GHRE
Global Hub for Regulatory Excellence
Now Serving 50+ Countries Worldwide
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🌐 Global Regulatory Excellence — One Platform
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EXCELLENCE
One Platform · Global Regulatory Excellence
Global Hub for
Regulatory Excellence
Empowering global healthcare innovation through strategic regulatory, compliance, and market access solutions — built on scientific rigor, regulatory intelligence, and global compliance standards.
50+
Countries Served
100+
Regulatory Experts
200+
Successful Projects
100%
Excellence Commitment
Trusted Industry Partners
Supporting Our Growth
Delivering Regulatory Excellence Across
50+
Countries & Regions
Multi-Jurisdiction
Regulatory Submissions
Full Lifecycle
Compliance Support
14 Service Lines
Across Healthcare Sectors
100%
Commitment to Excellence
Who We Are
A Globally Connected Regulatory Platform
GHRE is a globally connected regulatory consulting platform delivering strategic compliance, regulatory affairs, and international market access solutions for the healthcare industry worldwide — grounded in scientific rigor, regulatory intelligence, and global compliance standards.
Trusted by healthcare innovators, manufacturers, and regulatory professionals worldwide for strategic compliance, regulatory, and market access solutions across 50+ countries.
Scientific Rigor
Every strategy is grounded in current science, evidence-based dossier preparation, and deep knowledge of ICH guidelines and regional technical requirements.
Regulatory Intelligence
Continuous monitoring of global regulatory developments, translated into clear and actionable compliance strategies for your business.
Global Compliance Standards
Operating at the intersection of local requirements and international best practices, ensuring your products meet the standards of every target market.
End-to-End Partnership
From first-in-human studies to post-approval lifecycle management, GHRE remains your regulatory partner at every stage of the product journey.
Regulatory Frameworks We Cover
FDAEMAWHO
MHRADRAPTGA
Health CanadaPMDA
SFDA
ICH GuidelinesEU MDR/IVDR
ISOGMP/GCP/GLP
+ Many More
"Where deep knowledge meets global regulatory precision — connecting the world's healthcare innovators to the compliance expertise they need."
GHRE — Core Mission
100+
Regulatory Experts
50+
Countries Active
200+
Projects Delivered
100%
Excellence Commitment
10+
Global Frameworks
Who We Are
Built on Four Founding Principles
Every engagement at GHRE is guided by a clear set of values that define how we think, collaborate, and deliver for our clients worldwide.
🌐 Bridging Borders. Elevating Standards.
🤝 People First. Partnership Always.
🛡️ Compliant Today. Confident Tomorrow.
💡 Knowledge Drives Clarity. Integrity Builds Trust.
What We Do
End-to-End Regulatory Solutions
Comprehensive regulatory services across the product lifecycle — helping you achieve compliance, accelerate market access, and drive global success.
01
Regulatory Strategy & Lifecycle Management
Full-cycle regulatory planning from early development to post-approval lifecycle maintenance, ensuring compliance at every stage.
- Pre-submission regulatory pathway analysis
- Target market submission strategy development
- Post-approval variation and renewal planning
- Regulatory risk identification and mitigation
- Global lifecycle maintenance support
02
Regulatory Affairs Consulting
Expert regulatory planning, dossier submissions, and lifecycle support for global markets — tailored to your therapeutic area and target jurisdictions.
- Regulatory intelligence and gap analysis
- Authority interaction strategy and management
- Labeling and artwork compliance review
- Regulatory due diligence for M&A activities
- Scientific advice meeting preparation
03
Quality & Compliance Management
QMS implementation, GMP compliance, audit support, and inspection readiness programs aligned with global quality standards.
- Quality Management System (QMS) design
- GMP gap analysis and remediation planning
- Mock inspection preparation and conduct
- CAPA development and effectiveness monitoring
- Supplier qualification and audit support
04
Clinical Trial Regulatory Support
Regulatory guidance for clinical trials including approvals, ethics submissions, IND/CTA support, and trial lifecycle compliance.
