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About PECAN.Solutions

Your Trusted Partner for Asian Pharmaceutical Market Entry Since 2007

Company Overview

Marketing Authorization Application Asia - Made Simple

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.

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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.

Marketing Authorisation Application Asia - oral solids
Marketing Authorisation Application Asia - liquids
Marketing Authorisation Application Asia - capsules

Our Network & Geographic Reach

Comprehensive Network Across Asia

PECAN.Solutions operates with a network of offices and licensed pharmacists strategically positioned throughout Asia's key pharmaceutical markets:

ASEAN Coverage:

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.

Our Expertise & Experience

Decades of Experience Supporting Global Companies

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

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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

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Lifecycle Management:

• Life-cycle product management and variations

• Distributor search, engagement and market penetration

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Our Regulatory Consulting Roadmap

Phase 1:

Pre-Market Assessment

Initial assessment of registration strategy in different countries

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• Pre-submission consultation with health authorities

• Regulatory intelligence gathering

• Market feasibility analysis

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

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• 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

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• 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

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• 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

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• Post-marketing follow up with health authorities

• Ensuring regulatory compliance and maintaining product life cycle

• Variation submissions and renewals

Our Comprehensive Service Framework

Strategic Regulatory Access to Markets Regulatory Strategy & Product Lifecycle Management

Product Classification

Product Classification Expertise

Regulatory Intelligence

Regulatory Intelligence Services

Pre-Market Submission

Pre-Market Submission Services

Post-Market Compliance

Post-Market Compliance Management

Market Access

Market Access 
Solutions

We provide expert guidance across all pharmaceutical categories:

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  • 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:

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  • 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:

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  • 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:

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  • 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:

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  • 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

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

Your Strategic Advantage in Asian Markets

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.

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Ready to Enter Asian Markets?

Let's Discuss Your Market Entry Strategy

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.

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