Regulatory Outsourcing

The pharmaceutical industry is currently facing a challenging period in its evolution, with traditional approaches to drug development constantly expanding. On one hand, there is tremendous pressure on the industry to reduce the cost of drugs, and on the other hand, operational costs are skyrocketing. Additionally, complex regulatory requirements, declining revenues from lost sales or delays in regulatory approvals, and pressure from governments to reduce healthcare costs further compound the difficulties.

Given these challenges, pharmaceutical companies worldwide have realized the need to leverage resources and expertise provided by specialist external sources. In the last ten to fifteen years, many large pharmaceutical companies have outsourced almost all processes, including Chemistry, Clinical, Non-Clinical, Logistics, and Marketing, as well as other non-core processes.

While outsourcing provides cost and business benefits, companies were cautious in outsourcing some functions, such as Regulatory Affairs, as they are vital functions that drive R&D efforts of the company to the market successfully. However, with companies expanding into global markets and changing clinical landscapes, most have tested unknown destinations, reducing overall costs.

Pharmaceutical companies have realized that the key to success lies in obtaining timely marketing/clinical approvals from regulators. As a result, companies have either strengthened their regulatory departments or outsourced them to regulatory affairs consulting firms to obtain such approvals.

Staying in compliance with existing regulations and constant changes in regulations of major markets across the globe, such as Pakistan, is becoming a daunting task for pharmaceutical companies. Staying current with developments across the globe further compounds the challenge. Amendments to existing regulations promise to further complicate the regulatory path for the industry, and as a result, the demand for outsourced regulatory expertise is rising.

RA Consultants (RAC) is one of the most significant management companies globally, providing business services to both national and multinational companies. RAC consists of elite and top-notch experts from the industry with decades of experience in their respective domains. They have proven themselves in every field by providing the best services and a 100% success rate.

As RAC steps into a new year of business and because of the high demand for services, they are introducing Regulatory Outsourcing to better cater to companies’ needs and improve quality further. As stated above, outsourcing is a cost-effective way of doing business, cutting down the cost of running a whole regulatory department.