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Regulatory Consultancy

Regulatory Consultancy - Asia
Regulatory Consultancy - Compliance
Regulatory Consultancy - Marketing Authorization
Speak with Us

  • 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

Regulatory Affairs End-to-End Support

  • Regulatory Intelligence, Roadmap & Submission Strategy

  • Feasibility Assessment & Gap Analysis

  • Pre-market Submissions, Marketing Authorization Applications

  • Product Registration and Health Authority Liaison

  • Product Lifecycle Management

  • Pharmacovigilance & Compliance

  • Due Diligence on in-license and acquisition of marketing authorization

Regulatory Consultancy - Asia
Regulatory Consultancy - Compliance
Regulatory Consultancy - Marketing Authorization

Our Experience

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 authorisation holders.

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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.

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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.

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

PharmAuth 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

PharmAuth 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

How we can help

  • Pre-submission assessment for feasibility and gap remediation to avoid lost time and high cost of unsuccessful submissions due to lack of quality or clinical data

  • Cost-effective virtual solutions

  • Regulatory Strategy for Geographic Expansion

  • Single window project management backed by team of qualified local consultants

  • End-to-end Regulatory consultation and registration submission of your products

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

  • Local language Interactions with Health Authorities (HAs)

  • Structured approach to ensure smooth and satisfactory project delivery and business continuity

Image by Austin Kehmeier

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

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

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

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

Post-Market Compliance

Post-Market Compliance

  • Post-market Surveillance and Pharmacovigilance

  • Periodic Safety Update
    Reports (PSUR)

  • Adverse event reporting

  • Variation submission

  • Gap analysis and remediation

  • Renewal applications

We provide:

  • On-site and remote regulatory consulting & support

  • Technical staff

Market Access

Market Access

  • 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

Image by John Schnobrich

Our Case Studies

  • Regulatory Roadmap covering Regulatory Intelligence, Strategies and Timeline for Registration and Product Launch

  • Regulatory Feasibility Assessment to plan order of Geographic Expansion

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