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Building regulatory roadmaps to ease your way through development.  

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Regulatory compliance solutions 

Our aim is to help your business succeed by working to streamline the pharma regulatory process. ProPharma’s experienced regulatory consulting and FDA compliance team commands an unparalleled breadth and depth of knowledge pertaining to the FDA and EMA regulatory frameworks and can work with you to accomplish your business objectives.

Our regulatory consultants develop detailed strategies for your product, providing a clear path forward through all the critical milestones to achieve a successful outcome. We can also help with your post-authorization regulatory pharma needs, including the launch of your product, line extensions (LE) and variations, and maintaining your products’ optimal regulatory status throughout its lifecycle.

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Health Authority Review

Our veteran regulatory sciences team has over 30 years of experience using scientific knowledge to strategize viable and efficient drug and device development pathways to achieve successful outcomes with regulatory agencies in the US and Europe. Explore all the ways that ProPharma can support your pharmaceutical regulatory affairs needs and product pipeline throughout the entire product lifecycle or speak with one of our regulatory consulting experts.

Life Cycle Management

A comprehensive scientific and regulatory strategy across all stages of the product lifecycle can help your team define a plan for long-term growth and success. After approval of your initial marketing authorization application (MAA), you need to remain compliant with all regulatory requirements (eg, post-authorization commitments, variations, renewals) to keep the product on the market. A strategic approach to lifecycle management is also valuable to maximize the potential of the product, potentially through line extensions or additional indications.

Acting as an extension of your team, ProPharma’s expert regulatory consultants bring a deep understanding of effective lifecycle management and have the knowledge to offer a complete regulatory solution for your product when marketed in the European Union (EU)/European Economic Area (EEA). We can partner with your team to provide:

  • Regulatory advice
  • Health authority liaison services
  • Variation applications, line extensions, and renewals
  • Support for post-authorization commitments
  • Product information (PI) updates/translations
  • Artwork reviews
  • Management of catalog texts and local regulatory databases
  • Readability testing

Talk with an Expert

Line Extensions (LE) and Variations

Acquiring marketing authorization for a new medicinal product is an achievement in its own right but is often only the first of many benchmarks in the life of the product. Line extensions (LE) made possible through new indications, added formulations, and expanded drug delivery mechanisms are some of the ways an initial product can evolve to extend patent exclusivity and reach new markets, while helping to improve the health and safety of more patients. Looking ahead at LE opportunities while maintaining consistency in the quality and manufacturing processes of an in-market product is a complex challenge faced by many marketing authorization holders (MAHs).

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Whether you are preparing for an LE or evaluating a potential variation to your product’s chemistry, manufacturing, and controls (CMC) process, ProPharma can help you successfully navigate the clinical, operational, and documentation aspects of the variation. We can work as an extension of your team or take care of the entire package, partnering with you to help maintain compliance throughout every change by:

  • Developing a regulatory strategy for extending your product line or lifecycle
  • Advising on regulatory requirements for variations and acting as project manager for the process
  • Compiling, writing, preparing, and publishing the submission
  • Serving as the primary point of contact with national and local health authorities

License Renewal

Throughout the product’s lifecycle, MAHs have an obligation to ensure the PI reflects current scientific data, the product safety information remains up to date, and the benefit-risk balance is still positive. Health authorities have strict legislative procedures for license renewal assessments and often require additional data or documentation, which may create challenges for your company. Having the appropriate resources to act quickly and efficiently is critical, as any misstep could have negative implications for your product’s license.

At ProPharma, our experts have a deep understanding of the science behind your product and are equally knowledgeable about the regulatory process and the expectations of the regulators. As an extension of your team, we can help you with every aspect of the license renewal process by:

  • Managing timelines and documentation throughout the process, including submissions
  • Preparing and submitting the renewal package
  • Managing responses and communication with the European Medicines Agency (EMA) or local authorizing agencies as they arise

License Renewal

Product Information

To ensure regulatory compliance, product information — including the summary of product characteristics, labeling, and package leaflet — must apply strict criteria and follow guidelines mandated by relevant filing procedures (ie, centralized, decentralized, national, or mutual recognition). Product information (PI) documents need to be accurate in multiple languages, requiring applicants to have a thorough understanding of local and national processes and the ability to translate documentation, standard statements, and terms to various European languages, including Icelandic and Norwegian.

