100%
Success Rate with competent
authorities
For over 1500 filings done by DDReg, the competent authorities worldwide have not rejected any filing to date
We are leading global regulatory consulting & services organization
DDReg Pharma is a global regulatory consulting and strategic product development firm dedicated to maintain the control of your pathway and stay ahead of any compliance risks.
KNOW MORERegulatory Services
Rich experience of 130+ countries
Deep subject matter expertise in developing customized regulatory strategies, due-diligence, gap analysis, CTD compilations, New product authorizations (Drug Substance & Drug Products), CMC advisory and much more
KNOW MOREPharmacovigilance Services
Your trusted partner in Safety Compliance
We deliver high-quality and reliable pharmacovigilance measures. We manage your safety processes through efficient ICSR processing, Aggregate reports, Signal Management, Product RMPs, SDEAs, PSMF and PV SOPs and ensure your safety compliance to global agencies including EMA, FDA, UK MHRA, Health Canada and many more!
KNOW MORESubmission & Publishing Services
Submission & Publishing expertise driven by technology
Solutions, best practices, high end automation tools and infrastructure that address challenges you face in submission and publishing management.
KNOW MORELabeling Services
Labeling & Artwork Management Expertise
End to end product labeling services – Label development, Structured product labeling, Label review process, Artwork management for range of products including prescription pharmaceuticals – small molecules & biomolecules, Consumer Healthcare products, Medical devices and regulated consumer products.
KNOW MOREMedical Writing Services
We embrace your complexity of medico-regulatory writing needs!
Expert medico-regulatory-writing team that is focused on drafting, compiling, and reviewing eCTD modules, Clinical reports as well as developing SPC, PIL, PADER, RMP, clinical study protocols and devising biowaiver justifications and agency query responses.
KNOW MOREIPR Services
We unwrap the Patent & other IPR challenges for your markets
Our collaboration with patent attorneys with more than 20 years of experience enables effortless delivery of product launches, market authorizations and regulatory filings.
KNOW MOREDDReg is a Global Regulatory Consulting and Services Provider
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
Success Rate with competent
1700+
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 taken
Who we are
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
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...
Learn 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...
Learn more
Publishing
Our robust infrastructure and management processes ensure that dossier conversion. eCTD management and paper submissions are conducted efficiently and adhere to specific...
Learn more
Labeling
We provide updated labeling and compliance packages, that assist in the development of Product Labeling, Artwork Review & Compliance and Claim Substantiation...
Learn more
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...
Learn more
IPR Support
Our collaboration with patent attorneys, with more than 20 years of highly experience, enables effortless delivery of product launches, market authorizations and regulatory filing...
Learn moreSpeed, Quality, Excellence, Technology, Teamwork & many more…
DDReg Differentiators
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
Rich Experience with Global Agencies
Over 12 years of strong reference base to 100+ Regulatory Agencies
Precise & Pre-emptive Reg Strategy
Aligning precise & pre-emptive Reg Strategies with business objectives to gain rapid market access
Enquire Now!!
Need to get in touch with us? Either mail us on given email id
or you can directly call us on our given number
What Our
Clients Have To Say
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.
One of the top 5 Indian pharma companies
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.
A UK based global CHC 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.
An EU headquartered generic Animal Health Products organization
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.
