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Summary Of Monash Clinical Research

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Company Name

Monash Clinical Research

Type Of Company

Custom Research Organization

Employee Strength

5000-10000'

Key Management

Jacqui Young

Designation

Manager

Contact Number

61-39-5956111

Country

Australia

Region

Central Coast

Continent

Oceania

Company URL

https://www.monash.edu

Business Area
Products Portfolio
Buying Portfolio
Subsidiary and Affiliates
Manufacturing Locations
Certifications/ Accreditation
  • No Record Found
Competition/Peer
Financials
Patent Filed
Warning Letter By Authority
Pipeline Products
Recent News

North America
Europe
Oceania
Africa
Asia
South America
Clinical Trial
Biosimilar

Detailed Summary of Monash Clinical Research

Chemxpert provides a high-level overview of Monash Clinical Research as a company group, covering its organizational structure, leadership, operational scale, and competitive landscape.

Basic Information

The Basic Information tab captures core details that help users quickly understand the size, structure, and business footprint of Monash Clinical Research.

  • Company Name: Official legal or commonly used company group name
  • Employee Strength: Total workforce size across the company group
  • Total Number of Subsidiaries: Count of subsidiary and affiliated entities
  • Key Management: Senior leadership responsible for strategic and operational decisions
  • Designation: Official roles held by key management members
  • Business Areas: Industry segments such as APIs, formulations, chemicals, and life sciences
  • Certifications: Regulatory and quality certifications held across the group
  • Manufacturing Locations: Number of manufacturing sites globally
  • Competitors / Peers: Companies operating in similar business segments

This basic company intelligence helps users establish organizational context before exploring detailed product, regulatory, and market data.

Business Areas – Product Presence of Monash Clinical Research

This section provides a segment-wise view of Monash Clinical Research's product presence across the pharmaceutical, life sciences, and chemical ecosystem.

For each business area, Chemxpert captures the number of products associated with the company group, helping users understand its breadth of operations, strategic focus areas, and diversification level.

Industry Segments Covered

  • API – Small Molecules
  • Finished Dosage Forms (FDF)
  • Pharma Intermediates
  • Fine & Specialty Chemicals
  • Excipients
  • Cosmetic Ingredients
  • Food Industry Ingredients
  • Polymers
  • Flavors & Fragrances
  • Veterinary Actives
  • Impurities & Metabolites
  • Nutraceuticals & Dietary Supplements
  • Clinical Trial Products
  • API – Biologics & Biosimilars
  • Essential Oils
  • Dye Intermediates
  • Isotopes
  • Vaccines
  • Diagnostics & Radiopharmaceuticals
  • Chemical Intermediates

This segment-level visibility helps users assess diversification, specialization, and strategic positioning across the life sciences value chain.

Product Portfolio – Supplied by Monash Clinical Research

This section provides detailed visibility into the products supplied by Monash Clinical Research and its group entities across global pharmaceutical markets.

The data focuses on what the company manufactures and supplies to customers, helping users evaluate its commercial offerings, regulatory readiness, and supply reach.

Supplying Products – Active Ingredients (APIs)

This dataset includes detailed information on active pharmaceutical ingredients supplied by Monash Clinical Research to different countries.

It covers:

  • API names and classifications
  • Countries where the APIs are supplied
  • Regulatory and market presence associated with each API

This information supports sourcing decisions, supplier evaluation, and market access assessment.

Supplier Certifications

Captures regulatory and quality certifications held by supplying entities within the company group.

Supplying Contact Information

This section captures regulatory and quality certifications held by the supplying entities within Monash Clinical Research.

These certifications indicate compliance with national and international regulatory standards relevant to API and FDF manufacturing.

Supplying Products – Finished Dosage Forms (FDF)

Provides information on finished dosage forms supplied across global markets.

The supplying product portfolio helps users understand what {Company Name} brings to the market, across APIs and finished products, along with the certifications and contacts needed to engage with the company effectively.

Subsidiaries & Affiliates of Monash Clinical Research

This section provides detailed information on the subsidiary companies and affiliated entities operating under the company’s group.

It helps users understand the corporate structure, operational spread, and legal entities through which the company conducts its business across different regions and industry segments.

Manufacturing Locations

This section outlines the total manufacturing footprint of Monash Clinical Research across global regulatory jurisdictions.

Number of manufacturing facilities by certification type, including :

  • US FDA, EU-GMP, UK MHRA, Japan PMDA
  • Canada, Korea FDA, Brazil ANVISA
  • Australia & New Zealand
  • India CDSCO, WHO-GMP, PIC/S

Certifications & Accreditations

This section aggregates the regulatory approvals and quality certifications held across the company group and its subsidiaries.

