Post-Approval and Marketed Drugs

Recent high-profile product recalls have provoked debate on the safety of post-approval and marketed drugs, leading to the introduction of new regulations that require improved safety reporting in drugs that are on the market and being used by the public. SGS works with clients to help them meet the requirements of these regulations, monitoring medicinal products during Phase IV clinical research and beyond for long-term safety and effectiveness in more extensive populations.

This is a challenge that draws on expertise from across our clinical research teams, including:

• Medical and pharmacovigilance
• Data management
• Biostatistics
• Clinical trial management
• Regulatory affairs

When you call on SGS for post-approval clinical study management, we will create a program that is shaped to meet your particular needs. Referring to our specialist consultants at every step of the process, we will create the most effective plan for ensuring product safety. Our emphasis is always on ensuring the integrity of your product – and ultimately your business reputation.

SGS has been working with clients from across the pharmaceutical, biotechnology and medical devices industries for over 35 years. During this time we have gained knowledge and experience and reshaped our services to meet changes in regulations. We are always at the forefront of discovering or adopting new ways of working to help clients prove the efficacy and safety of their products. We conduct our trials with an eye on the long-term impact of a product on the public and your business. Our expert consultants are available to discuss how we could shape a program that helps you progress through Phase IV clinical trials and beyond as quickly and smoothly as possible while maintaining your reputation for product safety and responsibility.