G M P - Documentation

G2 Business Excellence Consulting

Core Competencies

Our core competencies are our regulatory and drug development expertise coupled with
our technical document and submission expertise (CRO services) and internal quality
driven processes. This is reflected in our ability to understand the data, identify the risks
and benefits, and translate the assessment into documents that address health authority
requirements and potential concerns while supporting the sponsor's objectives.

Regulatory Strategy With CRO and Submission Services

Our services include project planning, submissions support, CRO services, and regulatory
strategy. Select the services you need depending on your requirements for external
support. All services are provided under the Hurley Consulting quality system. We are
large enough to have the necessary breadth of expertise, and small enough to focus on
each of our clients personally.

Quality System

Our services are consistent, reproducible, and conducted using documented processes.

Based on your needs, our work is conducted according to our SOPs, your SOPs, or using
an interface that documents whose SOPs certain activities are conducted under as a
closed quality system.

Philosophy

We are committed to quality and timely services to support our clients.

w: www.generationnext.in | t: +91 8076524311| e: g2businessexcellence@gmail.com

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