8 Regulatory Affairs Providers for Clinical Trials in 2026

A regulatory affairs provider helps a sponsor navigate the strategy, documentation, and formal submissions required to move a product from clinical trial application through marketing authorization, work that spans everything from IND/CTA preparation to responses to health authority questions. This kind of regulatory affairs provider ranges from strategic consultancies staffed by former agency reviewers, to specialized regulatory writing firms, to the software platforms that manage the electronic submission process itself.

The regulatory affairs providers below are listed in no particular order. Between them, these companies and providers cover strategic regulatory consulting, electronic submission and eCTD publishing software, medical device and IVD-specific regulatory expertise, and regulatory writing and dossier preparation services.

Donawa Lifescience Consulting

Donawa Lifescience Consulting was founded by Dr. Maria E. Donawa, who began the company in Rome shortly after spending six years at the US FDA's Center for Devices and Radiological Health (CDRH), and has specialized in medical device, in vitro diagnostic, and combination product regulatory affairs for more than 25 years. The company operates as a full-service CRO from headquarters in Rome and a US subsidiary in Cambridge, Massachusetts, giving device manufacturers a single source spanning feasibility studies through commercialization for both US FDA and EU CE marking pathways. Donawa's expertise includes IVD performance studies across technologies such as DNA-based diagnostics, and clinical evaluation reports and equivalence determinations required under the EU's Medical Device and In Vitro Diagnostic Regulations. The company also provides European Authorized Representative and UK Responsible Person services for non-European device manufacturers navigating post-market regulatory requirements.

Eliquent

Eliquent Life Sciences was formed through the strategic merger of six regulatory consultancies, including Validant, Greenleaf Health, DataRevive, Oriel STAT A MATRIX, and IDEC, a Japan-focused regulatory specialist, unifying decades of separate expertise under a single global brand. Headquartered in Washington, D.C. and backed by European healthcare investor GHO Capital, the firm draws heavily on former senior FDA and EMA officials, and reports having supported more than 160 IND submissions with a 98 percent success rate, along with more than 50 breakthrough therapy applications. Eliquent's practice spans regulatory affairs, quality and compliance, pharmacovigilance, and CMC (Chemistry, Manufacturing and Controls) strategy across pharmaceuticals, biologics, medical devices, and combination products. The firm operates across the US, Europe, and the Asia-Pacific region, supporting clients from early IND/CTA preparation through marketing authorization submissions and post-approval lifecycle management.

Ennov

Ennov was founded in 1999 by CEO Olivier Pâris and has built a Unified Compliance Platform spanning Regulatory, Quality, Clinical, Pharmacovigilance, and Commercial applications, allowing life sciences companies to manage regulated content and processes within a single connected system rather than a patchwork of disconnected tools. The Paris-based company reports serving more than 450 life sciences customers and roughly 500,000 total platform users, with named clients including Boehringer Ingelheim, Kenvue, and Viatris. In May 2026, Ennov announced a strategic growth investment led by private equity firm Bregal Sagemount, with participation from Ardian, aimed at accelerating the company's push into AI-powered regulatory and compliance tools. Ennov 11.0, released in late 2025, added built-in AI features including automatic eCTD document classification and an in-platform AI chatbot that answers questions about a company's own regulatory documents and records.

Five Office

Five Office has operated as a Swiss service provider to the pharmaceutical industry since 1978, offering clinical research, regulatory affairs, quality, and pharmacovigilance services alongside health marketing and medical and scientific translation, drawing on a network of more than 800 external collaborators. The company belongs to the Swiss Engel Group, which also includes a pharmaceutical company and entities spanning material sciences, nutrition, and finance, giving Five Office access to broader corporate resources beyond a typical independent consultancy. Five Office's regulatory affairs practice covers marketing authorization applications, Qualified Person services, submissions to Swissmedic, and legal representation for companies without a Swiss presence. The company also reviews pharmaceutical promotional materials for compliance with Switzerland's strict advertising regulations, a specialized service area distinct from most general regulatory consultancies.