Counts of certifications issued by:

  • US FDA, EDQM / EMA / EU-GMP
  • PMDA (Japan), TGA (Australia)
  • WHO-GMP / cGMP, MHRA (UK)
  • US-DMF, CEP / COS
  • Other regional and functional certifications

Competitors / Peers

This section provides a competitive benchmark of Monash Clinical Research against its peer. Here the total number of products held by competitors are covered across segments such as:

  • API (Small Molecules & Biologics)
  • Finished Dosage (FDF)
  • Intermediates, Excipients, Specialty Chemicals
  • Nutraceuticals, Veterinary, Diagnostics, Vaccines, and more

Use case: Enables portfolio comparison and competitive positioning analysis.

Financials

This section captures the financial performance of the Monash Clinical Research over the last three years. Here annual financial reports and key financial disclosures are provided. Which helps you evaluates financial stability, growth trajectory, and long-term supplier viability.

Patent Filed

This section summarizes the intellectual property (IP) portfolio of Monash Clinical Research across key jurisdictions.

Total patents filed and tracked by category, including:

  • US patent expiry and exclusivity
  • SPCs and Paragraph IV filings
  • Off-patent products with no generics
  • Pharma patent disputes
  • Canada data protection and patent expiry
  • India drug patents granted
  • Korea patent expiry data

Warning Letters by Authority

This section tracks regulatory actions, enforcement measures, and compliance alerts issued against the company group.

Regulatory notices and actions from:

  • US FDA (Warning Letters, Form 483, Recalls, Site Inspections)
  • EU monitoring lists
  • India CDSCO banned drugs and NPPA actions
  • WHO essential drug listings
  • NLEM (India), Orphan Drug, BTA / FTA status

Pipeline Products

This section provides visibility into the future product pipeline of Monash Clinical Research.

Products currently:

  • In clinical trials
  • Under development or pre-commercial stages

Recent News

This section captures latest, verified updates related to Monash Clinical Research.

News is categorized by:

  • Product launches and approvals
  • Certifications and accreditations
  • Clinical trial updates
  • Licensing, partnerships, mergers, and acquisitions
  • Regulatory warnings or recalls

Great. Here’s the next compact set, keeping everything brief, structured, and definition-driven.

Get detailed business insights of Monash Clinical Research –Click here

Regulatory Information – Active Ingredients (API)

This section provides regulatory filing, registration, and market authorization intelligence for APIs supplied or manufactured by Monash Clinical Research.

Data Covered API regulatory filings and approvals across major regions, including:

  • US DMFs and FDA-NDC listings
  • CEP/COS and EU API registrations
  • Written Confirmations (India–EU)
  • REACH registrations
  • UK MHRA approvals
  • J-DMF (Japan) and K-DMF (Korea)
  • Import licenses and API registrations across India, China, Egypt, and other regions

Use case: Supports regulatory due diligence and global market entry planning.

Regulatory Information – Finished Dosage Forms (FDF)

This section tracks FDF-level filings, registrations, and market authorizations for products manufactured or marketed by Monash Clinical Research.

FDF registrations and approvals across:

  • North America
  • Europe
  • Asia
  • Oceania
  • Africa
  • South America

Clinical Trial Activity

This section captures ongoing and historical clinical trials conducted by Monash Clinical Research.

Number of clinical trials across:

  • United States
  • Europe
  • Japan
  • Canada
  • South Korea
  • India
  • Australia and New Zealand

Use case: Indicates R&D intensity and development focus across regions.

Biosimilar Portfolio

This section provides an overview of the biosimilar development and commercialization footprint of the Monash Clinical Research.

Biosimilar products and regional presence across:

  • United States
  • Canada
  • Europe
  • Latin America (Argentina, Brazil)
  • Asia (India, China, South Korea, Japan, Malaysia)
  • Australia

Get detailed Monash Clinical Research Regulatory Information on active ingredients filing/registration/market authorization.Click here

Why Choose Chemxpert?

Explore deeper, verified intelligence with Chemxpert, the no. 1 global pharma database. Whether you are evaluating suppliers, benchmarking competitors, planning regulatory filings, or assessing market opportunities, Chemxpert gives you a single, structured view of global pharma data, from APIs and FDFs to patents, clinical trials, and compliance signals.

  • Access molecule-level and company-group intelligence
  • Reduce due-diligence time and sourcing risk
  • Make faster, data-backed strategic decisions

Discover the full Chemxpert dataset and start analyzing with the right data to make the right decisions.