Regulatory Services in Mexico
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Regulatory Services in South Africa100%
Success Rate with competent
authorities
For over 1500 filings done by DDReg, the competent authorities worldwide have not rejected any filing to date
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
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...
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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...
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Publishing
Our robust infrastructure and management processes ensure that dossier conversion. eCTD management and paper submissions are conducted efficiently and adhere to specific...
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Labeling
We provide updated labeling and compliance packages, that assist in the development of Product Labeling, Artwork Review & Compliance and Claim Substantiation...
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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...
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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.
