Regulatory Affairs

Global Regulatory Affairs Services: Your Compass in the Complex World of Clinical Research

Bringing a life-changing therapy to market demands more than strong science—it requires navigating a complex, ever-evolving global legal and compliance landscape. Our specialized regulatory affairs services provide the strategic guidance, localized expertise, and end-to-end support necessary to secure timely approval for your clinical trials and, ultimately, your product.

We serve as your dedicated regulatory partner, translating complex regulatory requirements into a clear, executable roadmap. By integrating a regulatory strategy into your product development plan from day one, we help you reduce risk, accelerate timelines, and ensure total compliance with global health authority
standards.

Strategic Regulatory Guidance: From Concept to Commercialization

Success in regulatory affairs starts long before a submission is filed. It begins with a robust, forward-looking strategy that anticipates challenges and optimizes your pathway to market.

1. Regulatory Strategy and Planning

We collaborate with you to develop a tailored regulatory strategy that aligns with your product’s profile, therapeutic area, and target markets.

Global Development Plans: Creating a synchronized plan for multi-regional
development, identifying the most efficient sequence for trials and submissions
across different geographies.
Gap Analysis and Risk Mitigation: Proactively identifying potential compliance
gaps or scientific deficiencies in your current data package and developing
mitigation strategies to prevent costly delays or refusals.
Expedited Pathways Support: Leveraging our expertise to secure accelerated
designations from health authority interactions, such as FDA Fast Track,
Breakthrough Therapy, and EMA PRIME, to significantly shorten time-to-market
for qualifying therapies.

2. Clinical Trial Regulatory Submission Management

The initiation of a clinical trial hinges on successful applications to regulatory bodies. Our global team is expert in compiling, formatting, and submitting all necessary dossiers, managing their entire lifecycle.

Investigational New Drug (IND) Applications: Comprehensive preparation and
submission of FDA submissions for the U.S. market, providing the necessary
documentation to allow shipment of the investigational product and initiation of
clinical trials.
Clinical Trial Applications (CTAs) / Investigational Medicinal ProductDossiers (IMPDs): Managing clinical trial regulatory submission for theEuropean Union, including the evolving requirements of the Clinical TrialsRegulation (CTR) and applications to national Competent Authorities. The IMPD(a detailed document about the drug being tested and its manufacturing) is acritical component we handle with meticulous detail.
Global Submissions: Beyond the major regions, our local regulatory specialists manage applications for all major and emerging markets, ensuring local language and format requirements are met to accelerate site activation worldwide.

3. Health Authority Interactions & Communication

Effective dialogue with regulatory agencies is key to managing expectations and resolving issues quickly.
Scientific Advice and Pre-Submission Meetings: Organizing and leading strategic meetings with FDA submissions and EMA submissions contacts to gain
clarity and agreement on pivotal trial designs, preclinical data, and overall
development plans.

Response to Queries: Rapidly compiling and submitting comprehensive, high-
quality responses to all questions and requests from regulatory bodies during the
review process, ensuring submission clocks are restarted quickly.

Global Expertise, Local Compliance Consulting

The fragmented nature of global regulations requires a team with on-the-ground knowledge. Our regulatory team is strategically dispersed across the globe, providing unparalleled regional expertise.

Deep Regional Regulatory Expertise

Our regulatory affairs services encompass all major jurisdictions, allowing for
synchronized global development:

United States (FDA)

Key Submissions Managed
IND, BLA (Biologics License Application), NDA (New Drug Application), Orphan Drug Designation.

Compliance Consulting Focus
21 CFR, cGMP (current Good Manufacturing Practice) adherence, and eCTD (Electronic Common Technical Document) publishing.

European Union (EMA)

Key Submissions Managed
CTA, MAA (Marketing Authorisation Application), Paediatric Investigation Plan (PIP).

Compliance Consulting Focus
EU Clinical Trials Regulation (CTR), EMA centralized procedure requirements, and EU data protection standards.

Asia-Pacific (APAC)

Key Submissions Managed
Submissions to PMDA (Japan), NMPA (China),
MFDS (South Korea).

Compliance Consulting Focus
Local clinical trial registry requirements and specific in-country testing/manufacturing rules.

Comprehensive Post-Approval and Lifecycle Maintenance

Our commitment doesn’t end with marketing approval. We provide full lifecycle
management to maintain your product’s regulatory standing.

Marketing Application Development: Preparation and publishing of the final
Marketing Authorisation Application (MAA) for Europe and the New
Drug/Biologics License Application (NDA/BLA) for the U.S.
Labeling and Advertising Review: Ensuring all proposed product labeling,
promotional materials, and patient information conform to approved regulatory
standards.
Life Cycle Management: Handling variations, renewals, change of ownership,
and other post-market submissions to ensure continuous adherence to all
clinical trial regulatory submission requirements.

Partner with our global team to transform regulatory hurdles into a competitive advantage, accelerating your path to delivering new therapies to patients worldwide.