Elara Pharmaservices has a team with extensive professional experience working for pharmaceutical companies in a global environment.
We use this knowledge and experience to import products into the EEA on behalf of our clients meeting the exacting requirements in a highly-regulated industry.
The core team are skilled, dedicated professionals with a wealth of experience in:
- Pharmaceutical Manufacture including all major dosage forms
- Quality Assurance
- Quality Control
- Good Distribution Practice
- Auditing both European and 3rd country sites.
We can guide you through the process of importation of medicines from across the globe.
We are passionate and committed in what we do and excel in working with our clients, using proven methods and techniques.
Through our group companies we can also provide extensive regulatory and pharmacovigilance services including:
- Preparation and submission of regulatory dossiers
- Complete Pharmacovigilance Services including QPPV appointment
Please see our “Partners” page for more details.
Elara Pharmaservices Europe with the support of our sister companies Elara Pharmaservices UK & Callisto Consulting can assist you in: Importation of batches into the EEA under our MIA. ... [Read More]
Elara Pharmaservices Europe with the support of our sister company Callisto Consulting can assist you with Human, Veterinary and Herbal medicines in: Preparation of regulatory dossiers for the UK, ... [Read More]
Elara Pharmaservices Europe with the support of our sister company Callisto Consulting can assist you in: Medical device support internationally including the EU and US markets. Preparation of technical ... [Read More]
Elara Pharmaservices Europe with the support of our sister company Callisto Consulting can assist you in: Setting up quality systems to fulfil Marketing Authorisation Holders Pharmacovigilance obligations. Weekly literature ... [Read More]
We bring hands on practical knowledge in a wide range of dosage forms including: Tablets. Powders. Liquids. Creams. Transdermal patches. Steriles. Investigational Medicinal Products. Herbal products. Advanced therapy medicinal ... [Read More]
Importation & Batch Release
Medicinal products imported into the European Economic Area (EEA) from third countries have to be certified by a Qualified Person (QP) to be released into the market. Companies based ... [Read More]
From our in house team we can also provide: Initial Supplier review and assessment. Ongoing vendor management of the entire supply chain: API audits and certification. Raw material and ... [Read More]
At Elara Pharmaservices we have used our experience and knowledge to build a Pharmaceutical Quality System that ensures all products we certify meet the requirements expected in our industry. ... [Read More]