We offer complete services to cater for the Good Distribution Practices requirements.
We offer Qualified Person and Responsible Person services on a contract basis.
We implement Pharmacovigilance systems in the EU and the Middle East.
A few words about us
Established in 2015, Quintian Pharma is the brainchild of a professional team with decades of combined experience working in and dealing with the pharmaceutical industry. Made up of a small team of carefully selected professionals, Quintian Pharma has the flexibility to tailor-build its products and solutions to the needs of its clients.
As an EU-based company located in Malta, Quintian is dedicated to providing services and support to the pharmaceutical industry, while following all EU directives on pharmaceuticals, enabling us to help our clients remain fully up-to-date on EU regulations at all times.
Being a privately-owned pharmaceutical services company, our experience and knowledge of the manufacturing and distribution aspects of pharmaceutical products make us perfectly placed and qualified to offer its clients practical solutions. All our actions and decisions are guided by our Roman Catholic values.
We offer three specific services: Quality Assurance (QA), Pharmacovigilance (PV), and Regulatory Affairs and Licensing (RA).
In addition to our services aimed at pharmaceutical companies, we are also very keen on Research and Development, and are currently developing our own products in the non-sterile liquids sector.
Our mission at Quintian Pharma is guided by our Roman Catholic values, which lay the foundation of our ethical views. We pride ourselves on placing the well-being of humankind above all in our involvement with pharmaceutical products. We believe that honesty, transparent dealings and the sanctity of human life are all equally important in showing our clients our respect towards humanity.
Our aim is also to provide pharmaceutical companies with the highest quality of services.
Whether you are intending on purchasing a raw material or a drug from a supplier or you need to qualify your client, Quintian Pharma is pleased to offer GMP (Good Manufacturing Practices) / GDP (Good Distribution Practices) Audits in the EU as well as outside Europe (including China, India and USA).
In order to comply with Directive 2001/83/EC and Commission Guideline 2013/C 343/01 we offer Qualified Person and Responsible Person services on contract basis. This is an essential service for pharmaceutical companies that would like to comply with EU regulations and remain on top of the competition.
The highly experienced team of Quintian assists pharmaceutical companies to achieve compliance in the best way for them. In addition to providing support, our QA services also include on-site audits, on the conclusion of which we craft detailed reports and the steps our clients should take in order to achieve their final goals. Quintian works closely with the clients to ensure that they reach their goals successfully within the stipulated time limits.
Once a drug is authorized on the market, companies are to provide monitoring services for their medicinal products. In order to do this, a system needs to be set up to ensure reliability and robustness for the patient trying to relay the information to the Marketing Authorisation Holder. We also ensure compliance with the requirements of the EMA and the EU competent authorities, according to EU Regulation 520/2012. This aspect is known as Pharmacovigilance and Quintian Pharma is your ideal partner to set up and implement such a system, whether in the EU or outside Europe.
Quintian Pharma employs an experienced team of Pharmacovigilance professionals, including EU-QPPV (European Union Qualified Person for Pharmacovigilance), deputy EU-QPPV, local QPPV (where required) and a Medical Doctor that are ready to assist you. We have experience in implementing Pharmacovigilance systems in the EU, as well as in other areas such as the Middle East.
We also provide GVP (Good Pharmacovigilance Practices) Audits for the assurance of the proper implementation of the Pharmacovigilance guidelines. In this capacity of ours, we will help you to obtain the necessary authorizations and ensure that your company fulfils all EU requirements and criteria. We can also assist you in building an entire Pharmacovigilance system.
Together with our business partners, we can help you build dossiers for your products in the eCTD format, both from scratch and after implementing a gap analysis on any existing dossier in order to analyze what should be altered. In addition to compiling and amending product dossiers, we can also guide you through registering your products within the EU via the National or European procedures (Mutual Recognition or Decentralised Procedures).
START-UPS IN THE PHARMA INDUSTRY
One thing we are specialists in is the set-up of new pharma companies. Be it the simple set-up of a trading entity to the establishment of a new manufacturing facility, we have the right expertise and the dedication to provide the technical background required to make the right choices at such a crucial time of the business activity.
Different companies have specific needs, and usually require different licenses. We can help you obtain the appropriate license for your activities and comply fully to Directive 2001/83/EC.
For distribution operations, we can provide the complete services to cater for the Good Distribution Practices requirements of both small and large companies as per the guidelines 2013/C 343/01 and Article 84 and Article 85b(3) of Directive 2001/83/EC.
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Get in Touch
For queries and more information please send an email to email@example.com