Our comprehensive development activities includes early stage formulation and analytical development, technology transfer, scale-up, process validation and stability testing, CRO selection and clinical study design.

Our in-house experts are uniquely qualified in the field of Chemistry, Manufacturing & Controls (CMC). Our skilled staff comprises from scientists with the in-depth experience they need to ensure the robustness of their CMC capabilities.

At PharOS we offer new opportunities and growth potential to our partners by offering the right partnership model to expand business. Our experienced managers continuously seek, process and offer tailor-made partnerships on products and markets.

All our recommendations are based on solid research, cross-disciplinary expertise and a broad network of professionals located in strategic geographical positions, bringing together companies to maximize both parties’ Return on Investment (RoI).

We liaise between diverse companies with common interests to negotiate and conclude deals both on a licensing-in as well as on a licensing-out model.

At PharOS we provide Contract Manufacturing services for our site in Malta for the following categories:

• Technology Transfer of customer’s finished products
• Technology Transfer of customer’s products with dossier under development
• Stability services
• Batch Control and Release services

Our facilities are cGMP compliant for the manufacture of the conventional and oncology medicinal products (tablets and Hard capsules).

We have a variety of manufacturing equipment to handle several batch sizes.

Our packaging machines consist of fully automated packaging lines (primary, secondary, serialization, aggregation-including check weighing) for tablets and hard capsules in hot and cold forming materials and a Semi-automated line for filling, labelling and secondary packaging of the bottles.

PharOS as a CMO provides End-to-End Support during the entire manufacturing process with:

• • • Manufacturing Flexibility.
    • High technical machine design know-how.
    • Testing and release of API, excipients and final product.
    • Stability testing according to ICH guidelines in state-of-the-art climatic chambers with continuous monitoring.
    • Regular meetings with a dedicated team for monitoring the progress of the agreed steps.

Our experts’ integrated background and up-to-date regulatory knowledge make us your number 1 choice for the complete regulatory activities range: from MAAs and renewal submissions and all types of Post-Marketing Applications, to the development of global regulatory strategies.

We are a founding member of EuDRAcon®, a pan-European network of regulatory affairs companies, which further allows us to manage national applications across geographical Europe.

PharOS is able to collaborate with partners to meet the increasingly complex regulatory requirements in pharmacovigilance. Our full range of services offers flexible technologies, resourcing solutions, effective governance and continuous process improvement from early clinical development to marketed product support.

We provide full and comprehensive customer support, at all phases of the product life cycle. We create value across all areas of pharmacovigilance.

Pharos has acquired a Certificate of GMP compliance from National Organization for Medicines for batch release of sterile and non-sterile products, as well as for imported medicinal products.

The Pharos team with its extensive experience offers to its clients batch release of their products.

Our Supply Chain Management department’s expertise and professionalism are key to our track record of First to Market launches worldwide, while at the same time meeting the stringent pharmaceutical supply chain requirements