Regulatory Affairs Consulting
Uplift Your Regulatory Operations with our Regulatory Affairs Consulting Services
Increase the certainty of success by making the most of available data and cutting the time to regulatory approval
Regulatory Affairs consulting services available standalone or as part of a cross-functional product development project
Drug Discovery
- Product Development Plan
- Target Product Profile (TPP)
- SOPs (GLP, GMP, GCP)
Pre-clinical Development
- Regulatory and SME gap analysis
- Regulatory intelligence
- Global strategic product approval advice
- Product development strategies
- Regulatory project management
Initial Clinical Trial Application
- Trial design (drug and devices)
- Meetings and interactions with regulatory agencies
- IND/CTA/CTIS Applications
- Diversity Action Plan (DAP)
- Scientific advisory board support
Early Clinical Phase I-II
- Assessment of development feasibility and probability of success
- Assessment of market access requirements and feasibility
Late Clinical Phase III
- Health economics / outcomes support
- Define development / commercialization costs
- Due diligence
- Prepare Phase 3 investment proposals
Marketing Application
- Pre-submission support
- Regulatory agency interactions and responses
- Briefing packages
- Labeling
- NDA/MAA/BLA/ANDA/IDE Applications
- Risk management planning
- SME guidance for Advisory Committee meetings
Post-Marketing
- Respond to agency information requests
- Labeling/PIL updates
- Marketing Application maintenance
- Supplemental submissions/variations
- Line and patent extension
Special Programs
Orphan designation US/EU, Fast Track, Breakthrough, Accelerated Approval, PRIME, EUA. Strategy and submission support outside of USA and EU: UK, Australia (TGA), Canada (HC), Japan (PMDA), and China (CFDA) etc.
Strategic Regulatory Affairs Consulting for Integrated Product Development
Regulatory strategy is a pivotal part of a well-designed product development strategy and works in concert with key functional inputs such as:
- Preclinical development strategy– designing nonclinical studies to support safety and efficacy
- Clinical development strategy – strategizing on trial design, endpoints and data collection
- Clinical operations – ensuring that trials adhere to regulatory guidelines
- Biostatistics and data analysis – preparing compelling information for regulatory submissions and efficacy statements
- Manufacturing and quality assurance strategy– ensuring product quality and consistency throughout development
- Medical affairs – working together on communication strategies and presentation of clinical data to healthcare professionals and regulatory agencies
- Pharmacovigilance and safety – monitor and report adverse events to comply with post-market surveillance requirements
Push beyond regulatory compliance and improve your program’s outcome
Whether it’s pushing the boundaries of scientific research or technology, Certara’s Regulatory Affairs Strategy team thrives on innovation, leveraging deep expertise in concert with Certara’s functional aspects and a unique strategic approach to overcome anticipated and unanticipated challenges and expedite the global approval process.
Full Spectrum of Product Lifecycle Support
Integrated Scientific Expertise for Better Quality Outcomes
Global Footprint and Knowledge of Local Regulations
Technology-Enabled Regulatory Strategy
Apply Unmatched Scientific Acumen across the Full Product Development Lifecycle
A robust regulatory affairs strategy requires perspective and coordination across the drug development continuum as you scan not only the competitive landscape but the regulatory environment to build a plan that offers the highest probability of success.
Certara’s regulatory affairs consultants thrive on complexity. Our team is skilled at developing unique and novel solutions tailored to your needs in consultation with a broad range of Certara experts (CMC, Non-clinical safety and DMPK, clinical pharmacology, clinical science, biostatistics, commercial and market access) and leveraging key regulatory operations and medical writing support and available technologies.
Leverage Global Footprint to Cover All Major Health Authorities and Efficiently Navigate Local Requirements
Disseminating key strategic regulatory initiatives across functional areas and affiliates is imperative to successfully launch and maintain products and helps to foster a collaborative environment across any organization.
Certara’s regulatory strategy team spans the globe and is experienced in translating core strategies into local nuances that adhere to regional and national requirements. Our local presence and expertise include U.S. FDA, Health Canada, EMEA, the UK’s MHRA, China, Japan, South Korea and LATAM.
Make your Regulatory Affairs Strategy Actionable
Through collaboration with Certara regulatory strategy professionals, you can move the needle and make your health authority interactions more meaningful and valuable.
| Limited value Agency meeting question |
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Does the Agency agree that the Phase 2 study can be conducted in children and adult patients?
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Due to the unmet medical need for management of
Does the Agency agree that the Phase 1 SAD/MAD study design, particularly primary and exploratory objectives for evaluation of safety and tolerability, will enable collection of adequate data to support future study in patients? |
Prepare and Present Data to Receive a More Meaningful Response from Health AuthoritiesProgress Confidently to Next Milestone
Connect Regulatory Strategy and Operational Execution with Innovative Technology
Time is precious in drug development. As part of any regulatory affairs strategy engagement, an expert strategist will provide timelines for all submission-based activities from pre-agency discussions through product approval.
Working in concert with Certara’s medical writing team, we can draw a direct line from strategy to execution by facilitating document authoring and full-service global submission and publishing services. Medical Writers and Regulatory Operations teams utilize AI-enabled regulatory writing technology (CoAuthor) and trustworthy submission management software (GlobalSubmit) to generate significant efficiencies.
Support Acquisition Due Diligence and Regulatory Intelligence for More Confident Decisions
Careful examination of the regulatory landscape as well as a comparison of available drug development data enables more confident decision making. Certara’s Regulatory Strategy team in collaboration with Certara functional experts can consult on whether products in development are beneficial to patients compared to available treatments, and whether a product appears promising head-to-head against competing products from a potential investor standpoint. This approach balances shareholder value in the short term and patient value in the long term. By analyzing what’s missing from a product development plan and calling out red flags, Certara helps its customers ensure long-term regulatory and commercial viability.
Certara’s Regulatory Affairs Consultants
Geoff Fatzinger
Vice President, Regulatory Strategy
Geoff is the Vice President, Regulatory Strategy, Certara, responsible for providing strategic regulatory oversight to product development and commercialization. He is a highly experienced, results-oriented global regulatory professional, with very strong strategic capabilities and a very solid technical background that has allowed him to lead companies and projects to new levels of success in a variety of highly competitive industries, cutting-edge markets, and fast-paced environments. Geoff brings 20+ years of expertise and a demonstrated record of regulatory and business accomplishments covering the United States, Europe, Asia Pacific (with in depth experience in Japan, China, and Korea), and Middle East having lived and worked in many countries championing regulatory affairs.
Oxana Iliach, PhD
Senior Director, Regulatory Strategy and Policy
Oxana has more than 15 years of experience in the healthcare industry including the last 10+ years in regulatory affairs. She specializes in global regulatory strategy and drug development for rare diseases and small population with a focus on Chemistry, Manufacturing and Control (CMC). She has hands on experience with regulatory meetings and various types of submissions to EMA, FDA and Health Canada.
Daniel Smith
Director, Regulatory Strategy
Dan has 20+ years industry experience, ranging from lab-based non-clinical pathology to quality management to safety management and regulatory affairs. Dan has worked on a variety of projects that include ATMPs, consumer healthcare, emerging pharmaceuticals and top 10 pharmaceuticals, and has held several leadership and consulting positions. Prior to joining Certara, Dan was working at the forefront of microbiome science, exploring immuno-oncological, neurodegenerative CNS and gastrointestinal indications. Dan’s current focus is orphan drug development in the EU and US.
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