DDReg Pharma

ISO 9001:2015 & ISO 27001:2013

WE ARE CERTIFIED

We are committed towards providing high quality services to our customers and prioritizing information security that is accredited by the TÜV SÜD certification.

Deliver better data to ensure faster approval

Tool that combines Regulatory Project management, Document Management and Regulatory Information together in one package, that helps in preparing, tracking and monitoring a top quality submission package as per market requirements

DDReg is your trusted partner for Rapid Market Access

With right blend of experience, skillset, innovation and technology we bring differentiation and focus to give you quality with speed

Real Results Immediate Value

Approval

100%

Approval by competent authorities

For over 1500 filings done by DDReg, the competent authorities worldwide have not rejected any filing to date

Filings in Regulated

1635+

Filings in Regulated & Emerging Markets

Since its inception in 2009 – DDReg has done more than 1635 filings until 2020 and the number is growing

Focus & Effort

100%

Right-first-time

The focus & effort is to do “right first time” filing in 100% of the cases. However, sometimes, based on customer’s needs, a risk-based approach is also taken

About Us

We help our life sciences customers in accelerating their revenue growth by driving fast track registrations in global markets and maintaining regulatory compliance through the life of their products. With the right blend of experience, relationships, skill, innovation and in-depth expertise in pharmaceutical regulatory affairs, we bring top quality regulatory services to our clients.

Regulatory Services

Our Services

We offer a variety of world- class pharmaceutical consulting expertise, on a global scale

Regulatory

Regulatory

Our regulatory services can help devise tailored strategies, provide technical processes and on-going support in Due-Diligence, Gap Analysis, New Product Authorizations and more

Pharmacovigilance

Pharmacovigilance

We optimize safety databases and technical ability to deliver high-quality and reliable safety measures with minimal risk across ICSR Processing & Submission and have global presence in providing PV support

Publishing

Publishing

Our robust infrastructure and management processes ensure that dossier conversion. eCTD management and paper submissions are conducted efficiently and adhere to specific guidelines

Labelling

Labelling

With experts having prior experience of working on range of pharmaceutical & biological products, we provide updated labelling and compliance packages, that assist in the development of Product Labelling, Artwork Review & Compliance and Claim Substantiation

Medical Writing

Medical Writing

The highly experienced medico-writing team have developed procedures and templates to ensure the modules of CTD are detail-oriented and additionally provide expertise in Bio Waiver Justifications and Well Established Use

IPR Support

IPR Support

Our collaboration with patent attorneys, with more than 20 years of experience, enables effortless delivery of product launches, market authorizations and regulatory filing

DDReg Differentiators

Speed, Quality, Excellence, Technology, Teamwork & many more….

Reg Tech Advantage Decision making driven through smart tech platforms that integrate rich subject matter expertise and technology
Operational Excellence Operational Excellence Efficient in-house templates automated to address harmonization across teams leading to quality & consistency in delivery
Precise & Pre-emptive Reg Strategy Aligning precise & pre-emptive Reg Strategies with business objectives to gain rapid market access
Rich Experience with Global Agencies Over 12 years of strong reference base to 100+ Regulatory Agencies

    Meet our Experts

    Neeraj Pant

    Neeraj Pant

    MPHARM, MBA

    Dr. Lokesh Pant

    Dr. Lokesh Pant

    MBBS, MD, IMS BHU

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    Clients

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    Year of Experience

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    Projects

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    Clients

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    Year of Experience

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    Projects

    Client Testimonial

    - One of the top 5 Indian pharma companies

    We have been associated with DDReg for about 6 years. We would recommend DDReg to all cos requiring outsourced regulatory services. They are highly reliable, provide good quality dossiers, which is worth the value they charge for the services.

    - A UK based global CHC organization.

    We are very satisfied with the Regulatory services provided by DDReg. DDReg services meet our regulatory outsourcing needs extremely well. The team at DDReg is very responsive and provide high-quality deliveries. We are delighted to have DDReg as our partner and it is extremely likely that we shall recommend DDReg to other companies within our network.

    - An EU headquartered generic Animal Health Products organization

    DDReg is a regulatory service provider that is engaged in high-quality regulatory services. They are a very professional service provider with a great deal of regulatory expertise in the area of Animal Health Products. The company has been very responsive and useful to our needs for US and EU filings of Animal Health Products.

    - A UK based global female product NGO.

    DDReg services meet our regulatory outsourcing needs extremely well. DDReg provides high-quality regulatory services that meet our requirements extremely well. The team works professionally and is sensitive to 'On time' delivery. We are delighted to have DDReg as our regulatory partner.

    - A Spain based generic pharma company

    We are Spain based generic pharma company. We used DDReg for regulatory services for EU markets. Outsourcing the RA services proved very beneficial for us. We are very satisfied with DDReg's services.

    - One of the top ten Indian Pharma companies

    We are extremely happy with DDReg's medical writing work. Their high-quality work on the authoring of CTD clinical & non-clinical sections have helped us getting several MAs in EU and ROW markets.

      Case Studies

      Incorporating plug in tools to facilitate publishing tasks

      Single bookmarking and hyperlinking tasks were conducted manually by publishing…

      Legibility checks to avoid ANDA rejection

      A U.S.-based manufacturer had deficiencies in their abbreviated new drug…

      Gulf Health Council file upload for biosimilar product

      One of the top three biopharmaceutical companies approached DDReg to…

      Global Reach & Presence

      Gloval Precense
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