QUALITY

REGULATORY GCP GMP

COMPLAINCE

INTEGRITY

GCP

Complete guidance to risk based
monitoring approach

GMP

Wide range of GMP Audit services

REGULATORY

Expert regulatory service globally

Welcome to Zenovel

17

Years of Experience

With team of experts with more than 17 years of experience, Zenovel is an emerging global leader, focusing to provide one stop solution to pharmaceutical industry to help safe and effective medicine come in market with expertise in clinical research, GMP and Regulatory Affairs.  Highly preferred partner for GXP and Regulatory services across the globe.

Good Clinical Practice(GCP)

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Good Manufacturing Practice(GMP)

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Audit

Good Manufacturing Practice (GMP) audits are there to ensure that products are made in accordance with quality standards and industry best practices.

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Consulting

Designing of Procedures and SOPs, WI, Policies, Forms, Formats,
GAP Review of Quality System and Support in Improving the Documentation System

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Plant Setup & Upgradation

Conceptualisation
Facility Plan and Design or Layout
Total Engineering Support
Procurement Support

Regulatory

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Regulatory Services

We provide expert regulatory consulting services for global markets particularly in EU and US.

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Pre-Submission

Registration and self-identification i.e. D-U-N-S number, FEI number request.

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During Submission

Expert help in addressing Regulatory queries and concern like RTR, Further information request

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Post Submission

Post approval updates
Renewal of Dossier

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Why Zenovel

Ethics, quality and customer satisfaction are the prime focus in our mind. Well trained experienced staff dedicated for CGP, GMP and Regulatory services. Collective monitoring of 700 study monitoring across globe. Expertise in wide therapeutic range & regulatory like EMA, USFDA, WHO, DCGI & more.

We are happy to help. Reach us at: +91-635-635-3636 , bd@zenovel.com

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