Regulatory Intelligence

Regulatory intelligence helps organizations stay compliant and ahead of evolving drug safety requirements.

Role of Regulatory Intelligence

Regulatory Intelligence relates to the gathering, analyzing, and application of knowledge about regulatory updates to the ever-evolving requirements and guidelines relating to drug safety. Maintaining up- to- date knowledge of Regulatory Intelligence ensures that CROs and Pharmaceutical companies remain compliant with current reporting responsibilities, as well as surveillance requirements and risk management.

Regulatory Intelligence has many practical applications, including:

  • Regulatory Compliance
  • Drug Safety Monitoring
  • Market expansion
  • Crisis and/or Risk Management
  • Regulatory Audits and Inspections
  • Facilitating Market Access
Business worker holding espresso cup and stack of papers looking forward
Several business professionals having fun at a business meeting

Regulatory Intelligence at ProPharma

Regulatory Intelligence is a key pillar at ProPharma, and aims to simplify compliance, reduce risks, and ensure both ProPharma and our clients stay ahead of any regulatory changes. We achieve this by utilising various Regulatory Intelligence tools, Artificial Intelligence, completing monthly manual reviews of authority websites, as well as having a vast network of local knowledge to collect and evaluate local and global regulations.

The thorough analysis of any findings from each of these sources allows for an up-to-date Regulatory Intelligence Repository that colleagues can access to easily answer queries either internally or from clients. Where the answer isn’t already available, ProPharma has the ability to provide fast turnaround responses to ad-hoc requests for Regulatory Intelligence, going as far as offering one- to- one Regulatory Intelligence consultations.

Having access to the most up-to-date global regulation requirements, and the knowledge to interpret these regulations accurately, makes ProPharma completely qualified to perform submissions all over the world. This applies to periodic and expedited submissions, as well as Post-Marketing and Clinical Aggregate Report submissions, and EU product registration and updates in XEVMPD.

Our top priority at ProPharma is regulatory compliance, ensuring that all submissions are performed in accordance with applicable regulations. Due to our Regulatory Intelligence repository and expert interpretations of requirements, ProPharma is proud to consistently post a greater than 99% compliance rate for regulatory submissions, successfully submitting over 2,000 ICSRs per month to health authorities and ethics committees, and distributing reports on-time to investigators and business partners on behalf of our clients.

For clients utilizing our PV submission services, we offer access to the relevant RI for no additional cost, and for clients not utilizing our submissions services, we offer subscriptions to our PV RI information and updates. This information is provided in three different options that build upon each other, allowing the use of a single format or combination of formats. When you have needs, we have answers. Let us know how we can support you today.

Business professionals discussing data around a conference table

Regulatory Intelligence  Services

Stay ahead of regulatory changes with ProPharma's expert regulatory intelligence services. Contact us today to learn how we can support your compliance needs.

News & Insights

Pros and Cons of Working with a CRO

July 31, 2025

Pros and Cons of Working with a CRO

Explore the pros and cons of working with a Contract Research Organization (CRO) and how ProPharma sets a new standard in clinical development success.

Understanding PADER: A Key Pharmacovigilance Requirement for the U.S. Market

July 28, 2025

Understanding PADER: A Key Pharmacovigilance Requirement for the U.S. Market

Learn about PADER, a crucial pharmacovigilance requirement for U.S. drug safety monitoring, and how it differs from PSUR in ensuring compliance and patient safety. Summarizing the main point of the...

Understanding the Roles of LPPV, QPPV, and the PSMF in Pharmacovigilance: A Guide for Marketing Authorization Holders (MAHs)

July 25, 2025

Understanding the Roles of LPPV, QPPV, and the PSMF in Pharmacovigilance: A Guid...

Learn about the crucial roles of QPPV, LPPV, and PSMF in ensuring effective pharmacovigilance and regulatory compliance for Marketing Authorization Holders (MAHs).

ProPharma Appoints Marshall Florence, Former FDA Labeling Expert, as Vice President, Labeling & Strategy to Advance Strategic Labeling & Promotional Review

July 8, 2025

ProPharma Appoints Marshall Florence, Former FDA Labeling Expert, as Vice Presid...

ProPharma appoints former FDA labeling expert as VP, Labeling & Strategy, enhancing strategic labeling, promotional review, and regulatory consulting expertise to accelerate drug development and...

