About PECAN.Solutions

Company Overview

Our Network & Geographic Reach

Our Expertise & Experience

Our Regulatory Consulting Roadmap

Our Comprehensive Service Framework

Strategic Regulatory Access to Markets Regulatory Strategy & Product Lifecycle Management

Product Classification Expertise

Regulatory Intelligence Services

Pre-Market Submission Services

Post-Market Compliance Management

Market Access Solutions

Our Service Delivery Model

Flexible Support Options

Why Choose PECAN.Solutions

Your Strategic Advantage in Asian Markets

Ready to Enter Asian Markets?

Let's Discuss Your Market Entry Strategy

Marketing Authorization Application Asia - Made Simple

Comprehensive Network Across Asia

Decades of Experience Supporting Global Companies

How We Guide You to Market Success

Singapore Malaysia Philippines Vietnam Thailand Hong Kong Taiwan Indonesia Services Commercial Access Regulatory Consultancy License Holding Quality Management System RLD and Bioequivalence Temperature Validation Contact Us Get In Touch About PECAN.Solutions Your Trusted Partner for Asian Pharmaceutical Market Entry Since 2007

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:

ASEAN Coverage:

Singapore

Malaysia

Indonesia

Philippines

Vietnam

Thailand

Macao

Cambodia

Extended Asia Coverage:

Hong Kong

Taiwan

China

Korea

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:

• Commercial market size and potential assessment

• 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

• Post-marketing pharmacovigilance

Lifecycle Management:

• Life-cycle product management and variations

• Distributor search, engagement and market penetration

Our Regulatory Consulting Roadmap Phase 1:

Pre-Market Assessment

Initial assessment of registration strategy in different countries

• Pre-submission consultation with health authorities

• Regulatory intelligence gathering

• Market feasibility analysis

Phase 2:

Preparation & Strategy

Communication with Client's RA team, gathering, reviewing and preparation of documents for submission

• Dossier compilation and review

• Multi-country submission strategy

• Risk assessment and mitigation planning

Phase 3:

Virtual RA Department

PECAN.Solutions as your Virtual RA department

• One central contact point with Client's RA, QA and Commercial teams

• Ensuring registration strategy and documents required for submission to multiple countries are in order

• Coordination before documents are passed to local consultants for submission

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

We provide expert guidance across all pharmaceutical categories:

NCE / NDA

Generics Biologics

Biosimilars

Orphan Drugs

Veterinary Medicines

Medical Devices

Advanced Drug-Device Combination Products

Cosmetics

Health Supplements

Food

TCM

Our comprehensive regulatory intelligence includes:

Expert advice on regulatory strategy

Product lifecycle planning

Risk and gap analysis

GMP and GDP requirements

Product classification assessment

Regulations and compliance requirements

Quality Management Systems

Quality Assurance

Preclinical, clinical data and dossier requirements

Approval pathways and lead time

Registration fee

Pricing and reimbursement policies

We manage every aspect of your market entry:

Project Management

Engagement of subject matter experts

Module 1 Application

eCTD / ACTD conversion, preparation and submission

Country specific dossier and labeling translation, compliance review and assembly

Master files compliance evaluation

CMC review

Submission filing to local regulatory agencies

Regulatory agency meetings and feedback

Reimbursement application

GMP and GDP audit inspections

Ongoing support includes:

Post-market Surveillance and Pharmacovigilance

Periodic Safety Update Reports (PSUR)

Adverse event reporting

Variation submission

Gap analysis and remediation

Renewal applications

We facilitate complete market access through:

Marketing Authorization Holder Application

Establishment Registration

Manufacturer Site Inspection

Import License Application

In and out licensing

Transfer of license

Product License holding and protection

Technology Transfer

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

Local Expertise, Global Standards

Our network of licensed pharmacists and regulatory specialists provides deep local knowledge while maintaining international quality standards.

Comprehensive Coverage

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.

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--> About Us | PECAN.Solutions - Asia Regulatory Affairs Experts Since 2007 top of page Home
Markets Singapore
Taiwan
Services Commercial Access
Regulatory Consultancy
License Holding
Quality Management System
RLD and Bioequivalence
Temperature Validation

Ready to Enter Asian Markets?

PECAN.Solutions is your trusted partner for navigating the complex regulatory landscape of Asian pharmaceutical markets. With our network of local experts and proven track record since 2007, we can help you bring your products to market efficiently and compliantly.