Incorporating plug in tools to facilitate publishing tasks
Single bookmarking and hyperlinking tasks were conducted manually by publishing…
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
100%
Approval by competent authorities
For over 1500 filings done by DDReg, the competent authorities worldwide have not rejected any filing to date
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
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 takenAbout 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.
Our Services
We offer a variety of world- class pharmaceutical consulting expertise, on a global scale
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
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
Our robust infrastructure and management processes ensure that dossier conversion. eCTD management and paper submissions are conducted efficiently and adhere to specific guidelines
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
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
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….
Meet our Experts
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Projects
Client Testimonial
Case Studies
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
