PECAN.Solutions

Pharmaceutical Expansion Commercial Access Network

Marketing Authorization Access Asia - Qualified and Made Easy for You

PECAN.Solutions has established a comprehensive pharmaceutical expansion and commercial access network to help foreign companies with little or no presence in Asia bring their products to market since 2007. We make marketing authorization access across Asia qualified and easy for you, with decades of experience in our team supporting small, medium-sized and multi-national biotech companies with end-to-end regulatory solutions and strategic market access.

Make the Right Choice -

Partner with Asia's most trusted regulatory affairs and commercial access network for simplified marketing authorization access.

Learn About Our Network

Network of offices and Pharmacists in ASEAN and Asia

How We Can Help You

With a network of offices and Pharmacists in ASEAN covering Singapore, Malaysia, Indonesia, Thailand, Vietnam, Philippines, Myanmar, Cambodia and Asia covering Hong Kong, Taiwan, China, Korea etc, we can represent you as your hub to Asia and beyond for your Pharmaceutical, Health & Beauty business.

Service Sectors

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

Strategize, Expand and Execute with Us

Overview of Our Consulting Roadmap

Business Need / Market Analyses

Advisory
Market survey
Competition Landscape
Feasibility
Local partner survey

Regulatory Analyses / Regulatory Strategy

Regulatory Intelligence
Regulatory analyses
Regulatory strategy
Multi-country strategy
Risk analyses and business advisory

Multi-country Regulatory Project Planning

Submission plan
Remediation plan
Post-market planning
Local partner planning

Regulatory Filing / Implementation

Execution of plan
Temporary marketing authorization holding
Local legal representative
Project management

Compliance / Business Maintenance

Post-market reporting
Compliance maintenance
Business maintenance
Variations
Local legal representative

Benefits

Valuable Outcomes

• Cost-effective virtual solutions and regulatory outsourcing

Access expert regulatory support without the overhead of in-house teams

• Single window project management backed by team of qualified consultants

One point of contact for all your Asian regulatory needs

• End-to-end Regulatory consultation, Marketing Authorization Application and License Holding

Complete solution from strategy to market maintenance

• Expert support for multi-country region-specific regulatory complexities

Navigate unique requirements across different Asian markets

• Local Responsible Persons or Pharmacists with Local language Interactions with Health Authorities (HAs)

Native speakers who understand cultural nuances

• Structured approach to ensure smooth and satisfactory project delivery

Proven processes that minimize delays and maximize success

Our Clients

We have extensive experience working with:

Pharmaceutical Companies:

• Pharmaceutical Manufacturers with own R&D molecules, Innovator or First to Market Generics

• Orphan Drug, right-to-license Pharma Product Owners

• Pharmaceutical Distributors with own or in-licensed products

Healthcare & Beauty Companies:

• Cosmetics, Medical Devices Brand Product Owners, Manufacturers, Distributors

Evidence of Success:

We have testimonials and case studies demonstrating our track record of successful market entries and regulatory approvals across Asia.

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.