Clients

(Customers)

GlobeX Services

Incentives

 GlobeX is ideally located (NJ, US) to provide product development services to Clients (especially in US & EU) to lesson their materials

supply chain issues in a cost effective, timely manner without impacting quality and lead-times.

 GlobeX services team is highly experienced and provides a risk-free approach to clients on their day to day product development

services while working with CROs/CDMOs around the world.

 GlobeX has the network of reliable, well established, reputable and cGMP complied CROs/CDMOs from across the world.

 GlobeX validates cGMP compliance in supplying the materials based on Clients phase appropriate projects development requirements

(phase 1, 2, 3 & commercial)

 GlobeX conducts CROs due diligence on behalf clients and identifies their suitability to supply materials to Clients based on

their reputation, in market standing, history of their reliability, cost, financial strength, quality, regulatory auditing compliance.

 GlobeX can provide alternative choices to existing materials suppliers (CROs & CDMOs) issues with new cost effective, robust &

sustainable supply chain mechanism while maintaining the quality, regulatory compliance and lead-times.

 GlobeX confirms/inspects CROs have suitable regulatory DMFs (USDMFs, EUDMFs, SEP etc.) in place prior to supplying APIs to clients

for routine drug product manufacture and marketing in US and EU.

 GlobeX identifies new CROs for custom synthesis of KSMs/RSMs to lower the cost of APIs to increase their profit margins.

 GlobeX coordinates CROs are complied with quality assurance & to change management principles for the materials they manufacture.

 GlobeX team consists of 75+ years of rich experience & achievements in pharmaceutical industry in managing products development

in technical, analytical, manufacturing, regulatory compliance, submissions INDs, NDAs, MAAs, ANDAs, quality inspections & business

Why GlobeX?

What

Where

Because of….

GlobeX services

differs from others !

Globex Activities/Services

 GlobeX assumes one-stop shop for customers quality need in procuring the APIs, intermediates

& RSMs/KSMs.

 Assumes to provide cost effective source of APIs for early to late stage development and for

commercialization

• GlobeX Quality audits suppliers manufacturing sites & ensures the cGMP compliance to align

with regulatory expectations.

• Ensures the APIs GMP stability protocols followed, and shelf life assigned appropriately.

• Ensures the suppliers meet local environmental compliance in materials production at their

site.

• GlobeX ensures the letters of GMP compliance to Client for clinical studies and regulatory

filings i.e. DMFs, INDs, NDAs, ANDAs etc.

• Ensures suppliers adheres to the regulatory guidelines' technical guidance in materials

development.

• Inspects the suppliers master batch records for GMP compliance in producing the materials

(APIs, intermediates, RSMs etc.).

 GlobeX works with suppliers quality assurance group to adhere to Global GMP compliance and

guidances.

 GlobeX helps Customers (Clients) to identify robust APIs supply chain to their project needs.

 GlobeX identifies Custom synthesis for KSMs/RSMs

 GlobeX works with suppliers and Clients to assign KSMs/RSMs for APIs synthesis and helps in

securing the designation from regulatory bodies i.e. FDA, scientific advisory board etc

 GlobeX coordinates the delivery of APIs to Clients on time and within budgets with necessary

documents from suppliers.

 Globex alerts any cGMP compliance issues from suppliers to Clients

 Globex manages APIs inventory with suppliers and Clients

 GlobeX ensures the APIs specification meet for clinical and commercial deliveries.

 GlobeX helps in developing appropriate APIs and intermediates specifications for the projects

based on the stage of development.

 Globex ensures appropriate analytical validation methods developed & implemented in

analyzing APIs, intermediates, RSMs/KSMs etc. via stability indicating methods are in place.

 GlobeX coordinates and resolves any Customer complaints for the shipped materials (APIs,

intermediates, RSMs/KSMs).

 GlobeX ensures suppliers had appropriate Global cGMP certifications accreditation prior to

purchasing the materials.

Suppliers

(Manufactures,

Partners)

Clients

(Customers)

Current Partner Suppliers

 Nosch Labs, India

 Ceyone Life Sciences, India

 GVK biosciences, India

 Erthyro Pharma, India

Potential future Suppliers

 Devis Lab, India

 Suven Life Sciences, India

 Piramal, India

• Neuland, India

• Zydus lab, India

• Dr Reddys lab, India

• MSN Labs, India

• Cipla, India

• Aravindo, India

• Hetero Drugs, India

Potential Clients ?

 Merck, USA

 Watson Lab, USA

 Teva, USA

GlobeX offers highly

experienced & skilled

chemistry team to clients

need in cost effective &

risk-free approach !