IDEA Regulatory

IDEA Regulatory is a science-led regulatory consultancy that helps pharmaceutical, biotech, and medtech developers navigate clinical trial and product development pathways across multiple jurisdictions, with particular depth in orphan and rare disease drug development. The company's services include joint FDA-EMA Orphan Drug Designation applications, EU representation for non-EU sponsors handling clinical trial applications and CE marking, and regulatory submissions management, positioning the firm as a preferred vendor that larger CROs use for outsourced legal representation and independent regulatory advice. IDEA's team draws on senior figures with more than 40 years of combined experience in regulated medical sector R&D, including a former chief investigator and CRO CEO whose company was later acquired by Syneos. The company serves emerging biotech and global pharma clients across North America, Europe, and Asia-Pacific.

KLIFO

KLIFO was founded in Denmark as a contract research organization in 1994, and CEO Alejandra Mørk acquired the company in 2008, developing it over the following decade into an integrated drug development consultancy spanning regulatory affairs, clinical development, clinical trial supply, quality assurance, and CMC development. Headquartered in Copenhagen with additional offices in Sweden, Germany, and the Netherlands, the company employs more than 150 people and took a strategic majority investment from healthcare-focused private equity firm Gilde Healthcare to support its international growth. In October 2025, KLIFO received Danish Medicines Agency approval for a new 6,500-square-meter clinical trial supply facility in Copenhagen, expanding its packaging and distribution capacity for Nordic and international clients. The company has more recently focused on scaling its higher-value Advisory business across Drug Development Consulting, Regulatory Affairs, CMC, and Quality Assurance, while reducing its exposure to full-service CRO work, particularly in the Nordics.

LORENZ Life Sciences

LORENZ has been at the center of the regulatory submission software industry since 1989, when the company pioneered DAMOS, one of the first official standards for electronically submitting documents from industry to regulatory authorities, later playing a central role in defining the eCTD format itself. The company's flagship docuBridge platform added its first eCTD publishing module in 2000, and LORENZ submitted the first eCTD compliant with draft ICH specifications in 2003, well ahead of the format's eventual global adoption. LORENZ won the FDA's first tender for a submission review solution in 2016, and again in a follow-up tender in 2017, a process that ultimately migrated 1.2 million existing submissions onto the LORENZ platform for the agency's internal review use. The company reports more than 1,300 paid installations across 38 countries, and its product family has expanded to include LORENZ eValidator for submission validation and LORENZ verifAI, an AI-powered productivity tool for regulatory teams.

Whitsell Innovations

Whitsell Innovations was founded in 2006 by Robin Whitsell and has grown into a WBENC-certified, woman-owned medical and scientific writing company specializing in regulatory writing across preclinical, clinical, and CMC documentation for pharmaceutical, biotech, and medical device clients. The company, based in Chapel Hill, North Carolina, expanded into electronic regulatory submissions in 2019 through its acquisition of Pharmakey, a Durham-based firm that had provided strategic publishing and regulatory consulting services using LORENZ docuBridge software since 2009. Whitsell Innovations operates as a fully remote company with staff across 27 US states, and in 2022 was named runner-up for the DIA's “8 That Innovate” recognition for custom-programmed tools the company built in-house to support its writing and quality control teams. The company specializes in ICH E3-format clinical study reports and offers what it calls rescue medical writing, taking over projects that another vendor has already started but not completed to the client's satisfaction.

Explore the full Regulatory Affairs landscape

The companies above represent a portion of a much larger field.

Diligent's platform includes over 500 Regulatory Affairs Vendors, with Vendor qualification data available on demand. Talk to our team about accessing qualification data for this category.

This article is intended as an informational overview of vendors operating in this space. Inclusion on this list does not constitute an endorsement, recommendation, or qualification by Diligent.