Your End-to-End Regulatory Partner

Our Regulatory Expertise

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

Regulatory Consultancy Services

01

02

03

04

05

06 Our Regulatory Consulting Roadmap

Our Comprehensive Service Framework

Strategic Regulatory Access to Markets Regulatory Strategy & Product Lifecycle Management

Product Classification Expertise

Regulatory Intelligence Services

Pre-Market Submission Services

Post-Market Compliance Management

Market Access Solutions

Our Service Delivery Model

Flexible Support Options

Why Choose PECAN.Solutions for Regulatory Consultancy

Ready to Navigate Asian Regulatory Markets?

Strategic Intelligence & Planning

Pre-Market Assessment & Strategy

Marketing Authorization Applications

Product Registration & Authority Liaison

Lifecycle Management & Compliance

Due Diligence & Licensing

Regulatory Consultancy Asia

Regulatory Affairs End-to-End Support

Proven Local Regulatory Infrastructure

Complete Commercial Access Solutions Across All Healthcare Categories

End-to-End Regulatory Affairs Support

How We Guide You to Market Success

Your Competitive Advantage in Asian Regulatory Markets

Let's Build Your Regulatory Strategy

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 Regulatory Consultancy Asia Your End-to-End Regulatory Partner Regulatory Affairs End-to-End Support Navigate Asia's complex regulatory landscape with confidence. Our regulatory consultancy provides comprehensive end-to-end support from pre-market strategy to post-market compliance, backed by local entities with audited Quality Management Systems across ASEAN markets.

Our Regulatory Expertise Proven Local Regulatory Infrastructure Audited Quality Management Systems & Local Entities

We have our own local entities and network of entities, under our qualified and audited Quality Management Systems by local authorities as well as by European clients, ensuring compliance with local Good Distribution Practices as well EU Pharmacovigilance to support as local marketing authorization holders.

Our team of consultants are locally hired with native language capabilities, backed up by Project Managers, ensuring project reliability, assured delivery and business continuity without disruption in case of absenteeism due to sickness or resignation.

We have combined decades of experience dealing with all the different product categories and are effective communicators with the local health authorities to support product registration and life cycle management as well as post-marketing Pharmacovigilance.

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:

Regulatory Intelligence, Roadmap & Submission Strategy

• 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 and Quality Assurance

Feasibility Assessment & Gap Analysis

• Pre-submission assessment for feasibility and gap remediation

• Preclinical, clinical data and dossier requirements

• Approval pathways and lead time analysis

• Registration fee guidance

• Pricing and reimbursement policies

Pre-market Submissions, Marketing Authorization Applications

• Project Management and engagement of subject matter experts

• Module 1 Application preparation

• eCTD / ACTD conversion, preparation and submission

• Country specific dossier and labeling translation

• Compliance review and assembly

• Master files compliance evaluation

• CMC review

Product Registration and Health Authority Liaison

• Submission filing to local regulatory agencies

• Regulatory agency meetings and feedback management

• Reimbursement application support

• GMP and GDP audit inspections

Product Lifecycle Management & Pharmacovigilance & Compliance

• Post-market Surveillance and Pharmacovigilance

• Periodic Safety Update Reports (PSUR)

• Adverse event reporting

• Variation submissions

• Gap analysis and remediation

• Renewal applications

Due Diligence on in-license and acquisition of marketing authorization

• Marketing Authorization Holder applications

• Establishment registration

• Manufacturer site inspections

• Import License applications

• In and out licensing support

• Transfer of license management

• Product License holding and protection

• Technology Transfer facilitation

Our Regulatory Consulting Roadmap Phase 1:

Pre-Market Assessment

Initial assessment of registration strategy in different countries

• Pre-submission consultation with health authorities

• Regulatory intelligence gathering

• Market feasibility analysis

Phase 2:

Preparation & Strategy

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

• Dossier compilation and review

• Multi-country submission strategy

• Risk assessment and mitigation planning

Phase 3:

Virtual RA Department

PECAN.Solutions as your Virtual RA department

• One central contact point with Client's RA, QA and Commercial teams

• Ensuring registration strategy and documents required for submission to multiple countries are in order

• Coordination before documents are passed to local consultants for submission

Phase 4:

Product Registration

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

• Professional submission management

• Health authority liaison and communication

• Timeline management and progress reporting

Phase 5:

Post-Marketing Support

Ongoing regulatory support, pharmacovigilance, import & wholesale license applications, license holding

• Post-marketing follow up with health authorities

• Ensuring regulatory compliance and maintaining product life cycle

• Variation submissions and renewals

We provide expert guidance across all pharmaceutical categories:

NCE / NDA

Generics Biologics

Biosimilars

Orphan Drugs

Veterinary Medicines

Medical Devices

Advanced Drug-Device Combination Products

Health Supplements

Food

TCM

Our comprehensive regulatory intelligence includes:

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

We manage every aspect of your market entry:

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

Ongoing support includes:

Post-market Surveillance and Pharmacovigilance

Periodic Safety Update Reports (PSUR)

Adverse event reporting

Variation submission

Gap analysis and remediation

Renewal applications

We facilitate complete market access through:

Marketing Authorization Holder Application

Establishment Registration

Manufacturer Site Inspection

Import License Application

In and out licensing

Transfer of license

Product License holding and protection

Technology Transfer

We provide comprehensive support through:

On-site regulatory consulting & support

Direct presence when needed

Remote regulatory consulting & support

Efficient virtual collaboration

Dedicated technical staff

Specialized expertise for your projects

Audited Local Infrastructure

Local entities with Quality Management Systems audited by local authorities and European clients, ensuring full compliance with local GDP and EU Pharmacovigilance requirements.

Native Language Capabilities

Locally hired consultants with native language capabilities, backed by experienced Project Managers for reliable delivery and business continuity.

End-to-End Regulatory Solutions

From initial market assessment to post-marketing compliance, we provide complete regulatory consultancy services under one roof.

Cost-Effective Virtual Solutions

Single window project management backed by qualified local consultants, providing expert regulatory support without in-house overhead.

Health Authority Relationships

Effective communicators with local health authorities across Asia, ensuring smooth product registration and lifecycle management.

Structured Project Delivery

Proven approach ensuring smooth and satisfactory project delivery with business continuity safeguards.

Don't let regulatory complexity delay your Asian market entry. Our regulatory consultancy team, backed by audited local entities and decades of experience, is ready to guide you through every step of the regulatory process across Asia's diverse healthcare markets.

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.