Innovative/Brand Products

The post-marketing Innovative team supports pharmaceutical companies in their effort to launch and maintain new medicinal products on the market or to further expand by offering solutions and ensuring safety information is received, reviewed and analyzed. Our experts in collaboration with Regulatory Affairs and PV Network determine the applicable regulatory requirements and ensure compliance.

For instance, developing Pharmacovigilance Plans (PVP) for Advanced Therapy Medicinal Products (ATMP) is challenging and requires fine-tuning among multiple functions, since PVPs need to be reviewed at the time of licensure, but should include post-licensure long-term follow-up studies (LTFU) with limited leeway from regulators. In addition, medical assessment of ICSRs tends to be more rigorous than in other medicinal products.

Our dedicated PM team and medical experts can:

• Assist you to assemble a comprehensive PVP for ATMPs or any innovative combination products including those that utilize well-established medicines and seek to expand their indication and targeted delivery
• Co-ordinate PV activities pertinent to launching of a LTFU registry – or use an existing patient registry – to systematically capture and track data from treated patients with solicited sample collection and follow-up of AEs to resolution or stabilization to collect additional pertinent data e.g., through active surveillance
• Advise you when applicable agreements should be in place with registry owners in order to allow the use of patients’ data collected for regulatory purposes.

With a proven track record to expand and grow our services tailored to your business endeavors, PrimeVigilance’s Innovative Business Unit can function as ‘one-stop shop’. We can therefore support your post-marketing PV commitments to regulators, including early coordination and planning of enhanced PV measures, as well as oversee clinical trials; thus sharing valuable intelligence across the board.