Preclinical, clinical data, and dossier expectations
Requirements we clarify up front
Approval pathways and lead-time ranges for planning
Pricing and reimbursement context that shapes launch timing
Regulatory Intelligence, Roadmap & Submission Strategy
01
Expert advice on regulatory strategy
02
Product lifecycle planning
03
Risk and gap analysis
04
GMP and GDP requirements
05
Product classification assessment
06
Regulations and compliance requirements
07
Quality Management Systems and Quality Assurance
Feasibility Assessment & Gap Analysis
Pre-submission assessment for feasibility and gap remediation
Preclinical, clinical data and dossier requirements
Approval pathways and lead time analysis
Registration fee guidance
Pricing and reimbursement policies
Pre-market Submissions, Marketing Authorization Applications
Project Management and engagement of subject matter experts
Module 1 Application preparation
eCTD / ACTD conversion, preparation and submission
Country specific dossier and labeling translation
Compliance review and assembly
Master files compliance evaluation
Product Registration and Health Authority Liaison
Submission filing to local regulatory agencies
Regulatory agency meetings and feedback management
Reimbursement application support
GMP and GDP audit inspections
Product Lifecycle Management & Pharmacovigilance & Compliance
Due Diligence on in-license and acquisition of marketing authorization
Key points
Post-market Surveillance and Pharmacovigilance
Periodic Safety Update Reports (PSUR)
Adverse event reporting
Gap analysis and remediation
Marketing Authorization Holder applications
Manufacturer site inspections
Import License applications
In and out licensing support
Transfer of license management
Product License holding and protection
Technology Transfer facilitation
Our Regulatory Consulting Roadmap Phase 1
Initial assessment of registration strategy in different countries
Our Regulatory Consulting Roadmap Phase 1
01
Pre-submission consultation with health authorities
02
Regulatory intelligence gathering
03
Market feasibility analysis
Preparation & Strategy
Communication with Client's RA team, gathering, reviewing and preparation of documents for submission
Key points
Dossier compilation and review
Multi-country submission strategy
Risk assessment and mitigation planning
PECAN.Solutions as your Virtual RA department
PECAN.Solutions Project Manager works with local consultants to obtain marketing approval
Ongoing regulatory support, pharmacovigilance, import & wholesale license applications, license holding
Key points
One central contact point with Client's RA, QA and Commercial teams
Coordination before documents are passed to local consultants for submission
Professional submission management
Health authority liaison and communication
Timeline management and progress reporting
Post-marketing follow up with health authorities
Ensuring regulatory compliance and maintaining product life cycle
Variation submissions and renewals
Ensuring registration strategy and documents required for submission to multiple countries are in order
Intelligence built for filing choices
We read guidelines the way submission teams do—looking for pathway risk, evidence gaps, and the moves that protect the critical path.
Intelligence deliverables
Expert advice on regulatory strategy by market and product class
Lifecycle planning across registration, variations, and renewals
Risk and gap analysis before you freeze the dossier plan
GMP and GDP requirements
Product classification assessment
Regulations and compliance requirements
Requirements we clarify up front
Preclinical, clinical data, and dossier expectations
Approval pathways and lead-time ranges for planning
Pricing and reimbursement context that shapes launch timing
We manage every aspect of your market entry
Engagement of subject matter experts
Module 1 Application
eCTD / ACTD conversion, preparation and submission
Country specific dossier and labeling translation, compliance review
Master files compliance evaluation
Submission filing to local regulatory agencies
Regulatory agency meetings and feedback
GMP and GDP audit inspections
Periodic Safety Update Reports (PSUR)
Adverse event reporting
Gap analysis and remediation
Import License Application
In and out licensing
Transfer of license
Product License holding and protection
Engagement styles that fit the work
On-site regulatory consulting and support when the room needs a local voice
Direct presence for authority meetings and inspections
Remote consulting for steady dossier and query cycles
Efficient virtual collaboration across time zones
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.
Do not 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.
Our team documents assumptions, authority expectations, and decision points so sponsors can approve the plan with clear risk ownership.
Local pharmacists and regulatory specialists stay accountable through query cycles, inspection readiness, and post-approval obligations.
We align labeling, Module 1 localization, and partner communications so commercial launch can follow approval without rework.
Where pathways differ by product class, we sequence filings to protect the critical path and avoid avoidable deficiency letters.
Engagements can scale from a single dossier workstream to a multi-country virtual regulatory function.
PECAN.Solutions scopes each workstream with milestones, document owners, and authority touchpoints so registration, license holding, and commercial access stay on one plan.
Engagement notes
- Our team documents assumptions, authority expectations, and decision points so sponsors can approve the plan with clear risk ownership
- Local pharmacists and regulatory specialists stay accountable through query cycles, inspection readiness, and post-approval obligations
- We align labeling, Module 1 localization, and partner communications so commercial launch can follow approval without rework
- Where pathways differ by product class, we sequence filings to protect the critical path and avoid avoidable deficiency letters
- Engagements can scale from a single dossier workstream to a multi-country virtual regulatory function
- PECAN.Solutions scopes each workstream with milestones, document owners, and authority touchpoints so registration, license holding, and commercial access stay on one plan
- Our team documents assumptions, authority expectations, and decision points so sponsors can approve the plan with clear risk ownership