At ProPharma, we understand the science behind your product and have a deep understanding of PI expectations from the EMA and national authorities. Throughout the application and post-authorization processes, our experts provide a wide range of PI services, including:

Core Data Sheet including safety information and materials relating to indications, dosing, and pharmacology. Our experts help develop the Core Data Sheet, and make sure all regulatory requirements and timelines are met
  • Local labels/harmonization text to harmonize national provisions so labeling is consistent throughout the EU marketplace.
  • We understand the specific requirements of local health authorities and can assist with preparing and submitting all supporting documents
  • Translations from English to various national languages within the EU. We help manage translations and assist in handling linguistic reviews to ensure accuracy for packaging, labeling, package leaflets, and artwork
  • Implementation of PI changes to ensure all changes, including new adverse events or expanded indications, are up to date and compliant with all applicable regulations and requirements. We prepare and submit all supporting documents and can assist with ongoing maintenance and updates of PI changes based on EU and local regulatory requirements

 

Patient Testing

 

Patient Information Leaflet (PIL) Testing

Patient Information Leaflet (PIL) readability testing is a legislative requirement for all medicines in Europe.

All medicines are required by European and UK law to be accompanied by a PIL setting out comprehensive information which is accessible to and understandable by those who receive it, so that they can use their medicine safely and appropriately.

ProPharma offers a comprehensive PIL readability solution from new studies to bridging reports.

Health Authority Interaction

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At ProPharma, our regulatory experts are scientists with a deep understanding of the intricacies of regulatory operations. Our veteran regulatory sciences team has over 30 years of experience using scientific knowledge to strategize viable and efficient drug and device development pathways to achieve successful outcomes with regulatory agencies in the US and Europe. 

Explore all the ways that ProPharma can support your pharmaceutical regulatory affairs needs and product pipeline throughout the entire product lifecycle or speak with one of our regulatory consulting experts.

Explore Our Services

Regulatory Strategy

As the global leader in regulatory consulting, ProPharma is able to develop a complete strategy that will give you confidence in the forecast of key milestones, necessary documentation, overall effort, cost, and plan of action. A sound strategy is a crucial component to success, as it provides input into all drug development efforts.

Regulatory Strategy Consulting Experts

ProPharma will work with you to develop an appropriate and effective strategy to get your product to market. Our team of experts will combine knowledge of your product with years of experience (including pre-clinical, clinical, chemistry, manufacturing, and controls (CMC), drug safety, and pharmacokinetics) and literature research on your product and similar approvals. The final regulatory strategy for your product will balance risk, speed to approval, and cost to provide you with a description of the most appropriate regulatory path and explain why this path is the rational choice.

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Global Quality & Compliance

ProPharma specializes in solving complex challenges.  Our experienced consulting professionals will seamlessly integrate with your team to do more than simply identify potential risks. We provide recommendations to mitigate those risks and will work side-by-side with you to implement improvement plans and collaborate with your team in addressing those risks.

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From early concept development through each clinical phase, product launch, and commercialization, our Quality and Compliance Consultants partner with clients around the world to help ensure regulatory expectations are met, business goals are achieved, and patient health and safety is assured and improved.  We do this with an unwavering focus on delivering the highest quality services through our diverse team of qualified subject matter experts. Having working experiences from large international corporations to small research companies as well as authorities such as FDA, EMA, MHRA, and national competent authorities, our experts drive operational excellence, and provide a sincere commitment to providing high-quality services. Our ability to be nimble coupled with a passion for excellence ensures our consulting services exceed clients’ expectations.

ProPharma performs quality and compliance consulting activities in all GxP areas.  Our consultants have extensive management and operational experience in at least one GxP area (GMP, GDP, GVP, GCP, GLP, GCLP, and/or IT/CSV) and often in multiple areas of expertise.

Explore Quality & Compliance

News & Insights

FDA Releases Final ICH M13A Guidance Document

December 10, 2024

FDA Releases Final ICH M13A Guidance Document

FDA recommendations for conducting BE studies, efficiency improvements in global drug development, and how ProPharma can assist with your regulatory needs.

The Evolving Landscape of Quality Management Systems in the Life Sciences Industry

December 9, 2024

The Evolving Landscape of Quality Management Systems in the Life Sciences Industry

Discover the evolving landscape of Quality Management Systems in the life sciences industry and how to navigate modern regulatory challenges.

Pre-Approval Inspection (PAI) Readiness is Easy, Right?

