Offerings

• Document Planning, Authoring, review and approval • Regulatory submission assembly and publishing • Regulatory submission delivery & tracking • Agency review and approval • Post approval follow-up • eCTD Submissions, eCTD 4.0 Consulting & Support • Nees Submissions • Paper Submissions • CSR- Report Level Publishing • Document Formatting Services • Archiving Submission Data • CDISC Legacy Data Conversions • Regulatory Data Migration • Publishing Consulting Services • Automation Services - Regulatory Submissions QC, Document Level Publishing

All activities that establish the submission plan, identify submission components, roles and responsibilities and promote an understanding of associated processes e.g.: Submission Planning and Management Team (SPMT) activities which promote emphasis on global participation to optimize harmonization of documents. • Submissions Management • Regulatory Operations • Content Planning

• Strategic Labeling Consulting / Go-to-Market Strategy • Labeling Translation • Labeling Compliance & Labeling Operations Tracking • HA Submissions • Label Comparisons • Submission Deferrals • Formatting & QC • Label Lifecycle Management • Structured Product Labeling (SPL) and Structured Product Monograph (SPM) • ePI • Clinical Labeling • Global Labeling Management (GLM)/ Core Labeling • Regional Labeling Management (RLM) • Content Deviation Management • Gap Analysis

• Artwork Process Consulting • Artwork Lifecycle Coordination • Artwork Studio Services (Creative Services, Product/Company Branding, Production Artwork, Artwork Adaptation) • Artwork Proofreading • Artwork Change Management • Artwork Management System • Global Artwork Translation • Artwork Illustrations • Technical Drawings (Cutterguides/Dielines) • Artwork Regulatory Compliance

Strategic consulting services that help customers define the optimal regulatory pathway for products and portfolios while transforming regulatory organizations for future readiness. The offering spans product-level regulatory strategy, portfolio planning, regulatory intelligence, and health authority engagement, alongside regulatory operating model and process consulting to optimize people, processes, governance, and technology across the regulatory function. Product & Portfolio Strategy – Regulatory pathway selection – Global development strategy – Market prioritization – Regulatory due diligence – Regulatory gap assessments – Health authority engagement strategy – Scientific advice planning and support – Portfolio optimization – Regulatory intelligence & policy monitoring Regulatory Transformation & Process Consulting – Process design and optimization – Governance framework design – Regulatory organization design – Digital transformation and technology enablement – Labeling operating model design – Due diligence process design – Change management and implementation support

End-to-end regulatory support for obtaining initial marketing authorizations and enabling successful product launches across global markets. The offering covers regulatory planning, dossier preparation, submission execution, health authority interactions, and local market entry support, ensuring efficient approvals and timely commercialization. Initial Registration & Submission Services – Regulatory submission strategy – Global submission planning and coordination – Marketing Authorization Applications (MAA/NDA/BLA/ANDA) – Initial registration submissions – Dossier authoring and compilation – eCTD publishing and validation – Submission management – Health authority submission support – Agency meeting coordination Market Entry & Affiliate Support – Local affiliate coordination – MAH and Local Legal Representative services – Country-specific application support – GMP certificate support – Market entry regulatory support

Comprehensive country- and region-specific regulatory services that ensure products remain compliant with local regulatory requirements throughout their commercial lifecycle. The offering provides dedicated affiliate support for regulatory execution, health authority engagement, license maintenance, and market-specific compliance activities. Services include: – Local regulatory submissions – Health authority interactions – Affiliate regulatory support – Regulatory correspondence management – Local dossier maintenance – Country-specific regulatory execution – Regulatory commitment tracking – License maintenance – MAH maintenance services – Local Labeling services – Artwork coordination – Translation and localization support – Legalization and notarization – Local regulatory intelligence

End-to-end lifecycle management services that support regulatory compliance following product approval. The offering enables efficient management of post-approval changes through strategic planning, submission execution, publishing, and coordination across global and local markets while ensuring continued regulatory compliance. Lifecycle Submission Management – Global lifecycle management – Variation management (IA/IB/II, CBE, PAS, etc.) – Renewals – Annual reports – Change management – CMC lifecycle management – Line extensions – Product transfers – Marketing authorization transfers – Withdrawal submissions Regulatory Operations & Compliance – Health authority query responses – Submission management – eCTD publishing – Regulatory publishing QC – Regulatory data management – RIMS support – Commitment tracking – Global coordination – Regulatory metrics and reporting

• Regulatory Intelligence Consulting • On-demand Regulatory Intelligence • Integrated Project Regulatory Intelligence Support • FTEs (Research Associates etc.) • Periodic RI updates (Newletters etc.)

• Regulatory Writing • Clinical Trial Consulting • Clinical Trial Audit & Monitoring • Quality Check & Medical Review of Regulatory Documents • Risk-Benefit Analysis • Clinical Data Transparency Initiative • Clinical Summaries & Overviews • Clinical Study Reports, IB, ICF, PLLR Support • Clinical Protocols, Design & Review • Scientific Advice & Briefing Packages • Clinical Investigation Plan (including PIP)

• Regulatory Toxicology (1. ADE/PDE/Determination/ Report Services 2. F-Value Reports for Child Resistant Packaging (CRP) 3. Toxicological Risk Assessment (TRA) of impurities, Extractables & Leachables 4. Environmental Risk Assessment (ERA) of medicinal products) • Scientific and Regulatory Review of Non-clinical Documents • Development and Review of Study Plans/Protocols for Non-clinical Studies • Non-clinical Development Strategy for Regulatory Submissions • Consultation on Non-clinical Issues in the Submissions • Consultation and Responses to Regulatory Queries • GLP Audits of Test Facilities • CRO Identification and Qualification for Non-clinical Regulatory Studies

• End-to-end Regulatory Compliance Services • SOP Authoring & Gap Analysis of process with alignment to regulatory requirements • GxP Audit Services • CSV & CSA Validation Service Offerings • Building QMS

• Medical Copywriting Services • Medical & Scientific Writing Services • Medical & Scientific Publication Services • Creative Scientific Design Studio • Promotional Regulatory Affairs (MLR Review etc.) • Ad Promo HA Submission & Consultation Services • Medical & Scientific Content Management

• RIMS Data Entry, Cleaning, Monitoring, Reports • RIMS Data QC • RIMS System Implementation & Upgrade Support • Data Migration Support (Data migration mapping, Data Verification) • Document Management (Uploads, Metadata review) • User Account Management (Admin activities, user account creation & management) • RIMS Training & Training Material Preparation • Data Visualization & Analytics • Europe - IDMP Consulting & Readiness Support, IDMP Data Management & Review,CTIS Data Management, XEVMPD Submissions