Why outsourcing is a worthwhile investment

Compliance must be constant

When it comes to the development, manufacture and marketing of drugs and medical devices, stringent regulations and standards must be not only met but also maintained.

With lives and wellbeing at stake, it is not surprising to learn that, throughout the world, the pharmaceutical industry is heavily regulated and subject to evolving compliance measures that can vary dramatically from region to region. These require extensive knowledge not only of the product but also of the intricate nuances behind the specific regulatory requirements.

For many, this can be complex, time intensive and very expensive. While some may well be equipped to navigate this essential part of the process, there are numerous reasons why it makes sense to entrust and outsource this Regulatory Affairs function to seasoned, external professionals.

The Regulatory Affairs role

One of the key functions of Regulatory Affairs is to ensure that new drugs and medical devices are approved for sale by regulatory agencies such as the U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMA).

This process involves submitting extensive documentation and data to the regulatory agency, which can take many months or even years.

Another important function of Regulatory Affairs is guaranteeing that the company's products are properly labeled and packaged and that the necessary warnings and precautions are included.

This is critical in ensuring the safety of the patients using the products and in protecting the company against potential lawsuits.

What G&L does

With responsibility for ensuring medical products meet the strict and ever-changing regulatory requirements of the countries in which they are marketed, G&L’s Regulatory Affairs experts play an essential role in the process.

Working throughout the world, our unrivaled knowledge of local markets, combined with our global support network, ensures our clients’ products always meet the specific regulatory requirements of the countries in which they are marketed.

This is achieved through the establishment and nurturing of excellent working relationships with Health Authorities. Our Regulatory Affairs experts work closely with other key departments, such as research and development, manufacturing, and clinical, to ensure that all aspects of product development and marketing are compliant with regulations.

Our teams also play a central role in post-approval activities, such as monitoring the safety of the product once it is on the market and ensuring that all necessary changes to the product or its labeling are made promptly.

They also take responsibility for ensuring that the company's products follow good manufacturing practices, and that accurate records and documentation are always maintained.

Outsourcing works

Pharmaceutical regulations never stand still and are becoming increasingly stringent.

From the point of view of patient safety, this can only be a good thing.

However, for many companies, keeping up to speed with constant change and regional variations can place enormous, unnecessary strain on their precious resources.

From financial and legislative perspectives, outsourcing makes sense.

G&L’s commitment to working with only the best global talent means we provide comprehensive regulatory insights to all our clients and ensure we provide the right person for their specific needs every time.

Utilizing our experts removes the uncertainty of the hiring process as G&L’s specialists seamlessly integrate into existing teams, bringing with them decades of experience and making sure all requirements are met in all phases of drug and device development.

We believe that investing in outsourcing adds real value. By benefitting from G&L’s support, our clients are better equipped to bring their products to market quickly and efficiently and to maintain compliance with regulatory requirements over the life cycle of the product.

Lakshmi Thunuguntla is a Regulatory Affairs Manager at G&L Healthcare Advisors

Related: Why regulatory consultancy makes sense