RPI has successfully helped companies achieve their drug and device development goals since 1995. Our proven track record and hands-on approach allow us to work with clients as part of their trusted team. RPI is uniquely positioned to provide the complete regulatory solution – providing the services of a fully-staffed regulatory department, from acting Head of Regulatory Affairs to specialized regulatory experts – reducing the need and investment for dedicated personnel, as well as supplementing existing resources in times of high need. We have helped hundreds of clients reach their regulatory milestones with highly customized approaches.
Services
Regulatory Affairs Strategy
RPI regulatory consultants have extensive experience leading teams and providing strategic regulatory guidance in preparation for major submissions and global health authority meetings. Services include preparation and review of documents submitted to regulatory agencies in support of clinical trials and marketing applications, including requesting expedited development designations (e.g. Orphan, Breakthrough, PRIME, ATMP).
Electronic Publishing | eCTD
With the increasing demand for electronic filing and publishing, RPI distinguishes itself from other eCTD Vendors with RPI’s customized approach, leveraging over 30 years of experience in regulatory affairs. RPI publishers have more than 15 years of publishing and document management experience, including significant experience preparing NDAs, BLAs, DMFs, MAAs, and rest of world submissions, and our goal is not only to guide clients through the eCTD submission process, but to provide customized expertise at every step of the approval process.
Medical Writing
RPI medical writers are technically versed as well as subject matter experts. Our medical writers are seasoned professionals with advanced degrees, who have authored multiple submission documents and co-authored scientific publications. Our writers focus on consistency of messaging and insightful interpretation of data to achieve high-quality documents that ensure positive outcomes.
Quality Assurance
RPI has deep Quality expertise in all areas of GxPs. We assist clients with vendor selection and audit, review and management of quality agreements and have first-hand experience with the design, construction and validation of manufacturing facilities. We have considerable experience leading sponsor inspections by health authorities in the US and Europe, including mock audit preparation. Clinical Quality expertise includes establishment and maintenance of GCP compliance programs for all phases of drug development and extensive experience with GCP compliance audits of clinical sites, clinical laboratories, drug safety databases, data management centers and CROs.
Project Management
RPI offers full-service strategic and tactical regulatory expertise in all phases of drug development to companies of all sizes ranging from early-stage startups to some of the world’s largest life science companies. RPI’s team of experts leverage our comprehensive submission experience to strategically position and guide clients through a streamlined and customized approach to achieve their drug development goals.
Electronic Trial Master File | eTMF
RPI professionals have significant experience with both paper and electronic Trial Master Files (eTMF) for clinical studies at all stages of development. RPI distinguishes itself from other eTMF vendors by leveraging next generation regulatory content management solutions and facilitates clients’ management of data and documents for clinical trials, providing quality assurance, timely reports, and reconciliations throughout the lifecycle of a study.