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:
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 & Consumer Health:
Medical Devices and In-vitro Diagnostics
Cosmetics
Health Food & Supplements
License Holding Services
Marketing Authorisation Holding (MAH) License Representation
• Marketing Authorisation Transfers (MAT)
• Product Registration Holding (PRH)
• Local Authorisation Representative (LAR)
• Manufacturer Representation
Our Experience
Proven Infrastructure Since 2013
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
How We Can Help
Complete License Holding Solutions for Your Business
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
Our Case Studies
Proven License Holding Success
• 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
Why Choose PECAN.Solutions for License Holding
Your Competitive Advantage in Asian Markets
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.
Ready to Secure Your Asian Market Presence?
Let's Protect Your License Holdings
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.
Contact us today to discuss how our license holding expertise can secure and optimize your Asian market presence.