RPI has 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 for investment in dedicated personnel and supplementing existing resources in times of high need. We have helped hundreds of clients reach their regulatory milestones with highly customized approaches.
Services
Product Development Strategy
RPI can help you design and implement a comprehensive plan to enable product development from early discovery through IND and post-approval lifecycle management. The RPI product development framework is built on the foundation of our strategic and tactical regulatory expertise. With access to a range of clinical research experts including therapeutic specialists, biostatisticians and clinical operations, RPI consulting can help design a product development plan that reduces risk and maximizes commercial success.
Regulatory Strategy
RPI’s regulatory consultants have extensive experience leading teams and providing strategic regulatory guidance in preparation for major submissions and global health authority meetings. Our services include preparing and reviewing documents to be submitted to regulatory agencies in support of clinical trials and marketing applications. We also help clients request expedited development designations, including orphan, breakthrough, PRIME, and advanced therapy medicinal products.
Electronic Publishing | eCTD Services
With the increasing demand for electronic filing and publishing, RPI distinguishes itself from other eCTD vendors with our customized approach to electronic common technical documents, 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 new drug applications, biologics license applications, drug master files, and marketing authorization applications, as well as submissions for the rest of the world. We guide clients through the eCTD submission process and provide customized expertise at every step of the approval process.
Medical Writing
RPI’s medical writers are seasoned professionals with advanced degrees. With expertise in subject-matter areas and the technical aspects of the regulatory environment, they have authored numerous 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.
Nonclinical Consulting
Optimizing nonclinical development can help maximize the likelihood of success in clinical development. RPI’s nonclinical safety experts have extensive experience working for the FDA and industry. We consult on pharmacology, drug metabolism and pharmacokinetics, and toxicology matters, including the strategic design and management of nonclinical studies related to investigational new drugs, new drug applications, and biologics license applications.
Chemistry, Manufacturing, and Controls (CMC)
RPI’s CMC Regulatory Affairs and Technical Services experts have managed numerous product development and manufacturing programs for small molecules and biologics, culminating in successful submission of CMC dossiers for investigational new drugs, clinical trial applications, biologics license applications, and new drug applications. Our extensive experience includes contract manufacturing organization selection and management for small molecules and biologics for drug substances and drug products, including aseptic fill and finish.
Quality Assurance
RPI has deep quality expertise in all types of good practices (GxPs). We assist clients with vendor qualification and selection and with auditing, review, and management of quality agreements, and we have firsthand experience with the design, construction, and validation of manufacturing facilities. Additionally, we have considerable experience leading sponsor inspections by health authorities in the United States and Europe, including mock inspection preparation. Our clinical quality expertise includes establishing and maintaining good clinical practice compliance programs for all phases of drug development. We also have extensive experience with GCP compliance audits of clinical sites, clinical laboratories, drug safety databases, data management centers, and contract research organizations.
Project Management
RPI offers strategic and tactical project management in all phases of drug development to organizations ranging from early-stage startups to some of the world’s largest life science companies. Our experts leverage their comprehensive project experience to strategically position and guide clients through a streamlined and customized approach that helps them achieve their drug development goals.
Electronic Trial Master Files (eTMFs)
RPI’s professionals have significant experience with both paper and electronic trial master files for clinical studies at all stages of development. RPI distinguishes itself from other eTMF vendors by leveraging next-generation regulatory content management solutions and facilitating clients’ management of data and documents for clinical trials, providing quality assurance, timely reports, and reconciliations throughout the lifecycle of a study.