Introduction

DDReg is an India based Regulatory and Drug Safety Services company.The company has been certified by TUV-SUD for ISO 9001:2015 Quality Management System. It is involved in a wide variety of regulatory Pharmacovigilance (PV) assignments from organizations across the globe for Regulated and Emerging Markets. DDReg was established in 2009 –Starting as DDReg Pharma Regulatory Solutions as Sole Proprietary Company. The organization was established with the in-depth expertise in pharmaceutical regulatory affairs and drug product safety functions.

Envisioned by Neeti Pant – an alumnus and gold medalist of IIT-BHU, the organization boasts to serve some of the big names in global pharmaceutical industry with offices in Gurgaon and Mumbai.with the motto of “Quality driven by passion” DDReg is improving its “Preference Share” within pharmaceutical sector.

Growth Continuum

2009

2010

2011

2012

2013

2014

2015

2016

2017

2018

Founding of DDReg – Started as DDReg Pharma Regulatory Solutions as Sole Proprietary Company

Successful completion of DDReg’s first major project utilizing our expert knowledge in European Regulatory Affairs resulting 3 MAs in UK
Establishment of DDReg Website
Initiation of RA work for Emerging Markets

Expansion of DDReg Team, IT systems and QMS
Exponential Business Growth

Completed 100 filings across EU and Emerging Markets
DDReg Pharma Pvt Ltd. – The Regulatory Affairs Consulting Company was created
Underwent ISO 9001:2008 audit

ISO 9001: 2008 Certification of DDReg Pharma Pvt Ltd
DDReg Life Sciences Pvt Ltd. – The Pharmacovigilance & Medical Writing CRO was created

DDReg Group company established with state of the art new Office
DD Qualia Med Pvt Ltd – DDReg’s Product Supply arm created

Cleared Audits to comply EU regulations for Drug Safety Services & went into Production

Received 2nd ISO 9001:2008 certification from TUV-SUD

Reached critical mass for Businesses & growth journey continues
Envisioned the entry into generic products for exports

Opened DDReg branch in Mumbai
DDReg Pharma Pvt Ltd and DDReg Life Sciences Pvt Ltd certified ISO 9001:2015 by TUV-SUD

What We DO?

Regulatory Consulting & Strategy

Assessments & Gap Analysis

Drug Product Authorizations

Post Approval Life Cycle Management

Drug Safety/Pharmacovigilance

Regulatory & Medical Writing

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“Many people who try to do big bold things in the world findout it's not about the money or the technology: It's aboutthe regulatory hurdlesthat will try and stop you.”

Peter Diamendis

Entrepreneur, Engineer, Physician & founder chairman of X Prize Foundation

I would think that to say regulations cost jobs or regulations create jobs is too simple, and we need to look at the regulation.

Cass Sunstein

Former Administrator of the White House Office of Information and Regulatory Affairs in the Obama administration

What makes us different?

There are many good reasons as to why some of the leading globalpharmaceutical organizations prefer DDReg as their partner. It is DDReg’sdomain expertise, technical competence spiced up with values of commitment,Integrity, teamwork excellence served on quality platter garnished with costefficiency that makes DDReg’s service recipe different from “others”.

Quality

By quality, we mean more than just services meeting our ownspecifications. It means meeting customers requirements and ensuring quality in all dealings with our customers.... Read more

Integrity

We display integrity at all times in the business decisions wemake, the work we do and the manner in which we conduct our Business.... Read more

Excellence

We are passionate about people, process, product, and service excellence. We are determined to serve our customers through vastmost updated knowledge base.... Read more

Teamwork

We support that sense of doing what’s right through a culture ofopen communications and a spirit of teamwork.... Read more

Commitment

We are committed to providing value to our clients and to those colleagues who rely on us for Quality Excellence.... Read more

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