High-quality, low-cost cooperation

Assisting the development, registration and marketing of generic drugs in Europe is the main focus for pharmaceutical firm AqVida. The company’s managing director Wolfgang Heinze talked to World Pharmaceutical Frontiers about the added value offered to international manufacturers and local clients in the EU.

Wolfgang Heinze.

World Pharmaceutical Frontiers: Mr Heinze, your company Aqvida is specialised in the sourcing of APIs and finished dosages. How do you see the future of this business?

Wolfgang Heinze: First of all: positive. Evidently there are changes in this market. It is becoming increasingly important to position oneself with the suppliers but at the same time understanding the changing needs of our clients.

WPF: What are the clients’ needs in your opinion?

WH: One of them is the assurance of the quality of the products. Our industry is characterised by increasing regulatory requirements, cost pressure and consolidation. You are forced to produce better quality at lower costs, for a globalised market with increasing competition.

WPF: How do you think this can be achieved?

WH: We think that it is important to bundle the requirements of several clients and also of the suppliers. Manufacturers should seek to cooperate with companies like ours who are able to provide services like GMP audits. We as a European company are familiar with the highly regulated and enormous European market; and we have the resources to arrange audits, to provide regulatory support and to take over inevitable production steps like batch releases in Europe undertaken by our Qualified Person. For manufacturers outside the EU, especially from Asia, we can act as a door opener to the European market.

WPF: Where is the advantage for the customers – does this mean that European customers will have to inspect the facilities of the manufacturers?

WH: No, not at all. This is one of the functions we are taking over. We offer the customers the chance to outsource the functionality of auditing and quality assurance to us. We can provide added value to them as they do not have to send their own auditors to the manufacturers frequently. This can result in considerable cost savings and in realising economies of scale. For example, we are able to perform inspections for a client, for, let’s say, five products. We do the inspections of the five manufacturers and provide products to the clients that comply with highest regulatory requirements. At the same time it is possible to offer this product to, for example, five other clients without them having to perform further inspections. This means that instead of 25 inspections of five manufacturers by five clients for five different products, we perform only five inspections with the same result. Overall, this offers enormous costsaving opportunities to the entire industry. We assume responsibility for the manufacturer and enable them to count with an independent European audit – by our Qualified Person and the German authorities.

WPF: Do you also take over the costs?

WH: These details are decided on a case-by-case basis. The customer should consider that it opens up an enormous market to them and they will take a step forward in terms of quality and opportunities. Also, as shown by the example, the number of inspections will decrease and reduce the costs. The costs for a European audit are not as high as might be expected and we are transparent in this matter.

WPF: Who are suitable manufacturers in your opinion?

WH: Ideally the manufacturer should have an idea about EU-GMP requirements. The added value for the manufacturer is that we can import complete batches and carry out the EU release. Clients in Europe can purchase smaller quantities without having the high cost of releasing the product and we can supply this quickly. We also encourage manufacturers who are not yet able to comply with these standards. We have already supported companies from China and Argentina to achieve European certifications which has enabled them to enter the European market.

Company profile

AqVida is focusing on the registration, licensing, import and release of generic products to Europe. AqVida counts with a highly qualified multinational regulatory affairs team, conducts international audits and supports marketing and licensing to international customers.

For more information, vist: www.aqvida.com.