December 5, 2024

Pre-Approval Inspection (PAI) Readiness is Easy, Right?

Ensure your product's success with ProPharma's expert guidance on PAI readiness, from remediation tasks to regulatory filing support.

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 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 Names Dawn Sherman Chief Executive Officer

September 30, 2024

ProPharma Names Dawn Sherman Chief Executive Officer

Dawn Sherman rejoins ProPharma as CEO, bringing nearly 30 years of industry experience to lead the regulatory, clinical, and compliance services provider.

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.

ProPharma Receives 2024 CRO Leadership Award

June 13, 2024

ProPharma Receives 2024 CRO Leadership Award

ProPharma wins 2024 CRO Leadership Award for exceeding expectations in key categories, solidifying its position as a top global research consulting organization in the life sciences industry.

Infographic The Cost of Poor Project Management - ProPharma

June 10, 2022

The Cost of Poor Project Management

Project Management isn’t for the faint of heart. There is a shockingly high rate of project failure… but on the other hand, great project management can be a key differentiator that leads a company...

Infographic Successfully Passing MHRA Inspections for Overseas Manufacturing Sites - ProPharma

August 31, 2022

Successfully Passing MHRA Inspections for Overseas Manufacturing Sites

ProPharma offers GMP and GDP compliance services from clinical development to commercial distribution of the products' lifecycle. ProPharma’s Compliance and Quality team completed the first on-site...

Infographic Navigating the Generic Drug Application and Approval Process - ProPharma

October 4, 2021

Navigating the Generic Drug Application and Approval Process

Navigating the generic drug application and approval process can be challenging. From pre-filing through post-approval, find out exactly what needs to be done for your Abbreviated New Drug...

News & Insights

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 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 Names Dawn Sherman Chief Executive Officer

September 30, 2024

ProPharma Names Dawn Sherman Chief Executive Officer

Dawn Sherman rejoins ProPharma as CEO, bringing nearly 30 years of industry experience to lead the regulatory, clinical, and compliance services provider.

Previous Post Arrow Next Post Arrow
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.

ProPharma Receives 2024 CRO Leadership Award

June 13, 2024

ProPharma Receives 2024 CRO Leadership Award

ProPharma wins 2024 CRO Leadership Award for exceeding expectations in key categories, solidifying its position as a top global research consulting organization in the life sciences industry.

Previous Award Arrow Next Award Arrow
FDA Releases Final ICH M13A Guidance Document

December 10, 2024

FDA Releases Final ICH M13A Guidance Document

FDA recommendations for conducting BE studies, efficiency improvements in global drug development, and how ProPharma can assist with your regulatory needs.

The Evolving Landscape of Quality Management Systems in the Life Sciences Industry

December 9, 2024

The Evolving Landscape of Quality Management Systems in the Life Sciences Industry

Discover the evolving landscape of Quality Management Systems in the life sciences industry and how to navigate modern regulatory challenges.

Pre-Approval Inspection (PAI) Readiness is Easy, Right?

December 5, 2024

Pre-Approval Inspection (PAI) Readiness is Easy, Right?

Ensure your product's success with ProPharma's expert guidance on PAI readiness, from remediation tasks to regulatory filing support.

Previous Post Arrow Next Post Arrow
Infographic The Cost of Poor Project Management - ProPharma

June 10, 2022

The Cost of Poor Project Management

Project Management isn’t for the faint of heart. There is a shockingly high rate of project failure… but on the other hand, great project management can be a key differentiator that leads a company...

Infographic Successfully Passing MHRA Inspections for Overseas Manufacturing Sites - ProPharma

August 31, 2022

Successfully Passing MHRA Inspections for Overseas Manufacturing Sites

ProPharma offers GMP and GDP compliance services from clinical development to commercial distribution of the products' lifecycle. ProPharma’s Compliance and Quality team completed the first on-site...

Infographic Navigating the Generic Drug Application and Approval Process - ProPharma

October 4, 2021

Navigating the Generic Drug Application and Approval Process

Navigating the generic drug application and approval process can be challenging. From pre-filing through post-approval, find out exactly what needs to be done for your Abbreviated New Drug...

Previous Resource Arrow Next Resource Arrow

Complex Needs Require Custom Solutions

ProPharma builds solutions at the intersection of innovation and flexibility. We’re here to offer a custom alternative that fits your unique needs. Standout solutions scaled to your size.