People · Technology · Automation

Senior regulatory expertise. Built to execute.

Regulatory leadership that stays through execution.

Arapta Life Sciences helps biotechnology and pharmaceutical companies navigate regulatory strategy, CMC, health authority interactions, and global submission execution with experienced people, modern technology, and practical automation.

From regulatory strategy and development planning through Regulatory CMC, eCTD publishing, quality control, lifecycle management, and regulatory intelligence, we help teams move critical programs forward with greater speed, visibility, and confidence. We support submissions to the U.S. FDA, EMA, Health Canada, and other global health authorities, and can coordinate with qualified in-country partners where local representation is required.

Accelerating Regulatory Affairs

Regulatory complexity should not slow scientific progress.

Arapta brings senior regulatory leadership and hands-on execution together with technology and automation, helping life sciences organizations move from strategy and CMC through submission and lifecycle management with greater speed, clarity, and confidence.

Our approach brings together three elements:

Strategy

Build the path forward.

Regulatory and operational planning aligned to development milestones, submission requirements, health authority interactions, and the target regulatory outcome.

CMC

Keep product and dossier aligned.

Regulatory CMC strategy across development and manufacturing: Module 3 and IMPD planning, process and site changes, comparability, and control strategy.

Operations

Execute with confidence.

Submission planning, eCTD publishing and validation, lifecycle and sequence management, agency correspondence, and filing execution.

Quality

Get it right before it goes out.

Independent document, sequence, and dossier-level quality control against defined acceptance criteria, with findings documented and traceable.

Insight

Turn information into regulatory advantage.

Regulatory intelligence, landscape analysis, pathway assessment, and operational visibility that help teams make better-informed decisions.

Enable

Apply technology where it pays.

Regulatory information management, workflow optimization, automation and AI-enabled processes, dashboards, and operating-model improvements.

A different model for regulatory support

Senior expertise. Integrated execution. Technology that serves the work.

Regulatory programs do not move in isolated functions. Strategy affects CMC. CMC decisions affect submissions. Health authority feedback changes development plans. Operational execution determines whether those decisions reach the agency accurately and on time.

Arapta brings these disciplines together. We provide senior Regulatory Affairs and Regulatory CMC leadership alongside the operational, submission, intelligence, and technology capabilities required to turn regulatory strategy into execution.

Arapta is built for life sciences companies that need senior regulatory expertise and the ability to execute it.

Method

Built for execution. Designed for inspection.

Every engagement begins with the regulatory program as it actually exists: current submissions, documents, timelines, systems, validation history, open commitments, and known risks.

From there, we establish the plan, define responsibilities and acceptance criteria, execute the work, and maintain a clear record of decisions and quality checks.

That means work moves faster without sacrificing the documentation, control, and traceability regulatory teams depend on.

Have a regulatory milestone ahead?

Tell us what you are planning, when you need to submit, and where the challenges are. We will help you define the work and determine the most effective path forward.

Capabilities

Seven connected capability areas, from regulatory strategy and CMC through operations, quality, intelligence, and technology — delivered as a defined scope, ongoing support, or embedded expertise inside your team.

01

Regulatory Strategy and RA Leadership

Global regulatory strategy, development planning, fractional and interim RA Lead support, health authority engagement, regulatory risk assessment, and submission strategy.

Areas of support

• —Fractional and interim RA Lead support
• —Global regulatory strategy and development planning
• —IND, CTA, NDA, BLA, and MAA planning
• —Regulatory pathway and risk assessment
• —Health authority meeting strategy and preparation
• —Cross-functional regulatory leadership and governance

Senior regulatory leadership when you need it, without waiting to build the full function.

02

Regulatory CMC Strategy and Support

RA CMC leadership, CMC development strategy, Module 3 and IMPD planning, manufacturing changes, comparability, health authority interactions, and lifecycle support.

Areas of support

• —RA CMC Lead support and CMC regulatory strategy
• —IND, CTA, IMPD, and Module 3 planning
• —Manufacturing process, site change, and comparability assessments
• —Control, specification, and stability strategy
• —CMC health authority preparation and information requests
• —Lifecycle and post-approval CMC strategy

Regulatory CMC strategy that keeps development, manufacturing, and submission plans aligned.

03

Regulatory Operations and Submission Management

Plan and execute regulatory submissions to the U.S. FDA, EMA, Health Canada, and other global health authorities with disciplined submission management, publishing, quality, and lifecycle support.

Areas of support

Submission execution from planning through lifecycle management. Arapta supports submissions to the U.S. FDA, EMA, Health Canada, and other global health authorities, helping life sciences organizations plan, prepare, publish, submit, track, and maintain complex regulatory dossiers. Where local representation is required, we can coordinate with qualified in-country partners.

