NPG's regulatory experts empower Life Science companies with strategic regulatory leadership and unmatched compliance expertise.
NPG’s unique blend of consulting and staffing regulatory solutions enables pharmaceutical and medical device companies to navigate complex regulatory landscapes with ease, and supports projects from strategy to execution, adapting seamlessly to challenges at every stage.
We offer a full spectrum of flagship regulatory affairs services designed to meet the evolving needs of our clients. These services ensure compliance, reduce time-to-market, and support your strategic goals in the pharma and medical device industries.
» Regulatory Submissions
» New Product Development Services
» RA Subscription Service
» Regulatory Change Management
» Regulatory Remediation Services
» Regulatory Sustaining Services
» Acquisitions Due Diligence and Integration
» Regulatory CMC Services
» Pharmaceutical Regulatory Labeling Services
Navigating the complex landscape of medical device and pharmaceutical submissions can be daunting. NPG guides you through every step, whether preparing 510(k), PMA, CE Marking documentation, INDs, NDAs, ANDAs, or BLAs. Our team specializes in authoring, managing, and optimizing submissions to ensure compliance, align with your approval objectives, and support efficient regulatory success.
Bringing new medical device and pharmaceutical products to market involves navigating complex regulatory landscapes and executing precise planning. NPG offers comprehensive regulatory support from early development through launch, providing strategic guidance for classification, risk assessments, regulatory pathway determination, and essential documentation. Our expertise spans medical devices, pharmaceuticals, digital health solutions, and personalized medicines. We prioritize efficient compliance at every stage to accelerate your path to market success and support sustainable product innovation.
Need ongoing regulatory expertise? NPG's RA Subscription Service offers a flexible model, providing access to seasoned professionals for routine tasks, updates, and strategic guidance. This ensures your team remains agile and well-supported without needing full-time internal resources.
Medical device regulations are constantly evolving. NPG provides the support you need to adapt, conducting impact assessments and developing regulatory strategies to ensure your devices remain compliant throughout their lifecycle. Our experts manage necessary submissions and help you stay ahead of the curve.
Facing a compliance gap? NPG's remediation experts swiftly assess your documentation and processes to identify areas of non-compliance. Our team develops a tailored remediation plan, updating strategies and correcting deficiencies to ensure your devices meet standards and maintain market access.
Compliance doesn't end with product launch. NPG provides comprehensive post-market support, managing surveillance, reporting, and labeling updates. Proactively monitoring regulatory changes, NPG ensures your devices remain compliant throughout their lifecycle, allowing you to focus on innovation.
Acquiring a new company with medical devices? NPG facilitates smooth transitions by managing due diligence, document remediation, and regulatory submissions. Our experts handle compliance and integration steps, ensuring acquired products meet standards without disrupting your resources.
Meeting regulatory standards for Chemistry, Manufacturing, and Controls is crucial. NPG provides comprehensive CMC services, guiding you through requirements and developing robust strategies. Our CMC experts author detailed documents and manage responses to health authority queries, facilitating smoother approvals.
Maintaining compliance throughout your product lifecycle is essential. NPG provides ongoing support, managing post-market surveillance, labeling updates, and change management. Our experts proactively monitor changes and provide guidance to help you sustain market access and fulfill post-approval commitments.
Accurate labeling is crucial. NPG ensures your product labels meet all requirements and reflect current safety and efficacy information. Our team manages the creation, review, and updates of labeling documents, including prescribing information and patient leaflets, in compliance with global standards.
NPG’s Regulatory Center of Excellence was instrumental in leading us through our complex submission process. Their deep knowledge of FDA and EU MDR requirements, combined with proactive guidance, ensured our compliance and helped us launch on time, without any costly delays.
— Mid-Size Pharmaceutical Client
VP Regulatory Affairs
Explore our regulatory whitepapers in our resources to learn how we’ve guided clients through complex compliance challenges with precision, insight, and strategic expertise to deliver robust compliance, minimize delays, and achieve regulatory excellence across global markets.
Ritu is an accomplished regulatory affairs professional with over 18 years of experience in the life sciences industry, including medical devices, pharmaceuticals, and biotech. As the President of Regulatory Affairs at Network Partners Group, Ritu has led the company through critical projects and business growth. With a Master’s degree in Regulatory Affairs from Northeastern University and a Bachelor’s degree in Honour Microbiology from the University of Guelph, Ritu has a proven track record in regulatory strategy, submissions, and agency interactions across the US, EU, and Canada.
"*" indicates required fields