- IND and CTA preparation and submission
- Ethics committee submission support
- Clinical trial protocol regulatory review
- Investigator site regulatory compliance
- Trial lifecycle and amendment management
05
Pharmaceutical Compliance
Global pharmaceutical compliance support aligned with FDA, EMA, WHO, and regional international regulatory standards.
- Pharmaceutical compliance gap assessments
- ICH guideline implementation support
- Regulatory compliance training programs
- Deviation and OOS investigation support
- Product recall and withdrawal management
06
QbD & Pharmaceutical Development
Integration of Quality by Design principles into product and process development, including risk management and design space development.
- Quality Target Product Profile (QTPP) development
- Critical Quality Attribute (CQA) identification
- Design of Experiments (DoE) planning
- Control strategy development and validation
- Process Analytical Technology (PAT) integration
07
Medical Device Solutions
Full-cycle support for medical device registration, classification, technical file preparation, and regulatory compliance.
- Device classification and pathway determination
- Technical file and Design Dossier preparation
- EU MDR/IVDR compliance and transition support
- FDA 510(k) and PMA submission support
- Post-market surveillance system design
08
Biosimilars Regulatory Solutions
Comprehensive regulatory support for biosimilars including development strategy, dossier preparation, and global submissions.
- Biosimilar development regulatory strategy
- Analytical similarity and comparability planning
- Clinical pharmacology and PK/PD study design
- Immunogenicity assessment strategy
- Biosimilar labeling and interchangeability guidance
09
Nutraceuticals Regulatory Support
Specialized regulatory services for nutraceutical products including classification, compliance strategy, and market authorization.
- Product classification and regulatory status assessment
- Claims substantiation and labeling compliance
- Novel food and health claim applications
- Market authorization dossier preparation
- Country-specific nutraceutical compliance
10
International Market Access
Strategic guidance to navigate regulatory pathways and accelerate product access across international markets.
- Global regulatory landscape mapping
- Market entry regulatory pathway analysis
- Parallel submission strategy and coordination
- Named patient and compassionate use programs
- HTA regulatory alignment and strategy
11
Pharmacovigilance & Drug Safety
Adverse event reporting, risk management systems, safety monitoring, and post-market regulatory compliance.
- Adverse event and ICSR case processing
- PSUR/PBRER aggregate report preparation
- Risk Management Plan (RMP) development
- Signal detection and safety surveillance
- PV system audit and compliance assessment
12
Documentation & CTD/eCTD & ACTD/eACTD & NeeS Support
High-quality regulatory dossiers, CTD/eCTD preparation, technical writing, and publishing support.
- CTD Module 1–5 compilation and review
- eCTD sequence preparation and publishing
- Regulatory technical writing and editing
- Dossier gap analysis and remediation
- Submission-ready document quality review
13
Regulatory Intelligence & Market Monitoring
Continuous tracking of global regulatory updates, guidelines, and market-specific compliance insights.
- Real-time regulatory update monitoring
- Guideline impact assessment and briefings
- Competitive regulatory intelligence reports
- Regulatory horizon scanning services
- Custom regulatory alert subscription service
14
Trade Mark & Legal Consultancy
Comprehensive trademark registration and legal advisory services to protect your brand and ensure compliance with applicable laws and intellectual property frameworks.
- Trademark search, filing & registration with IPO Pakistan
- Legal consultancy for intellectual property and brand protection
- Documentation support, renewals & enforcement guidance
- Brand compliance strategy across international markets
- IP due diligence for mergers and acquisitions
Our Engagement Approach
A Structured Path to Regulatory Success
Five disciplined phases — from discovery to lifecycle stewardship — ensuring precision and compliance at every step.
Phase 01
Strategic Discovery & Assessment
We engage with your team to develop a deep understanding of your product profile, regulatory landscape, target markets, and commercial objectives to define a clear engagement foundation.
1
2
Phase 02
Regulatory Strategy & Pathway Design
We build a tailored, risk-informed regulatory strategy that aligns with global requirements, market access priorities, and your long-term business goals.
Phase 03
Compliance Enablement & Documentation Support
We support the structured development and review of regulatory documentation, ensuring alignment with applicable standards, scientific expectations, and submission readiness.