Our support includes submission planning and management, eCTD publishing, document readiness, validation, agency gateway coordination, lifecycle management, health authority correspondence, and regulatory information management.

• —IND, NDA, BLA, CTA, and MAA submissions
• —U.S. FDA, EMA, Health Canada, and other health authority submissions
• —eCTD publishing, validation, and gateway coordination
• —Submission planning, tracking, and readiness
• —Health authority correspondence and responses
• —Lifecycle and post-approval submissions

04

Regulatory Writing and Content Readiness

Regulatory documents, submission content coordination, templates, formatting, document readiness, hyperlinks, bookmarks, and metadata.

Areas of support

• —Regulatory document preparation and coordination
• —Templates, formatting, and publishing standards
• —Hyperlinking, bookmarking, and cross-referencing
• —Document readiness criteria and metadata

05

Regulatory Quality and Compliance

Document and dossier quality control, submission validation, compliance checks, inspection-ready processes, and traceability.

Areas of support

• —Independent document, sequence, and dossier QC
• —Submission validation and compliance checks
• —Defined acceptance criteria and findings resolution
• —Inspection-ready processes and traceability

06

Regulatory Intelligence & Strategic Insights

Precedent research, regulatory landscape analysis, pathway assessment, strategic landscape intelligence, and decision support.

Areas of support

• —Regulatory precedent research
• —Health authority trends
• —Competitive development landscapes
• —Approval pathways
• —Agency decisions
• —Benchmarking
• —Regulatory risk signals
• —Emerging requirements

07

Technology, Automation and Process Transformation

Regulatory information management, workflow optimization, AI-enabled regulatory processes, automation, dashboards, and operating-model improvements.

Areas of support

• —RIM technology and system selection support
• —Process definition and workflow optimization
• —Practical automation and AI-enabled regulatory workflows
• —Tracking, reporting, and regulatory dashboards
• —Operating models for teams scaling submission volume

We apply technology where it improves regulatory execution, not where it adds another layer of complexity.

Define the right engagement

Engagements are structured around your regulatory objective, upcoming milestone, and the level of support needed, from a defined project to ongoing, fractional, or embedded expertise.

About Arapta

Regulatory leadership that stays through execution.

Arapta Life Sciences was founded to help life sciences companies move regulatory programs forward with greater clarity, speed, and confidence.

Our name reflects our mission: Accelerating Regulatory Affairs through People, Technology, and Automation.

Regulatory success depends on more than strategy, and more than execution. Development decisions affect CMC. CMC decisions affect submissions. Health authority feedback changes plans. And the quality of operational execution determines whether regulatory strategy reaches the agency accurately and on time.

Arapta brings these disciplines together.

We provide senior Regulatory Affairs leadership, Regulatory CMC support, Regulatory Operations, submission management, quality, regulatory intelligence, and technology-enabled process improvement as a connected regulatory model.

Our clients can engage Arapta for a defined project, fractional or interim leadership, embedded expertise, or ongoing regulatory support. The objective is the same: provide the right regulatory capability at the right point in development without requiring clients to build every function internally before they need it.

Technology and automation support that model rather than define it. We apply modern tools, data, and AI where they improve regulatory execution, reduce unnecessary manual work, strengthen quality, and provide greater visibility into critical activities.

Arapta supports submissions to the U.S. FDA, EMA, Health Canada, and other global health authorities. Where local representation or market-specific expertise is required, we can coordinate with qualified in-country partners while maintaining alignment across regulatory strategy, content, submission readiness, and quality.

Ultimately, our purpose is not simply to make regulatory work more efficient. It is to help organizations make better regulatory decisions, execute them effectively, and move important therapies toward patients.

Founder

Jason Lee

Founder & Managing Director

Jason Lee is a Regulatory Operations leader who has built and scaled global regulatory capabilities across biotechnology and pharmaceutical organizations.

Read full biography

Over the course of his career, Jason has led and supported regulatory submissions across development, registration, and post-approval programs, including INDs, NDAs, BLAs, CTAs, MAAs, and other global filings. His experience spans global submission strategy and execution, regulatory technology, RIM transformation, health authority interactions, regulatory intelligence, process optimization, and operational excellence.

Most recently, as Director and Head of Regulatory Operations at Eikon Therapeutics, Jason established the global Regulatory Operations strategy, team structure, and scalable operating model. During his time at Eikon, he delivered global submissions across multiple regions and led enterprise Veeva Vault RIM strategy, built in-house global publishing capabilities, expanded regulatory infrastructure across the United States, Europe, and Canada, and developed an enterprise roadmap for AI-enabled Regulatory Operations.

