Regulatory Consultancy Asia
Health Economics & Outcomes Research (HEOR)
Regulatory Affairs End-to-End Support
Navigate Asia's complex regulatory landscape with confidence. Our regulatory consultancy provides comprehensive end-to-end support from pre-market strategy to post-market compliance, backed by local entities with audited Quality Management Systems across ASEAN markets.
Evidence-Based Market Access Solutions
Proven Local Regulatory Infrastructure
Audited Quality Management Systems & Local Entities
We have our own local entities and network of entities, under our qualified and audited Quality Management Systems by local authorities as well as by European clients, ensuring compliance with local Good Distribution Practices as well EU Pharmacovigilance to support as local marketing authorization holders.
Our team of consultants are locally hired with native language capabilities, backed up by Project Managers, ensuring project reliability, assured delivery and business continuity without disruption in case of absenteeism due to sickness or resignation.
We have combined decades of experience dealing with all the different product categories and are effective communicators with the local health authorities to support product registration and life cycle management as well as post-marketing Pharmacovigilance.
Product Categories We Support
Complete Commercial Access Solutions Across All Healthcare Categories
PECAN.Solutions supports companies seeking geographic expansion for their healthcare products across the full spectrum of pharmaceutical and healthcare categories:
Pharmaceuticals & Advanced Therapies:
Pharmaceuticals, Therapeutic Products, Orphan Drugs
New Chemical Entities, New Drugs, Generic Drugs, Drug Master File
Biologics, Biosimilars, Vaccines, Advanced Drug Therapy, Cell Gene Therapy
Medical Devices & Consumer Health:
Medical Devices and In-vitro Diagnostics
Cosmetics
Health Food & Supplements
Regulatory Consultancy Services
End-to-End Regulatory Affairs Support
01
Evidence Synthesis & Reviews
Regulatory Intelligence, Roadmap & Submission Strategy
• Systematic literature reviews and feasibility assessments
• Advanced meta-analyses and evidence synthesis
• Efficacy and safety data analysis
• Burden of illness and quality of life studies
• Treatment pattern analysis and real-world evidence
• HTA-compliant evidence generation
• Systematic literature reviews and feasibility assessments
• Advanced meta-analyses and evidence synthesis
• Efficacy and safety data analysis
• Burden of illness and quality of life studies
• Treatment pattern analysis and real-world evidence
• HTA-compliant evidence generation
• Systematic literature reviews and feasibility assessments
• Advanced meta-analyses and evidence synthesis
• Efficacy and safety data analysis
• Burden of illness and quality of life studies
• Treatment pattern analysis and real-world evidence
• HTA-compliant evidence generation
02
Economic Evaluation & Modeling
Feasibility Assessment & Gap Analysis
• Cost-effectiveness and cost-utility analyses
• Budget impact modeling and forecasting
• Markov modeling and decision tree analysis
• Quality-adjusted life years (QALY) calculations
• Economic burden of disease studies
• Sensitivity analysis and scenario modeling
• Cost-effectiveness and cost-utility analyses
• Budget impact modeling and forecasting
• Markov modeling and decision tree analysis
• Quality-adjusted life years (QALY) calculations
• Economic burden of disease studies
• Sensitivity analysis and scenario modeling
• Cost-effectiveness and cost-utility analyses
• Budget impact modeling and forecasting
• Markov modeling and decision tree analysis
• Quality-adjusted life years (QALY) calculations
• Economic burden of disease studies
• Sensitivity analysis and scenario modeling
03
Health Technology Assessment
Pre-market Submissions, Marketing Authorization Applications
• HTA dossier preparation and submission
• NICE, CADTH, PBAC, and other HTA body submissions
• Reimbursement strategy and negotiation support
• Health authority engagement and communication
• Value demonstration and evidence synthesis
• Post-HTA support and appeals management
• HTA dossier preparation and submission
• NICE, CADTH, PBAC, and other HTA body submissions
• Reimbursement strategy and negotiation support
• Health authority engagement and communication
• Value demonstration and evidence synthesis
• Post-HTA support and appeals management
• HTA dossier preparation and submission
• NICE, CADTH, PBAC, and other HTA body submissions
• Reimbursement strategy and negotiation support
• Health authority engagement and communication
• Value demonstration and evidence synthesis
• Post-HTA support and appeals management
04
Real-World Evidence & Outcomes
Product Registration and Health Authority Liaison
• Real-world data collection and analysis
• Patient-reported outcomes (PRO) studies
• Comparative effectiveness research (CER)
• Post-marketing surveillance and safety studies
• Health-related quality of life assessments
• Long-term outcomes and durability studies
• Real-world data collection and analysis
• Patient-reported outcomes (PRO) studies
• Comparative effectiveness research (CER)
• Post-marketing surveillance and safety studies
• Health-related quality of life assessments
• Long-term outcomes and durability studies
• Real-world data collection and analysis
• Patient-reported outcomes (PRO) studies
• Comparative effectiveness research (CER)
• Post-marketing surveillance and safety studies
• Health-related quality of life assessments
• Long-term outcomes and durability studies
05
Market Access Strategy
Product Lifecycle Management & Pharmacovigilance & Compliance
• Global market access strategy development
• Pricing and reimbursement optimization
• Value-based pricing and contracting
• Market segmentation and targeting
• Competitive intelligence and benchmarking
• Launch strategy and market penetration
• Global market access strategy development
• Pricing and reimbursement optimization
• Value-based pricing and contracting
• Market segmentation and targeting
• Competitive intelligence and benchmarking
• Launch strategy and market penetration
• Global market access strategy development
• Pricing and reimbursement optimization
• Value-based pricing and contracting
• Market segmentation and targeting
• Competitive intelligence and benchmarking
• Launch strategy and market penetration
06
Evidence Communication
Due Diligence on in-license and acquisition of marketing authorization
• Scientific publication strategy and support
• Conference presentations and abstracts
• Evidence communication and stakeholder education
• Health economics training and capacity building
• Value communication and advocacy
• Digital health and technology assessment
• Scientific publication strategy and support
• Conference presentations and abstracts
• Evidence communication and stakeholder education
• Health economics training and capacity building
• Value communication and advocacy
• Digital health and technology assessment
• Scientific publication strategy and support
• Conference presentations and abstracts
• Evidence communication and stakeholder education
