ABOUT US

Who We Are

“DDReg – since its inception in 2009 has proven to be the trusted partner of the leading Pharmaceutical Companies to manage their regulatory affairs portfolio by way of Regulatory Advisory on Entry Strategies, Technical compliances andrequirements, Feasibility Studies, Dossier compilation & submissions. We’re also an astute partner who can help simplify that journey for our clients to get the registration of their product more quickly. We aim to provide quality with passion”

DDReg is an India based Regulatory and Drug Safety Services organization. It is ISO 9001:2015 certified by TUV-SUD for its Quality Management System. It is involved in a wide variety of regulatory consulting, advisory & operational assignments which span across global markets that include key markets like USA, UK & European Union, ASEAN and Africa.

DDReg has, rich experience of handling ANDA and ANADA filings to US FDA as well as DCP/MRP procedures in EU. The working level teams at DDReg have carried out extensive due diligence activities of technical documents, gap analyzed the documentation, developed and authored the CTD Modules for submission to FDA, EMA & UK MHRA, published eCTD modules using established publishing tool and have submitted the dossier & applications using electronic submission gateway. DDReg is consulting partner to Extedo (Munich, Germany).

DDReg has helped pharmaceutical companies to manage their regulatory affairs portfolio by way of Regulatory Advisory on Entry Strategies, Technical compliances and requirements, Feasibility Studies, Dossier compilation & submissions, Agency follow ups, approvals. It has successfully supported organizations for their requirement of Post Approval Life Cycle Management by managing post approval Compliances, Gap Analysis and Regulatory due diligence. DDReg’s Product Scope so far include Generic Pharmaceuticals (Human Drugs), Generic Pharmaceuticals (Veterinary Drugs), Cosmetics and some Food supplements.

DDReg has processes par excellence, Committed bunch of RA Professionals and efficient IT systems & databases for dossier management & submission

Functional Expertise stands tall on Standard Operating Procedures & Working Guidelines that define global RA standards. Processes are in place for consistent monitoring & tracking of global RA Regulations/Guidelines (US FDA Guidance, EMA regulations, WHO, ICH, African & ASEAN RA Practices)

Operational Excellence is manifested through strong Quality Management System, and Efficient Project Management. In span of 9 years DDReg has carried out Regulatory Due Diligence of about 500 dossiers, resulting in successful submissions, approvals and launches for its esteemed clients.

DDReg is led by Experts with combined experience of ~ 60 years in handling product development, RA & Medical writing work. Efficient Structure with experienced groups handling each stage of product life cycle, is the hallmark of human resource at DDReg. Extensive trainings on all critical aspects of RA (e.g GMP – PIC/s, WHO, Quality Monitoring, Dossier Management, Medical Writing, ICH requirements etc.) are provided to the staff. DDReg has well developed training Calendar to enrich the technical knowledge of its technical team.

It was founded by Ms Neeti Pant, she worked in the scientist position with one of the top pharmaceutical company. DDReg was established with ardour to bring together regulatory, safety, medical, and technology resources.

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History

DDReg was established in 2009 Started as DDReg Pharma Regulatory Solutions as Sole Proprietary Company. The organization was established with the in-depth pharmaceutical company expertise. It was started with the single person organization from a home based office and with 12 months of it sinitiation, it grew big enough to have its own office set up. Within first three years of its initiation, the organization was incorporated as company, grew in noemployees and clientele, certified ISO 9001:2008 for its QMS. Later in 2013, its Life Science vertical was started for providing Drug Safety Services. DDR egbecame consultant partners to Extedo – Germany. In 2016 DDReg was certified ISO 9001:2015 by TUV SUD. DDReg open its new branch in Mumbai in 2018.

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WHY DDREG?

DDReg develop Regulatory Strategies, provide expert Regulatory advice right from product development stage upto launch, dossiers compilation & publishing, post approval market maintenance. Besides Regulatory services DDReg also offers a complete range of Pharmacovigilance and Medical Writing services to its clients. At DDReg we manage a Regulatory Affairs or Pharmacovigilance project regardless of size and timescale. From filing submissions to the more complex management of compliance issues, post-licensing activities on one side and form Adverse event processing to complicated Signal detection in Pharmacovigilance on the other side, we are the experts and can supply the desired expertise to match any Regulatory Affairs / Pharmacovigilance need – anywhere in the world.

There are many good reasons as to why some of the leading global pharmaceutical organizations prefer DDReg as their partner, the key ones are highlighted as below

Quality

Delivery of Quality Services which stretch beyond scopes agreed.

Value

Cost advantage but with top class quality.

Leadership

Highly respected technocrats leading the business.

Efficiency

Efficient service models customized to client requirement.

Our Vision

To provide regulatory solutions of highest quality, in a cost efficient manner, to organizations, manufacturing marketing pharmaceuticals and allied products, to enable them expand their businesses in developed and emerging markets.

Our Mission

To achieve INR 500 Mn revenue by being valued partner of Pharmaceutical Organizations for global regulatory services!

OUR VALUES

Our values are important part of our establishment, they are considered for every decision that we make. Our values reflect in our work and the way we handle the assignments. Our values have stayed strong have kept our team together. Our belief in our value system have remained from since the time when the organization grew from a single person premise to where it is now - an established organization

It is our values that make our team together as it was started from a single person premise to an established organization.

Quality

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Integrity

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Excellence

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Commitment

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Teamwork

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Quality Certification

DDReg Pharma Pvt Ltd and DDReg Life Sciences Pvt Ltd have been certified for its QMS under ISO 9001:2015 by TUV:SUD.

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