Strategic Drug Development
Navigating the Drug Approval Process
Engaging our services from the start of your program allows you the opportunity to proactively develop an optimal plan for successful drug approval (subject to drug efficiency and safety). Our team of industry experts can tailor our services to address your needs for all aspects of clinical trial and drug development, from pre-IND and regulatory health authority engagement to preclinical trials, all the way through to the pivotal phase III study.
RegDev’s team of consultants provide strategic advice and hands-on support with drafting, managing, reviewing, and editing documents -- including IND filings, meeting packages, and designation requests. We integrate and strategize with your cross-functional teams and subject-matter experts, take on responsibilities as regulatory lead for clinical studies, support clinical development programs, draft complex regulatory filings, and advise and help plan regulatory health authority engagements.
Strategic Drug Development — Service Details
CLIN-OPS SUPPORT
Ensures trials progress efficiently, ethically, and in compliance with regulatory requirements.
Learn MoreDOC CONTROL
An integral part of the QMS that establishes and maintains procedures to control documents.
Learn MoreeTMF SUPPORT
Demonstrates a clinical trial has been conducted following regulatory requirements.
Learn MoreGCP QA SUPPORT
Covers any activity that sustains a company's compliance with GCP guidances and regulations
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Covers all aspects of current Good Manufacturing Practices (cGMPs) and Quality Assurance.
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Verification process for all computerized systems, connected devices, and/or instruments used in a regulated environment.
Learn MorePROJECT MANAGEMENT
A structured approach to planning, organizing, and overseeing all aspects of a clinical trial to ensure its successful execution.
Learn MoreREGULATORY AFFAIRS
RA navigates the drug development regulatory environment and is the interface between industry and regulatory authorities.
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Provides guidance to interpret and implement Health Authority guidelines and to prepare and maintain Health Authority documentation.
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