• Health economics training and capacity building
• Value communication and advocacy
• Digital health and technology assessment
Our HEOR Services Roadmap
Phase 1:
Pre-Market Assessment
Initial assessment of registration strategy in different countries
• Health technology assessment strategy
• Economic evaluation planning
• Real-world evidence study design
How We Guide You to Market Success
Phase 2:
Preparation & Strategy
Communication with Client's RA team, gathering, reviewing and preparation of documents for submission
• HTA dossier development
• Regulatory submission support
• Health authority engagement
Phase 3:
Virtual RA Department
PECAN.Solutions as your Virtual RA department
• Post-launch evidence generation
• Market access optimization
• Stakeholder engagement
Phase 4:
Product Registration
PECAN.Solutions Project Manager works with local consultants to obtain marketing approval
• Professional submission management
• Health authority liaison and communication
• Timeline management and progress reporting
Phase 5:
Post-Marketing Support
Ongoing regulatory support, pharmacovigilance, import & wholesale license applications, license holding
• Post-marketing follow up with health authorities
• Ensuring regulatory compliance and maintaining product life cycle
• Variation submissions and renewals
Our HEOR Service Framework
Strategic Regulatory Access to Markets Regulatory Strategy & Product Lifecycle Management
Economic Evaluation
Real-World Evidence
HTA Support
Market Access
Value Communication
We provide expert guidance across all pharmaceutical categories:
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Oncology & Rare Diseases
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Cardiovascular & Metabolic
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Neurology & Psychiatry
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Infectious Diseases
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Autoimmune & Inflammatory
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Pediatric & Women's Health
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Geriatric & Long-term Care
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Digital Health & Technology
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Precision Medicine
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Cell & Gene Therapy
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Medical Devices & Diagnostics
Our comprehensive regulatory intelligence includes:
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Expert advice on regulatory strategy
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Product lifecycle planning
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Risk and gap analysis
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GMP and GDP requirements
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Product classification assessment
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Regulations and
compliance requirements -
Quality Management
Systems -
Quality Assurance
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Preclinical, clinical data and dossier requirements
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Approval pathways and lead time
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Registration fee
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Pricing and
reimbursement policies
We manage every aspect of your market entry:
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Project Management
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Engagement of subject matter experts
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Module 1 Application
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eCTD / ACTD conversion, preparation and submission
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Country specific dossier and labeling translation, compliance review and assembly
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Master files compliance evaluation
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CMC review
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Submission filing to local regulatory agencies
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Regulatory agency meetings and feedback
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Reimbursement application
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GMP and GDP audit inspections
Ongoing support includes:
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Post-market Surveillance and Pharmacovigilance
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Periodic Safety Update
Reports (PSUR) -
Adverse event reporting
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Variation submission
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Gap analysis and remediation
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Renewal applications
We facilitate complete market access through:
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Marketing Authorization
Holder Application -
Establishment
Registration -
Manufacturer Site
Inspection -
Import License
Application -
In and out licensing
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Transfer of license
-
Product License holding and protection
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Technology Transfer
Our Service Delivery Model
Flexible Support Options
We provide comprehensive support through:
On-site regulatory consulting & support
Direct presence when needed
Remote regulatory consulting & support
Efficient virtual collaboration
Dedicated technical staff
Specialized expertise for your projects
Why Choose PECAN.Solutions for Regulatory Consultancy
Your Competitive Advantage in Asian Regulatory Markets
Audited Local Infrastructure
Local entities with Quality Management Systems audited by local authorities and European clients, ensuring full compliance with local GDP and EU Pharmacovigilance requirements.
Native Language Capabilities
Locally hired consultants with native language capabilities, backed by experienced Project Managers for reliable delivery and business continuity.
End-to-End Regulatory Solutions
From initial market assessment to post-marketing compliance, we provide complete regulatory consultancy services under one roof.
Cost-Effective Virtual Solutions
Single window project management backed by qualified local consultants, providing expert regulatory support without in-house overhead.
Health Authority Relationships
Effective communicators with local health authorities across Asia, ensuring smooth product registration and lifecycle management.
Structured Project Delivery
Proven approach ensuring smooth and satisfactory project delivery with business continuity safeguards.
Ready to Navigate Asian Regulatory Markets?
Let's Build Your Regulatory Strategy
Don't let regulatory complexity delay your Asian market entry. Our regulatory consultancy team, backed by audited local entities and decades of experience, is ready to guide you through every step of the regulatory process across Asia's diverse healthcare markets.
Contact us today to discuss how our regulatory consultancy expertise can accelerate your Asian market approvals.