ProPharma Recognized for AI Excellence at ECCCSA

January 31, 2025

ProPharma Recognized for AI Excellence at ECCCSA

ProPharma wins Silver at ECCCSA for AI innovation in Medical Information, enhancing efficiency and quality in delivering accurate medical information.

ProPharma Appoints Brian Tuttle as Chief Financial Officer

October 21, 2024

ProPharma Appoints Brian Tuttle as Chief Financial Officer

ProPharma appoints Brian Tuttle as CFO to drive financial strategy and accelerate global growth, leveraging his 20 years of life sciences industry experience.

ProPharma Recognized for AI Excellence at ECCCSA

January 31, 2025

ProPharma Recognized for AI Excellence at ECCCSA

ProPharma wins Silver at ECCCSA for AI innovation in Medical Information, enhancing efficiency and quality in delivering accurate medical information.

ProPharma Receives 2024 CPHI Regulatory and Compliance Award

October 9, 2024

ProPharma Receives 2024 CPHI Regulatory and Compliance Award

ProPharma wins CPHI Pharma Award for excellence in regulatory and compliance innovation, enhancing efficiency and accelerating market access for life-saving therapies.

ProPharma Honored in the 2024 Clinical Trials Excellence Awards

September 24, 2024

ProPharma Honored in the 2024 Clinical Trials Excellence Awards

ProPharma honored with Clinical Trials Excellence Award 2024, recognizing their outstanding contributions in the pharmaceutical industry.

Case Study Successfully Executing a Tech Transfer in a Week - ProPharma

July 29, 2025

Successfully Executing a Tech Transfer in a Week

Discover how ProPharma supported a $3B pharmaceutical tech transfer that was executed in just 3 days, relocating five complex product lines. The plan included FDA alignment, pre-approved protocols,...

Case Study Obesity – Accelerated Timelines - ProPharma

July 29, 2025

Obesity – Accelerated Timelines

A mid-size biotech needed fast U.S. market entry for an obesity trial. ProPharma activated 20 sites in 30 days and enrolled 300+ patients—meeting goals despite an increased sample size. Strategic...

Whitepapers Key Compliance Challenges in U.S. Medical Information Services - ProPharma

July 29, 2025

Key Compliance Challenges in U.S. Medical Information Services

For Medical Information (MI) teams navigating today’s evolving regulatory landscape, compliance isn’t just a requirement — it’s a strategic imperative. From managing off-label inquiries to...

Avoiding Common Pitfalls During FDA Inspections

July 29, 2025

Avoiding Common Pitfalls During FDA Inspections

Starting August 2025, the FDA will conduct unannounced inspections at non-U.S. sites. This webinar explores common inspection pitfalls and how to maintain global inspection readiness with expert...

Inside FDA Review: Crafting a Quality ANDA Labeling Submission

July 22, 2025

Inside FDA Review: Crafting a Quality ANDA Labeling Submission

Gain rare, insider insight into the FDA’s expectations for ANDA submissions in this session led by Marshall Florence, PharmD, a former FDA reviewer who recently joined our team. With firsthand...

MAH Essentials: Ensuring Compliance for European Market Entry

July 10, 2025

MAH Essentials: Ensuring Compliance for European Market Entry

This webinar covers the key responsibilities of Marketing Authorization Applicants/Holders and Qualified Persons in the EEA/UK, including pharmacovigilance requirements, legal entity setup, and...

News & Insights

Pros and Cons of Working with a CRO

July 31, 2025

Pros and Cons of Working with a CRO

Explore the pros and cons of working with a Contract Research Organization (CRO) and how ProPharma sets a new standard in clinical development success.

Understanding PADER: A Key Pharmacovigilance Requirement for the U.S. Market

July 28, 2025

Understanding PADER: A Key Pharmacovigilance Requirement for the U.S. Market

Learn about PADER, a crucial pharmacovigilance requirement for U.S. drug safety monitoring, and how it differs from PSUR in ensuring compliance and patient safety. Summarizing the main point of the...

Understanding the Roles of LPPV, QPPV, and the PSMF in Pharmacovigilance: A Guide for Marketing Authorization Holders (MAHs)

July 25, 2025

Understanding the Roles of LPPV, QPPV, and the PSMF in Pharmacovigilance: A Guid...

