Commercial market size and potential assessment
Our Network & Geographic Reach
Entering the ASEAN and Pan-Asia pharmaceutical market involves navigating diverse regulations, cultural nuances, and unique healthcare infrastructures. Regulatory challenges necessitate the involvement of local entities and regulatory expertise to ensure adherence to local regulations and streamline market entry.
PECAN.Solutions has established a network of local entities to help foreign companies with little or no presence in Asia bring their products to market since 2007.
PECAN.Solutions operates with a network of offices and licensed pharmacists strategically positioned throughout Asia's key pharmaceutical markets:
Extended Asia Coverage
We can represent you as your comprehensive hub to Asia and beyond for your pharmaceutical, health & beauty business, providing local expertise and regulatory knowledge in each market.
With decades of combined experience in our expert team, we support small, medium-sized and multi-national biotech companies with comprehensive regulatory solutions including:
Commercial & Strategic Services
Regulatory intelligence, feasibility assessment, and dossier gap analysis
Market entry strategy development
Regulatory Affairs Services
Pharmaceutical product and drug master file dossier review, preparation and product registrations
Representation as independent Product Registration Holders (PRH) or Marketing Authorization Holders (MAH)
Local Authorized Representatives (LAR) services
Quality & Compliance Services
Compliance and quality management systems
Handling audits and qualifications
Life-cycle product management and variations
Distributor search, engagement and market penetration
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
Regulatory intelligence that changes decisions
Intelligence only matters if it alters filing order, budget, or partner choice. We turn agency reading into actions your RA and commercial teams can own together.
What you get from our intelligence desk
Clear advice on regulatory strategy for each target market
Product lifecycle planning from first filing through renewals
Risk and gap analysis before dossier spend locks in
GMP and GDP requirements
Product classification assessment
Regulations and compliance requirements
Quality and access signals we map early
Preclinical, clinical, and dossier requirements by product class
Approval pathways and realistic lead times for planning
Pricing and reimbursement policies that affect launch economics
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
How we show up for your team
On-site regulatory consulting when presence accelerates decisions
Direct local representation with health authorities when required
Remote regulatory consulting for efficient week-to-week progress
Virtual collaboration that keeps global and Asian teams aligned
Local Expertise, Global Standards
Our network of licensed pharmacists and regulatory specialists
Our network of licensed pharmacists and regulatory specialists provides deep local knowledge while maintaining international quality standards.
From initial market assessment to post-marketing compliance, we
From initial market assessment to post-marketing compliance, we provide end-to-end regulatory solutions across multiple Asian markets.
Proven Track Record
Since 2007, we have successfully guided numerous pharmaceutical companies through complex Asian regulatory landscapes.
Cost-Effective Virtual Solutions
Access expert regulatory capabilities without the overhead of establishing in-house teams in each market.
PECAN.Solutions stands ready to be your trusted partner for navigating Asia's complex pharmaceutical regulatory environment. Our experienced team and extensive local network can accelerate your market entry while ensuring full regulatory compliance.
Contact us today to learn how we can support your Asian expansion goals.
Our team documents assumptions, authority expectations, and decision points so sponsors can approve the plan with clear risk ownership.