Expert pharmaceutical regulatory consulting and product registration services navigating FDA, EMA, MHRA, and 50+ regulatory authorities with proven success in CTD/ACTD dossier preparation and submission management
NAVIGATING REGULATORY PATHWAYS
Our regulatory affairs team provides comprehensive regulatory support from pre-submission strategy through post-approval lifecycle management. With expertise spanning US FDA, European Medicines Agency (EMA), UK MHRA, and emerging market authorities, we accelerate product approvals through strategic regulatory planning, expert dossier authoring in CTD and ACTD formats, and efficient submission management.
CTD/ACTD compliant regulatory dossier authoring
ICH-aligned Common Technical Document modules
Direct coordination with FDA, EMA, MHRA and 50+ authorities
OUR CAPABILITIES
End-to-end regulatory solutions from dossier preparation to post-approval support
Regulatory roadmap development, pathway selection (ANDA/NDA/MAA/505(b)(2)), submission timeline planning, regulatory gap analysis, competitive intelligence, risk assessment, and country prioritization for optimal market entry sequencing.
Expert authoring of Common Technical Document (CTD) Modules 1-5 and ASEAN Common Technical Dossier (ACTD) including Quality (Module 3), Nonclinical (Module 4), and Clinical (Module 5) sections meeting ICH guidelines and country-specific requirements.
Multi-country product registration including FDA ANDA/NDA/BLA submissions, EMA MAA (centralized/decentralized/mutual recognition procedures), MHRA applications, WHO prequalification, and emerging market registrations.
Chemistry, Manufacturing, and Controls (CMC) dossier preparation including pharmaceutical development reports (ICH Q8), analytical method validation, stability studies (ICH Q1), quality risk management (ICH Q9), and manufacturing process validation.
End-to-end submission coordination including eCTD (electronic Common Technical Document) compilation, regulatory authority portal uploads, deficiency response management, query handling, and approval tracking.
Lifecycle management including variation submissions (Type I/II), label updates, annual reports, renewal applications, regulatory change notifications, and post-marketing surveillance support.
GLOBAL PRESENCE
Regulatory expertise across FDA, EMA, MHRA, and 50+ global regulatory authorities
ANDA, NDA, BLA submissions | DMF preparation | 21 CFR compliance | FDA establishment registration | Post-approval supplements
MAA centralized procedure | Decentralized procedure | Mutual recognition | ASMF/CEP | EU GMP Annex compliance
Post-Brexit MAA(UK) | MHRA GMP inspections | UKCA marking | Parallel import licenses | WDA authorizations
China NMPA submissions | Japan PMDA | Australia TGA | Singapore HSA | ASEAN Common Technical Dossier (ACTD)
Brazil ANVISA | Mexico COFEPRIS | Colombia INVIMA | Argentina ANMAT | Peru DIGEMID
WHO Prequalification | Saudi SFDA | UAE MOH | Nigeria NAFDAC | South Africa MCC | Kenya PPB
HOW IT WORKS
Streamlined workflow ensuring efficient regulatory approvals
Product evaluation, target market analysis, regulatory pathway selection, gap analysis, documentation requirement compilation, and timeline estimation with regulatory strategy proposal.
CTD/ACTD dossier preparation: Module 1 (administrative), Module 2 (summaries), Module 3 (CMC quality), Module 4 (nonclinical), Module 5 (clinical). eCTD compilation per regulatory authority specifications.
Comprehensive dossier review for completeness, consistency, accuracy, and compliance with ICH guidelines. Gap identification and resolution before submission.
eCTD submission via regulatory authority portal (FDA ESG, EMA CESP, etc.), acknowledgment receipt confirmation, fee payment coordination, and application tracking number assignment.
Regulatory authority query/deficiency letter response preparation, additional data compilation, clarification provision, and amendment submission within specified timelines.
Marketing authorization receipt, labeling finalization, post-approval change management, annual reports, renewal submissions, and pharmacovigilance support.
PAPERWORK MADE EASY
Expert regulatory documentation for successful submissions
5-module ICH format dossier for FDA, EMA, MHRA, and ICH member countries
Type II DMF for API, Type III for packaging, Type IV for excipients
Abbreviated New Drug Application with bioequivalence studies for FDA
EMA submission via centralized, decentralized, or mutual recognition procedures
Clinical trial authorization application with nonclinical safety data
ASEAN Common Technical Dossier for Southeast Asian markets
ICH Q1A-F compliant stability data with shelf-life justification
Pharmacokinetic analysis demonstrating therapeutic equivalence to reference product
VISUAL OVERVIEW
Our regulatory affairs team, dossier preparation process, and compliance documentation operations
Let our regulatory experts accelerate your product approvals with strategic regulatory planning and expert dossier preparation. Contact us today to discuss your regulatory needs.
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