Learn about the crucial roles of QPPV, LPPV, and PSMF in ensuring effective pharmacovigilance and regulatory compliance for Marketing Authorization Holders (MAHs).

Previous Post Arrow Next Post Arrow
ProPharma Appoints Marshall Florence, Former FDA Labeling Expert, as Vice President, Labeling & Strategy to Advance Strategic Labeling & Promotional Review

July 8, 2025

ProPharma Appoints Marshall Florence, Former FDA Labeling Expert, as Vice Presid...

ProPharma appoints former FDA labeling expert as VP, Labeling & Strategy, enhancing strategic labeling, promotional review, and regulatory consulting expertise to accelerate drug development and...

ProPharma Recognized for AI Excellence at ECCCSA

January 31, 2025

ProPharma Recognized for AI Excellence at ECCCSA

ProPharma wins Silver at ECCCSA for AI innovation in Medical Information, enhancing efficiency and quality in delivering accurate medical information.

ProPharma Appoints Brian Tuttle as Chief Financial Officer

October 21, 2024

ProPharma Appoints Brian Tuttle as Chief Financial Officer

ProPharma appoints Brian Tuttle as CFO to drive financial strategy and accelerate global growth, leveraging his 20 years of life sciences industry experience.

Previous Post Arrow Next Post Arrow
ProPharma Recognized for AI Excellence at ECCCSA

January 31, 2025

ProPharma Recognized for AI Excellence at ECCCSA

ProPharma wins Silver at ECCCSA for AI innovation in Medical Information, enhancing efficiency and quality in delivering accurate medical information.

ProPharma Receives 2024 CPHI Regulatory and Compliance Award

October 9, 2024

ProPharma Receives 2024 CPHI Regulatory and Compliance Award

ProPharma wins CPHI Pharma Award for excellence in regulatory and compliance innovation, enhancing efficiency and accelerating market access for life-saving therapies.

ProPharma Honored in the 2024 Clinical Trials Excellence Awards

September 24, 2024

ProPharma Honored in the 2024 Clinical Trials Excellence Awards

ProPharma honored with Clinical Trials Excellence Award 2024, recognizing their outstanding contributions in the pharmaceutical industry.

Previous Award Arrow Next Award Arrow
Case Study Successfully Executing a Tech Transfer in a Week - ProPharma

July 29, 2025

Successfully Executing a Tech Transfer in a Week

Discover how ProPharma supported a $3B pharmaceutical tech transfer that was executed in just 3 days, relocating five complex product lines. The plan included FDA alignment, pre-approved protocols,...

Case Study Obesity – Accelerated Timelines - ProPharma

July 29, 2025

Obesity – Accelerated Timelines

A mid-size biotech needed fast U.S. market entry for an obesity trial. ProPharma activated 20 sites in 30 days and enrolled 300+ patients—meeting goals despite an increased sample size. Strategic...

Whitepapers Key Compliance Challenges in U.S. Medical Information Services - ProPharma

July 29, 2025

Key Compliance Challenges in U.S. Medical Information Services

For Medical Information (MI) teams navigating today’s evolving regulatory landscape, compliance isn’t just a requirement — it’s a strategic imperative. From managing off-label inquiries to...

Previous Resource Arrow Next Resource Arrow
Avoiding Common Pitfalls During FDA Inspections

July 29, 2025

Avoiding Common Pitfalls During FDA Inspections

Starting August 2025, the FDA will conduct unannounced inspections at non-U.S. sites. This webinar explores common inspection pitfalls and how to maintain global inspection readiness with expert...

Inside FDA Review: Crafting a Quality ANDA Labeling Submission

July 22, 2025

Inside FDA Review: Crafting a Quality ANDA Labeling Submission

Gain rare, insider insight into the FDA’s expectations for ANDA submissions in this session led by Marshall Florence, PharmD, a former FDA reviewer who recently joined our team. With firsthand...

MAH Essentials: Ensuring Compliance for European Market Entry

July 10, 2025

MAH Essentials: Ensuring Compliance for European Market Entry

This webinar covers the key responsibilities of Marketing Authorization Applicants/Holders and Qualified Persons in the EEA/UK, including pharmacovigilance requirements, legal entity setup, and...

Previous Webinar Arrow Next Webinar Arrow