AN ISO 9001:2015 CERTIFIED
Company Connect Consultancy
Drug Regulatory Affairs
Drug Regulatory Affairs Consulting Services
We provide end-to-end regulatory solutions that streamline every stage of your product’s journey — from early development to global market approval.
Our expert guidance ensures compliance with evolving international standards, minimizing delays and risks.
With strategic planning and efficient execution, we help you navigate complex regulatory landscapes.
Accelerate your product’s path to success with our comprehensive global regulatory expertise.
Strategic Regulatory Planning for Global Success
Navigate Complex Markets with Confidence
Our regulatory strategy development services provide a comprehensive roadmap for successful market entry across the US, EU, and Rest of World territories. We analyze regional requirements, identify potential challenges, and create tailored strategies that align with your business objectives.
From initial market assessment through commercialization, our experts ensure your regulatory pathway is optimized for efficiency, compliance, and speed to market. We leverage deep knowledge of global regulations to position your products for success.
Comprehensive Submission Expertise
IND Applications
Expert preparation of Investigational New Drug applications with thorough documentation and regulatory insight to support your clinical development program.
NDA & ANDA
MAA Submissions
Comprehensive New Drug Application and Abbreviated NDA services ensuring complete, compliant submissions that meet FDA requirements and expedite review.
Marketing Authorization Applications prepared to European standards, addressing EMA and national authority requirements for successful market authorization.
Lifecycle Management & Compliance Excellence
Proactive Regulatory Oversight
Our lifecycle management services ensure your products maintain compliance throughout their commercial life. We provide continuous monitoring of regulatory changes, assessment of impact on your portfolio, and strategic guidance for maintaining market authorization.
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•Real-time regulatory intelligence and change management
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•Post-approval commitments tracking and fulfillment
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•Periodic safety update reports (PSURs) and annual reporting
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•Compliance health checks and risk mitigation strategies
CTD/eCTD Dossier Preparation
Document Collection & Review
Comprehensive gathering and evaluation of all technical, clinical, and non-clinical data required for regulatory submission.
CTD Module Compilation
Expert structuring of modules 1-5 according to ICH guidelines, ensuring consistency, completeness, and regulatory alignment.
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eCTD Publishing
Professional electronic compilation with validation, quality control, and technical verification for seamless submission to health authorities.
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Regional Adaptation
​Tailored formatting and content adjustments to meet specific requirements of target markets including FDA, EMA, and ROW jurisdictions.
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Labeling & Registration Support Services
Labeling Compliance
​We provide comprehensive review and approval of product labeling, package inserts, and promotional materials to ensure full regulatory compliance and consistency across markets.
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•Label content review
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•Artwork verification
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​•Multi-market harmonization
Product Registration
We offer end-to-end support for initial product registrations, managing complex documentation requirements and authority interactions to secure timely approvals.
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​•Application preparation
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•Authority liaison
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•Query management
​Renewals & Variations
We manage license renewals and product variations strategically, ensuring continuous market presence and efficient implementation of product changes.
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•Renewal coordination
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•Variation submissions
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•Timeline management
Gap Analysis & Document Remediation
Assessment
Thorough evaluation of existing regulatory documentation identifying deficiencies, inconsistencies, and areas requiring enhancement for compliance.
Remediation Plan
Development of comprehensive action plans with prioritized recommendations, timelines, and resource allocation for addressing identified gaps.​​
Implementation
Expert execution of remediation activities, document updates, and quality assurance to bring materials into full regulatory compliance
Health Authority Liaison & Intelligence
Your Bridge to Regulatory Agencies
Our experienced team serves as your strategic liaison with global health authorities including FDA, EMA, and MHRA. We manage all aspects of authority communication, from pre-submission meetings to post-approval commitments, ensuring clear, professional interactions that advance your regulatory objectives.
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​Beyond liaison services, we provide ongoing regulatory intelligence monitoring changes in legislation, guidelines, and enforcement priorities. Our impact assessments help you anticipate regulatory shifts and adapt strategies proactively, minimizing risk and maximizing opportunity.
🇺🇸 FDA
Direct communication and meeting facilitation with US Food and Drug Administration.
🇪🇺 EMA
European Medicines Agency liaison and centralized procedure support.
🇬🇧 MHRA
UK regulatory authority engagement and post-Brexit compliance guidance.
Clinical Trial Application Support
Initial CTA Preparation
We meticulously prepare Clinical Trial Applications, including all necessary documentation and investigator brochures, ensuring efficient authority review and approval.
Protocol Amendments
Our team expertly manages protocol modifications and substantial amendments, ensuring timely submission and approval to maintain study timelines.​​
Safety Reporting
We provide comprehensive support for safety reporting obligations, including SUSARs, DSURs, and continuous safety monitoring throughout your program.
Partner with Regulatory Experts
Why Choose Our Services?
Deep Expertise
Decades of combined experience across all major regulatory jurisdictions and therapeutic areas.
Proven Track Record
Hundreds of successful submissions and approvals for pharmaceutical and biotech clients globally.
Strategic Partnership
Collaborative approach aligning regulatory strategy with business objectives for optimal outcomes.
