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.

Schedule Your Regulatory Consultation

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.

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

Regulatory Consultancy Services

End-to-End Regulatory Affairs Support

01

Strategic Intelligence & Planning

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

02

Pre-Market Assessment & Strategy

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

03

Marketing Authorization Applications

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

04

Product Registration & Authority Liaison

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

05

Lifecycle Management & Compliance

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

06

Due Diligence & Licensing

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

How We Guide You to Market Success

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

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

We provide expert guidance across all pharmaceutical categories:

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

Our Service Delivery Model

Flexible Support Options

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

Why Choose PECAN.Solutions for Regulatory Consultancy

Your Competitive Advantage in Asian Regulatory Markets

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.

Ready to Navigate Asian Regulatory Markets?

Let's Build Your Regulatory Strategy

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.

Schedule Your Regulatory Consultation