Interview: Keith Frendo – Plant Manager and Head Quality Control, Pharmadox, Malta

By September 13, 2018 News

Keith Frendo, plant manager and head quality control of the Maltese service provider Pharmadox, discusses how they are constantly adapting to the needs of their customers by positioning themselves as a fully comprehensive service provider to the European pharmaceutical industry.

 As plant manager and head of quality control since 2012, can you introduce both yourself and Pharmadox to our international readers?

“Currently, we are focusing on finalizing our latest infrastructural expansion which will enable the Quality control analysis and QP release of 2000 batches per month, mainly through a tenfold increase in the laboratory footprint.”

 Pharmadox is an independent EUcGMP certified service provider for the pharmaceutical industry in Europe. It is worth highlighting the fact that we are a fully independent Maltese organization, which I consider to be a strong selling point for our client base. We handle products from many different manufacturers and distributors across Europe at the same time and our impartiality is a highly appreciated feature amongst our customers. Pharmadox started its operations at the end of 2010. Back then the company was still a start-up enterprise in terms of personnel with four employees in total, but at a certain stage of our operations we realized that our clients had specific requirements in terms of the services that we were offering, most predominantly is the ever-increasing level of quality that European distributors expect from a service provider like us.

In addition to that, we realized that the turnaround time is also a distinctive competitive advantage for us to stand out. In order to pursue this objective and achieve better results, we changed our business model to one which is fully autonomous across all fronts and we started to expand to a range of services, from handling only chemical Quality Control analyses, to complex analytical tests, microbiology and sterility analyses. To date, have handled a good range of dosage forms, covering non-sterile as well as sterile formulations including complex moieties in both instances. This has put us on a different platform altogether and at the moment we are very much self-sufficient and fully autonomous across all client requirements – we can import all dosage forms, carry secondary packaging if required analyse and QP release the pharmaceutical products onto the European market. A good number of times we are the partner of choice of our clientele by default due to our versatility.

This is something we have built on and it is mainly due to the fact that we have increased our capacity significantly over the years. We are now 55 employees handling in excess of 300 batches per month. Our current clientele is looking to entrust us more and more with their products. While we are not the only laboratory in Europe, I believe that we have always excelled in our field, and this has enabled our clients to be in a position to consolidate their basket of products with Pharmadox. Currently, we are focusing on finalizing our latest infrastructural expansion which will enable the Quality control analysis and QP release of 2000 batches per month, mainly through a tenfold increase in the laboratory footprint.

Which of the services that you provide drive the most revenues?

 The bulk of our operations are directly related to our Quality control laboratory. Whenever a product gets manufactured outside the boundaries of the European Union, it needs to be imported, tested and released onto the European market and this is the main pillar of our business, accounting for approximately 90 percent of our entire operations. As an ancillary service, we also carry secondary packaging activities for the Maltese market as well as for the international market.

Can you tell us a bit about the profile of your client base?

 Most of our clients are international companies and I would say that 90 percent among them are European based. We have some manufacturers among our clients and these are based outside the EU, but it is safe to say that the majority of our clients are based in mainland Europe. We are handling in total more than 300 different products originating from manufacturing sites based in India, China, Malaysia, Taiwan, Chile and Colombia.

To what extent is the size of the Maltese business community a key advantage in liaising with stakeholders such as the government?

 I must say that we have great support from the Maltese Medicines Authority and we have a great relationship from top to bottom. Being a small community has its advantages and we have seen the benefits of this every step of the journey so far.

In terms of the Maltese pharmaceutical industry, many have highlighted the key role of the Bolar provision as well as the lack of patent registration as one of the key advantages for Malta to bring more manufacturers to the country and, overall, more investment in pharma. To what extent does this competitive advantage still remain today?

From my personal perspective, at the beginning the Bolar provision was definitely an advantage as clients were considering routing their products through Malta, perhaps, due to this very reason. Today, I would say that for us, as Pharmadox, it is not important nor relevant because the vast majority of the products that we are handling are not patent-sensitive at all. Our business model is, therefore, not based on the Bolar provision – it is rather based on providing a high-quality service in the shortest possible timeframe.

A hot topic in Malta is the current ambition to bring more cannabis-related medicine development and production to the island. What is your view on this matter?

 As a service provider, we have a number of related requests. I know that there are discussions underway amongst the Maltese authorities and I am positive they will devise a framework to regulate the products and safeguard patient health.

To what extent does your holistic service offering allow Pharmadox to be a one-stop-shop for its partners and clients?

As a case in point, if a European distributor would like to commercialize a new product, they engage a contract manufacture or one of their own sites outside the EU whose products will then have to be imported by an EUcGMP certified company based in the EU. As I mentioned in the beginning, there are a number of options in this regard but here at Pharmadox we can import the product, test it, provide secondary packaging if required and QP release it on behalf of the client (MAH) onto the EU market. This is the nature of the one-stop-shop.

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Why do multinationals specifically see you as the partner of choice?

Our company maxim is ‘your target is our deadline’ and this is for a reason. We have never made any commitment that we have not achieved or even exceeded – this is definitely one of the driving factors behind our organisation. Furthermore, with our infrastructure and the new expanded QC laboratory, I am confident we can exceed our client’s expectations further.

Pharmadox is planning to expand its operations here in Malta with plans to double the size of your workforce for example. How is this working out?

 Malta has one of the lowest unemployment rates in Europe and yet we never encountered any difficulties in recruiting personnel. Generally speaking, internally as an organisation we favour an informal and direct approach as we believe this enables the personnel to be motivated, deliver and grow together. We are building a name for ourselves locally and we are showing that Pharmadox is a great place where to work, develop and progress.

What are your objectives within the next three years?

 In the last six years, we have always doubled if not tripled the company turnover year after year. The objective for the next three years is to retain the same drive and momentum. As highlighted earlier, our focus is currently set on finalizing the infrastructural expansion by July this year and thereby creating a new and evermore improved platform through which we can be of service.