3
4
Phase 04
Submission Management & Authority Engagement
We manage end-to-end submission processes and act as your regulatory liaison, facilitating efficient communication with health authorities and timely resolution of queries.
Phase 05
Lifecycle & Post-Approval Stewardship
We provide continuous regulatory support beyond approval, including variations, renewals, safety compliance, pharmacovigilance, and lifecycle optimization to sustain market presence.
5
Our Expertise
Where Deep Knowledge Meets Global Precision
Our certified regulatory professionals bring scientific depth, strategic insight, and jurisdiction-specific knowledge to every engagement — across diverse therapeutic areas, product categories, and international markets.
🌐
Global Regulatory Strategy
Tailored regulatory roadmaps aligned with your product profile and target markets — from early development to post-approval lifecycle management.
- Multi-market regulatory pathway analysis
- Regulatory risk assessment and mitigation planning
- Pre-submission meetings and agency interaction strategy
- Lifecycle management and variation planning
📋
Dossier Preparation & CTD/eCTD Publishing
Submission-ready dossiers built to the highest global standards — from Module 1 to Module 5 with full compliance across regional formatting requirements.
- CTD and eCTD compilation and publishing
- Module 1–5 technical writing and review
- Regional document adaptation (FDA, EMA, ICH markets)
- Gap analysis and dossier remediation
🔬
GMP, Quality Systems & Inspection Readiness
Deep expertise in QMS design, GMP compliance, and regulatory inspection preparation — helping organizations build robust quality frameworks.
- QMS design, implementation, and gap analysis
- GMP audit preparation and mock inspections
- CAPA development and effectiveness monitoring
- FDA, EMA, and WHO inspection readiness support
🧬
Clinical & Nonclinical Regulatory Science
Supporting the full spectrum of clinical development — from first-in-human studies to pivotal trials — ensuring regulatory alignment at every phase.
- IND, CTA, and ethics submission preparation
- Clinical study protocol regulatory review
- Nonclinical data package assessment
- Pediatric investigation plan (PIP) and study waiver support
🛡️
Pharmacovigilance & Risk Management
End-to-end drug safety systems that protect patients and ensure continuous post-market compliance across global regulatory frameworks.
- ICSR reporting and PSUR/PBRER preparation
- Risk Management Plan (RMP) and REMS development
- Signal detection, evaluation, and escalation
- PV system audits and compliance gap assessments
⚕️
Medical Device Regulatory Expertise
From classification to post-market surveillance — comprehensive expertise across EU MDR/IVDR, FDA 510(k), PMA, and international device frameworks.
- Device classification and regulatory pathway determination
- Technical file and Design Dossier preparation
- EU MDR/IVDR conformity assessment support
- Post-market surveillance and vigilance reporting
💉
Biosimilars & Biologics Regulatory Science
Scientific expertise combined with regulatory strategy to navigate the complex and evolving global biosimilar and biologics landscape.
- Biosimilar development strategy and comparability planning
- Immunogenicity assessment and clinical bridging
- FDA and EMA biosimilar pathway guidance
- Biological dossier preparation and submission support
🏷️
Labeling, Artwork & Packaging Compliance
Full compliance with jurisdiction-specific labeling requirements from day one — preventing submission delays and market withdrawals.
- Global labeling strategy and gap analysis
- PIL, SmPC, IFU, and package insert development
- Artwork review and compliance verification
- Labeling change management across markets
📡
Regulatory Intelligence & Horizon Scanning
Continuous monitoring of global regulatory developments — translated into actionable intelligence so your business is always one step ahead.
- Real-time tracking of FDA, EMA, WHO, and regional updates
- Competitive regulatory landscape analysis
- New guideline impact assessments
- Tailored regulatory intelligence reports and briefings
🎓
Regulatory Training & Capacity Building
Structured training programs, workshops, and mentorship that build internal regulatory capability — driving long-term compliance and efficiency.
- Customized regulatory affairs training programs
- GMP, pharmacovigilance, and clinical compliance workshops
- Regulatory writing and dossier preparation training
- Ongoing regulatory mentorship and advisory support