Services

At Emona Labs we offer a broad spectrum of testing, release, analytical methods know-how, vendor qualification, and importation.

Batch testing and release

In accordance with EU regulations, pharmaceuticals made outside of the EU, or countries with which the EU has mutual recognition arrangements in place (USA, Canada, Australia, New Zealand, Israel, Japan, and Switzerland) require quality control tests by a GMP-certified laboratory situated in the EU before selling the products on the European market.

This mandated testing, coupled with reviews of associated batch manufacturing and quality documents by an EU-based Qualified Person (QP) is the first step before the distribution of products within the EU.

Both finished and investigational medicinal products from non-EU countries are subjected to this rule.

Testing of various pharmaceutical forms

Under cGMP conditions we can test:

Oral solids: tablets, hard capsules, soft capsules.
Oral liquids: syrups, oral solutions, drops.
Potent products.
Sterile products.

Method development and transfer

We provide consultation, analytical method development, validation protocol design.

We assist with transferring in or out the analytical methods for your products.

Vendor qualification and auditing

Our Qualified Person can perform audits and qualifications of your API manufacturers, excipient suppliers and other partners responsible for making, transporting and distributing your products.

Importation

We offer the importation of the samples and of commercial batches into the EU and their storage prior to the release under cGMP conditions.