Marketing Authorisation Transfers (MAT)
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:
Medical Devices & Consumer Health
Product Registration Holding (PRH)
Local Authorisation Representative (LAR)
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:
Key points
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:
Key points
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:
Key points
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:
Key points
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
Key points: 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
Expert guidance through the entire transfer process
License holding for existing registered products that are divested or in-licensed from another company
Risk Mitigation & Protection
Negate distributor risks for issues that may arise with distributors
Independent license holding protects your license's commercial value
Maintain control over your valuable market authorizations
Avoid future complications when taking back licenses from distributors for divestment or distributor changes
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
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
Avoid money lost due to preventable issues, as seen in many industry examples
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.
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.
Audit-qualified QMS in place since 2013 with local pharmacists, QA persons, and GDP-compliant facilities ready to support your products immediately.
Negate distributor risks and maintain control over your licenses while authorized distributors handle commercial activities under our regulatory oversight.
Our team documents assumptions, authority expectations, and decision points so sponsors can approve the plan with clear risk ownership.
Local pharmacists and regulatory specialists stay accountable through query cycles, inspection readiness, and post-approval obligations.
We align labeling, Module 1 localization, and partner communications so commercial launch can follow approval without rework.
Where pathways differ by product class, we sequence filings to protect the critical path and avoid avoidable deficiency letters.
Due Diligence Expertise
Ensure in-licensing and acquisition due diligence are conducted
Ensure in-licensing and acquisition due diligence are conducted properly to avoid red-flags and costly issues that could derail major business endeavors.
Independent license holding enables efficient multi-country market access
Independent license holding enables efficient multi-country market access with centralized regulatory management across Asian markets.
Do not let regulatory complexity or distributor dependencies
Do not 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
Contact us today to discuss how our license holding expertise can secure and optimize your Asian market presence.