PECAN.Solutions has a network of Pharmacists with local entities

About Us

Marketing Authorisation Application Asia

Entering the ASEAN/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.

PECAN.Solutions has a network of local entities, established to help foreign companies with little or no presence in Asia, bring their products to market since 2007.

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.

Marketing Authorisation Application Asia - oral solids

Marketing Authorisation Application Asia - liquids

Marketing Authorisation Application Asia - capsules

With decades of experience in the team, we support small, medium sized and multi-national Biotech companies with

Commercial market size and potential
Regulatory intelligence, feasibility assessment, dossier gap analysis and market entry strategy
Pharmaceutical product and drug master file dossier review, preparation and product registrations
Representation as independent product registration holders (prh) or marketing authorisation holders (mah), local authorised representatives (lar)
Compliance and quality management systems,
Handling audits and qualifications
Post-marketing pharmacovigilance
Life-cycle product management and variations
Distributor search, engagement and market penetration

Our Regulatory Consulting Roadmap

Pre-market Inital assessment of registration strategy in different countries, pre-submission consultation with authorities etc

Communication with Client's RA team, Gathering, reviewing and preparation of documents for submission

PECAN.Solutions as your Virtual RA department - One central contact point with Client's RA, QA and Commercial team, to ensure registration strategy and documents required for submission to multiple countries are in order before they are passed down to the local consultants for submission

Product Registration for marketing approval

PECAN.Solutions Project
Manager to work with local consultants to obtain marketing approval

Post-marketing regulatory support, Pharmacovigilance, Import & Wholesale license application, License Holding

Post-marketing follow up with health authorities to ensure regulatory compliance and maintaining product life cycle

Our support at a glance

Diagram below shows an overview of the regulatory services we provide, incorporating regulatory strategies and product life cycle management for market access approval to different parts of Asia and rest of the world.

Strategic Regulatory Access to Markets

Regulatory Strategy & Product Lifecycle Management

Product Classification

NCE / NDA
Generics Biologics
Biosimilars
Orphan Drugs
Veterinary Medicines
Medical Devices
Advanced Drug-Device Combination Products
Cosmetics
Health Supplements
Food
TCM

Regulatory Intelligence

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

Pre-Market Submission

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