated GMP (Good Manufacturing Practice) and GLP (Good Laboratory Practice) environment.

A range of controlled environmental chambers are available at varied temperatures and relative humidity(RH);

  • 25°C + ambient relative humidity
  • 25°C + 60%RH
  • 30°C + 65%RH
  • 40°C + 75%RH

The following although not exhaustive are an example of the services provided

Appearance

Assay

Related Compounds

Dissolution

pH

Density

Moisture (Karl Fischer & LOD)

Hardness

Weight Variation

Regulatory Affairs

With over 10 years experience working with the UK (MHRA), Irish (IMB) and other European regulatory authorities the Athlone regulatory group are well positioned to offer advice and support in overcoming regulatory challenges. Our regulatory group have the added advantage of working within a manufacturing environment and have the insight to offer advice from both technical and regulatory viewpoints.

We offer regulatory support for both Penicillin and non Penicillin products

Product licence submissions within the EU and international markets

Advice on regualtory strategies

Licence updates such as variations, change of ownerships, reclassifications and product licence renewals (including PSURs compilation).

Readability Testing, bridging studies and harmonisation of Patient Information Leaflets (PILs).

Compilation of Investigational Medicinal Product Dossiers

Due diligence

QC Testing

Athlone Laboratories offer Quality Control testing for both Penicillin and non Penicillin products within a regulated GMP (Good Manufacturing Practice) and GLP (Good Laboratory Practice) environment.

Overview of Services

Method development & validation according to ICH guidelines

Updating old methods for existing products in line with current regulatory standards

Raw Material analysis

Drug substance & drug product analysis

Cleaning validation or verification

Stability testing & storage