Our "Meet the Expert" series introduces you to our team of experts around the world. This "behind the curtain" view will help you get to know who we are on a professional and personal level, and highlight how our colleagues work together on our higher purpose to improve patient health and safety throughout the complete product lifecycle.
Meet Dr. David Crome, Managing Director, Quality & Compliance UK, Ireland & India
What do you do at ProPharma? How does your role support improving the health and safety of patients?
I manage the Quality & Compliance operations in the UK, Ireland, and India at ProPharma, and act as a Subject Matter Expert to strategically support our Business Development teams and clients globally.
In an ever-changing regulatory environment, we ensure that the products that our clients develop, and manufacture retain their safety, quality, and efficacy until they are administered to the patient.
We create long term win-win partnerships between our clients and ProPharma.
What is one lesson you’ve learned in this industry that has most helped you?
Over the past forty-five years of my career the pharmaceutical industry has gone through many changes, some good and some not so good, but the principle aim from the regulators has been to learn from previous industry disasters, such as thalidomide, rofecoxib, and ranitidine, and put patient safety first, which has to be applauded.
As the pharmaceutical industry rises to the next great challenges such as personalised medicines, gene therapies and COVID, to name but to name a few, we need to ensure that we encourage today's students to enter the pharmaceutical industry and demonstrate that it can offer them a rewarding career, just as it has done for me.
What do you like best about working with clients?
During my career I have had the privilege to take some medicinal products through their whole product lifecycle. Over 40 years ago, whilst working in R&D, I formulated a number of branded sterile products, and subsequently I complied and submitted their marketing authorisation dossiers to various regulatory agencies for assessment. A few years later, having changed roles, I then manufactured the launch batches of these products. Years later in my career I QP certified commercial batches of these products, and finally I was seconded to marketing to undertake NHS tendering for them.
Following a merger and acquisition of the company some twenty years after joining them, I oversaw the transfer of the manufacturing site from England to France and Germany, and these products are still marketed globally today.
Having this overview of the whole product lifecycle enables me to better understand a client’s needs, and this allows me to help them strategically plan their way to market in a timely and cost-effective manner.
Describe the biggest challenge facing our clients/industry today. How are we addressing this?
Contract Manufacturing Organisations (CMOs) based outside the EU that only have a local market or WHO GMP certification to supply their own local and non-regulated markets, strategically often wish to enter the highly regulated EU and UK markets, and to do this need to obtain an EU/UK GMP certificate.
In order to do this, they need to trigger a GMP regulatory agency inspection. This requires them to either file their own product marketing authorisation dossier in an EU country /UK, or get someone with an approved dossier to add them as an additional manufacturing site to their marketing authorisation by undertaking a technical transfer of the product into their site. ProPharma has assisted many non-EU based CMOs to obtain EU/UK GMP certification. ProPharma have the expertise to project manage this process and the regulatory agency contacts to liaise between the dossier assessment and GMP inspection teams to expedite this process on behalf of the client.
What’s one thing you’d like for potential clients to know about ProPharma?
Our vision is to be with a client throughout their business lifecycle; to support them through the inevitable challenges they may face and celebrate their achievements with them. Our aim is to generate long-term, win-win partnerships with our clients.
I am a firm believer in lifelong learning and Darwin’s philosophy that “It is not the strongest of the species that survive, nor the most intelligent, it is the one most adaptable to change”. ProPharma’s mission is to help our clients overcome the many changes and challenges along the way to market and to ensure that their products help to improve the health and safety of patients.
