Your Independent Regulatory Partner

Product Categories We Support

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 and In-vitro Diagnostics

Cosmetics

Health Food & Supplements

License Holding Services

Our Experience

How We Can Help

Complete License Holding Solutions for Your Business

Our Case Studies

Why Choose PECAN.Solutions for License Holding

Ready to Secure Your Asian Market Presence?

License Holding Asia

Marketing Authorisation Holding (MAH) License Representation

Complete Commercial Access Solutions Across All Healthcare Categories

Proven Infrastructure Since 2013

Proven License Holding Success

Your Competitive Advantage in Asian Markets

Let's Protect Your License Holdings

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 License Holding Asia Your Independent Regulatory Partner Marketing Authorisation Holding (MAH) License Representation Secure your market presence across Asia without the overhead of establishing local entities. Our independent license holding services provide complete regulatory representation through Marketing Authorization Holders (MAH), Product Registration Holders (PRH), and Local Authorized Representatives (LAR).

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:

Medical Devices & Consumer Health:

• Marketing Authorisation Transfers (MAT)

• Product Registration Holding (PRH)

• Local Authorisation Representative (LAR)

• Manufacturer Representation

Regulatory Requirements Across Asia

Local country regulations mandate local business or pharmaceutical entities for product registration submissions and post-approval Pharmacovigilance. Depending on countries, local pharmaceutical entities may require:

• Presence of licensed Pharmacists

• Local Responsible Person for Pharmacovigilance (LPV or LPPV)

• Local Quality Assurance (QA) personnel

• Store or warehouse address with Good Distribution Practice (GDP) compliance

• Necessary Quality Management System (QMS) in place and audit-readiness

Local Communication Requirements

Local Health Authorities (HA) usually prefer to communicate in native languages, necessitating the presence of:

• Local Marketing Authorisation Holder (MAH)

• Product Registration Holder (PRH)

• Local Authorised Representative (LAR)

• Local responsible persons for Health Authority communications

The Cost of Building Your Own Infrastructure

Such an infrastructure setup is not only costly to maintain, but also requires:

• Setup and maintenance of comprehensive QMS

• Trained regulatory professionals and pharmacists

• Compliant storage facilities and distribution systems

• Ongoing operational overhead and management

Our Ready Infrastructure

We have established local pharmaceutical entities with local qualified persons and Pharmacists to support clients with:

• Product registrations and license holding

• Post-approval Pharmacovigilance and lifecycle management

• License registration and holding for drugs, biologics, medical devices, cosmetics

• Audit-qualified QMS for Good Distribution Practice (GDP) and Pharmacovigilance since 2013

Time & Cost Savings

• Save significant time and expense as we represent you as MAH/PRH/LAR for product registration and follow up to approval

• Eliminate the need for establishing your own local presence in each country

Import License & Distribution Management

• Obtain import licenses on your behalf when needed

• Work with your appointed distributor as independent license holder and authorized representative

• Authorize third-party distributors to import and distribute your registered product (where allowed)

• Provide ongoing post-approval regulatory and pharmacovigilance activities

Marketing Authorization Transfer Support

• Marketing Authorization Transfer consultation for complex transactions

• License holding for existing registered products that are divested or in-licensed from another company

• Expert guidance through the entire transfer process

Risk Mitigation & Protection

• Negate distributor risks for issues that may arise with distributors

• Independent license holding protects your license's commercial value

• Avoid future complications when taking back licenses from distributors for divestment or distributor changes

• Maintain control over your valuable market authorizations

Due Diligence Excellence

• Comprehensive due diligence for in-licensing and acquisition projects

• Thorough review of necessary documents, processes and infrastructure

• Prevent red-flags and costly issues that could derail major business endeavors

• Avoid money lost due to preventable issues, as seen in many industry examples

• Due Diligence for in-licensing, acquisition of Pharmaceutical product or manufacturing site

• Advantage of Independent License Holding and multi-country market access

• In-license of divested innovative biologic product

• Distributor Breach of Contract

Cost & Time Savings

Save significant time and expense as we represent you as MAH/PRH/LAR for product registration and follow-up to approval, eliminating the need for your own local presence.

Risk Mitigation

Independent license holding relieves impact on your license's commercial value, avoiding future issues when taking back licenses from distributors for divestment or distributor changes.

Established Infrastructure

Audit-qualified QMS in place since 2013 with local pharmacists, QA persons, and GDP-compliant facilities ready to support your products immediately.

Distributor Independence

Negate distributor risks and maintain control over your licenses while authorized distributors handle commercial activities under our regulatory oversight.

Due Diligence Expertise

Ensure in-licensing and acquisition due diligence are conducted properly to avoid red-flags and costly issues that could derail major business endeavors.

Multi-Country Coverage

Independent license holding enables efficient multi-country market access with centralized regulatory management across Asian markets.

Don't let regulatory complexity or distributor dependencies jeopardize your Asian market access. Our independent license holding services, backed by audit-qualified infrastructure since 2013, provide the security and flexibility you need to maintain control over your valuable market authorizations.

Singapore

Malaysia

Indonesia

Philippines

Vietnam

Thailand

Macao

Cambodia

Laos

Hong Kong

Taiwan

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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.