post-market monitoring

Patient Reported Safety and Outcomes

Product Complaint Intake and Follow-up Services

As your trusted MI partner, our highly trained staff follow established processes and guidelines for handling PQC events, to meet both regulatory reporting requirements as well as your company’s own internal quality and manufacturing standards. Our experts can conduct case follow-ups and/or provide full case processing on your company’s behalf. We are dedicated to supporting your customers and patients, beyond just satisfying regulations.

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Real World Evidence

ProPharma's team of experts support Real World Evidence (RWE) research efforts so that clients can make faster decisions and have better insight into their products and meet key stakeholder needs.

Our team takes a customized approach to RWE that assesses each client's specific needs and develops strategic solutions that support their asset leading up to commercial launch and beyond.

Labelling & Promotional Review

Compelling, Compliant Information to Successfully Promote Your Product

Any activity undertaken, organized, or sponsored by a company that is intended to promote the prescription, recommendation, supply, administration, or consumption of a pharmaceutical, biotechnology, or medical device product may be considered promotional material. Such marketing collateral can be available through various methods of communication, including ads and brochures, mailings, websites, congress materials, and presentations from spokespersons or medical representatives. This content must follow strict European Union (EU) and national guidelines relating to the promotion of medicines, such as the European Federation of Pharmaceutical Industries and Associations (EFPIA) code of practice.

During every step of the product lifecycle, your product’s messaging to healthcare professionals and patients must always be clear, compelling, and fully compliant. Whether you’re developing print materials, websites, digital sales aids, or patient support materials, ProPharma has the knowledge and experience to help ensure all of your marketing materials are balanced and aligned with all regulatory and ethical codes.

Fair Balance, Compliance, and Business Objectives

Promotional material has two equally important objectives:

(1) it must achieve business goals, and (2) it must comply with regulatory constraints. Any promotional material must always accurately present both risks and benefits, and all claims need to be truthful, substantiated, and non-misleading.
At ProPharma, our experts can ensure that you adhere to applicable laws, regulations, and industry standards while maintaining the highest ethical standards for reporting of your sales, marketing, and promotional material in the EU/European Economic Area (EEA). We can help with all aspects of creating and publishing promotional material, including:

• Regulatory review of promotional and non-promotional materials and activities in accordance with the respective ethical codes in the local country
• Creation and update of Abbreviated Product Information (API) texts
• Support in setting up a routine for local review of promotional materials in the local country
• Advice on general questions regarding the local ethical codes

Medical & Regulatory Advertising Promotional Review

ProPharma provides medical and regulatory review services with our experienced staff that are overseen and mentored by leaders who have sat in your chair:

Regulatory Review

• OPDP or APLB product advisory comment submissions –authoring, editing, and preparation
• Successful interactions with OPDP
• Guide teams through FDA regulations, guidance documents and enforcement communications
• Deep understanding of trial design and outcomes

Medical Review

Cost-effective resources to manage day-to-day review responsibilities, without sacrificing scientific accuracy or integrity.

• Promotional and Medical Review Committee participation
• Medical accuracy and evidentiary standard review (substantial evidence, competent and reliable/FTC)
• Broad therapeutic experience

Compliance Program Development & Monitoring

ProPharma helps companies develop and maintain effective compliance programs. Monitoring and Auditing Support. The compliance monitoring program at ProPharma includes:

• Field monitoring:  ride-alongs, speaker programs and other events
• Monitoring of data analytics from sales representatives, HCP interactions, and email Strategic monitoring plans such as quick start guides and plans for protocol development

Compliance Program Development

ProPharma helps small companies develop ethics and compliance programs using the Office of the Inspector General’s seven elements of an effective compliance program as a starting point and then develop programs to meet state and federal compliance requirements to avoid unwanted scrutiny, enforcement, and fines. To make that happen, we implement our proprietary four-step process:

• Perform program assessment
• Identify and document inherent compliance risks
• Compliance program development 
• Compliance monitoring and support

Regulatory Operations

ProPharma helps companies implement the correct solutions of processes, standards, systems, templates, and best practices for effective Regulatory Operations. With the right Regulatory Operations group, you can achieve high quality document management, data management, and regulatory agency submissions.

Marketing Operations

Promotional Material Review Process & Marketing Materials Management