Earlier in his career, Jason held Regulatory Operations leadership positions across biotechnology and pharmaceutical organizations, where he built regulatory functions, submission capabilities, systems, processes, and operating models from the ground up. His experience includes global IND, CTA, NDA, BLA, MAA, and other filing programs, as well as submissions and health authority support across the FDA, EMA, Health Canada, and other global regulatory agencies.

At SK Life Science, Jason led Regulatory Operations activities supporting IND, NDA, and post-marketing programs and contributed to regulatory work associated with XCOPRI® (cenobamate), including support for the Korean market. His experience working across U.S., Korean, and global life sciences environments gives him a practical understanding of the regulatory and operational challenges organizations face when advancing programs across international markets.

Jason has also been an early advocate for applying emerging technology to Regulatory Affairs, with a focus on using AI and intelligent automation to strengthen regulatory intelligence, submission readiness, quality, visibility, and execution.

He founded Arapta Life Sciences around a simple principle: regulatory strategy should stay connected to execution. Arapta brings together senior regulatory expertise, technology, and practical automation to help life sciences organizations navigate complex development programs with greater clarity, speed, and confidence.

Complex regulatory programs require more than isolated specialists. Arapta’s model brings together senior regulatory leadership, CMC expertise, Regulatory Operations, quality, intelligence, and technology around the needs of each development program.

How we work

Start a conversation

South Korea & Asia

From Asia to the U.S. FDA.

Regulatory strategy, CMC, and submission support for South Korean and Asian life sciences companies pursuing U.S. development and market entry.

Arapta helps sponsors translate U.S. FDA expectations into actionable regulatory strategies, development plans, submission structures, operating processes, and execution-ready deliverables.

South Korea + Asia→U.S. FDAStrategy · CMC · Prepare · Submit · Engage

한국어로 보기

한국 및 아시아 바이오·제약 기업의 미국 진출을 지원합니다

Arapta Life Sciences는 한국 및 아시아의 바이오·제약 기업이 미국 시장에서 성공적으로 개발 및 규제 업무를 추진할 수 있도록 전문적인 Regulatory Affairs 지원을 제공합니다.

미국 FDA 규제 전략, IND 준비, Regulatory CMC, Regulatory Operations, eCTD 제출, Health Authority 대응 및 규제 기술·자동화까지 개발 단계와 목표에 맞춘 실질적인 지원을 제공합니다.

Arapta는 단순한 자문에 그치지 않습니다. 규제 전략을 실제 실행으로 연결하여 계획, 문서 준비, 제출 및 후속 규제 활동까지 고객과 함께합니다.

Senior regulatory expertise. Built to execute.

01

U.S. Regulatory Strategy

Regulatory pathway, development planning, risk assessment, and U.S. strategy aligned to FDA expectations and program milestones.

02

Regulatory CMC & IND Readiness

CMC regulatory strategy, IND content planning, submission readiness, and coordination across technical, quality, and regulatory teams.

03

FDA Meetings & Agency Engagement

Strategy and execution support for meeting requests, briefing packages, health authority questions, responses, and follow-through.

04

Global Submission Operations

Submission planning, eCTD publishing, validation, lifecycle management, metadata, and quality control, including eCTD 4.0.

05

RIM, Technology & Automation

Regulatory systems, data, workflows, and practical AI-enabled automation designed to improve visibility, quality, and execution.

06

Embedded Regulatory Expertise

Fractional, interim, or embedded RA, RA CMC, and Regulatory Operations support integrated with sponsor teams and development programs.

Discuss U.S. Regulatory Support

Join our network

Join the Arapta Network

We’re building a network of experienced life sciences professionals who can support client programs on a project, fractional, interim, or embedded basis.

We’re especially interested in experienced professionals across Regulatory Strategy, Regulatory CMC, Regulatory Operations, Regulatory Writing, Submission Management, Quality, Regulatory Intelligence, and Regulatory Technology & Automation.

Interested in working with Arapta?

Send a brief introduction and résumé/CV to careers@araptals.com. Please include your primary area of expertise, availability, and preferred engagement model.

We welcome experienced independent consultants as well as professionals interested in future opportunities with Arapta.

Contact

Tell us about your development program, upcoming regulatory milestone, timeline, and where you need support. Whether the need is regulatory strategy, CMC, submission execution, technology, or additional capacity, we’ll help determine the right way to engage.

What to include

• —Application type and region, and the sequence history if one exists.
• —Target submission date and any fixed authority milestones.
• —Current regulatory team, systems, external support, and operating environment.
• —Whether you need a defined project, ongoing support or embedded capacity.