The 21st century has proved a key period for the pharmaceutical industry. Advances in drug development and the introduction of artificial intelligence (AI) have provided major breakthroughs in cancer, rare diseases, and gene therapy. In fact, the close of 2018 saw the number of FDA and EMA approvals reach a five-year high.
But with these developments often come difficulties. Like most sectors, the pharmaceutical industry has encountered hardship through a tough economic climate, and organisations are being forced to find ways to reduce costs and operate more efficiently.
Combine this financial pressure with stricter compliance regulations, increasing production costs, an ongoing need for innovation, plus competition from rival firms, and pharmaceutical manufacturers have a challenge on their hands.
How pharmaceutical consulting can help
John Johnson, vice president of NSF International, Pharmaceutical Services, works with organisations to foresee and overcome these challenges and enable sustainable long-term growth.
Established in 1944, NSF provides support across a range of areas, including authoritative pharmaceutical consulting and auditing services from ex-regulatory agency inspectors and experienced industry professionals.
John’s experience notes that transformational change takes time. Take GM Pharmaceuticals in Georgia, for example. In 2014, the company approached NSF seeking support in raising standards across its Tbilisi facility, aiming to demonstrably adhere to WHO GMP guidelines, meet EU cGMP expectations and host a GMP inspection from the European Medicines Agency.
So why was this such a dramatic change? “At the time, there were literally no other major pharma manufacturing companies in the region and no local regulatory authority responsible for submissions, inspections and enforcement,” John explains.
“What they needed was inspiration, collaboration, guidance, coaching, patience and a longer-term, supportive relationship.”
Over the years that followed, NSF has worked with GM Pharmaceuticals to provide a range of transformational support. This has included essential training, mentoring of critical position holders, reviews of training records, support to increase yield and output, as well as on-site and remote guidance on interpreting cGMP expectations.
“Being on call is crucial,” John continues. “Being available and responsive at short notice has been key, too, as life has a way of throwing up surprises at short notice. Time is never our friend in this business.”
With the help of NSF’s pharmaceutical consulting service, GM Pharmaceuticals has experienced considerable development. In four years, the company has been able to rationalise its product portfolio, improve its laboratories, refine and simplify policies, and pass a range of GMP inspections with fewer surprises and reduced GMP concerns. GM Pharmaceuticals now faces the future with more confidence and expertise in interpreting industry guidelines.
For further information on the importance of compliance in the pharmaceutical industry, visit our Compliance, Consulting and Training page.