Regulatory Affairs Services

Regulatory experts at MMS are adaptive, organized, and equipped with vast regulatory knowledge.

MMS has a proven regulatory track record, providing global Regulatory Affairs Strategies and Services across a wide array of treatment areas and disciplines.

Regulatory Affairs Services

MMS Regulatory Affairs Services is focused on supporting companies as they advance their drug, biologic, device, and/or combination products through regulated pathways from development to commercialization. MMS Regulatory Affairs values and cultivates long-term client relationships and strives to function as an integrated and value-added extension of the Sponsor’s regulatory team framework. 

  • Regulatory Operations colleagues are industry-trained experts skilled at providing end-to-end regulatory operations support from managing, preparing, submitting, and archiving a diverse array of regulatory submissions to and from global health authorities.  
  • Regulatory Affairs Managers ensure compliance and provide the critical interface between the organization and global health authorities. 
  • Regulatory Strategists formulate, direct, and implement innovative and pressure-tested strategies and streamlined development plans that account for the minimum available data and acceptable levels of organizational risk.  

The path to success varies by Sponsor, product, and region. MMS provides bespoke solutions to fulfill organizational business goals for a wide range of pharma companies, from industry giants to biotech startups.  

Related Client Case Study

Regulatory Affairs Management Support

 Regulatory affairs management - case study A global regulatory affairs manager stepped in to manage a Sponsor team while their leader was on maternity leave. Under the MMS expert’s leadership the overall health of the established products programs were maintained, and all required submissions were made on time and met FDA standards for quality and content

Download the case study

Learn More About MMS Regulatory Affairs Services

Work with us to create an actionable regulatory strategy to support your optimal progress and development.

Explore how our Regulatory Affairs Managers can act as an extension of your regulatory affairs teams.

Learn more about our team’s expertise in submitting a diverse array of regulatory submissions to global health authorities.

Speak with a Regulatory expert

Data Management
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Data Management
& Biostatistics

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& Medical Writing

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Drug Safety
& Pharmacovigilance

Quality & Compliance 
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Quality & Compliance 



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