USA
India
Germany
Singapore
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 MOREDeep 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 MOREWe 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 MORESolutions, best practices, high end automation tools and infrastructure that address challenges you face in submission and publishing management.
KNOW MOREEnd 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 MOREExpert 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 MOREOur collaboration with patent attorneys with more than 20 years of experience enables effortless delivery of product launches, market authorizations and regulatory filings.
KNOW MOREYour 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
authorities
For over 1500 filings done by DDReg, the competent authorities worldwide have not rejected any filing to date
Filings in Regulated & Emerging Markets
Since its inception in 2009 – DDReg has done more than 2000 filings and the number is growing
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.
As a leading regulatory consulting firm, we assist our life sciences clients in expediting their revenue growth by delivering extensive regulatory consulting support to facilitate rapid pharmaceutical product registrations in global markets. We ensure ongoing regulatory compliance throughout the entire lifecycle of their pharmaceutical products.
Our success is attributed to a combination of subject matter expertise, technical skillset, innovation, and profound knowledge of pharmaceutical regulatory affairs. This amalgamation allows us to support our customers with high-quality regulatory and pharmacovigilance services, providing them with the assurance that their pharmaceutical products are managed with precision and adherence to regulatory standards across product lifecycle.
As a leading regulatory consulting firm, we have provided our life sciences customers with end-to-end pharmacovigilance and regulatory solutions catering to their unique requirements and target markets. Partner with us today for unparalleled excellence in regulatory and pharmacovigilance services.
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 moreWe offer a range of drug safety and regulatory consulting services that are compliant with global regulations. We have supported our customers for their extensive portfolios including generics, biologics, biosimilars, medical devices, combination products, vaccines, consumer products and more. We specialize in navigating complex regulatory landscapes, ensuring compliance, and accelerating approvals. Trust us for expert guidance in regulatory affairs and pharmacovigilance, streamlining processes for seamless submissions. Gain a competitive edge by partnering with us for efficient and compliant regulatory solutions.
Decision making driven through smart tech platforms that integrate rich subject matter expertise and technology
Operational Excellence Efficient in-house templates automated to address harmonization across teams leading to quality & consistency in delivery
Over 12 years of strong reference base to 100+ Regulatory Agencies
Aligning precise & pre-emptive Reg Strategies with business objectives to gain rapid market access
Elevate your regulatory and compliance endeavors with our regulatory consulting expertise. Unleash innovation and accelerate success by partnering with us as your trusted regulatory consulting firm.
Fast-track your regulatory submissions and enhance your life sciences ventures with our industry-leading regulatory consulting services. As the foremost regulatory and pharmacovigilance service provider, we excel in regulatory approval consulting, ensuring swift and compliant pathways for your products. The synergy of our team of seasoned professionals and innovative approach distinguishes us in the realm of regulatory consulting. Rely on our expertise to streamline processes that guarantee efficient submissions.
With a proven track record, we stand as the pinnacle in regulatory consulting services, offering unparalleled support for regulatory approval consulting. Partner with us to propel your success, secure rapid approvals, and surpass industry standards with confidence.
Need to get in touch with us? Either mail us on given email id or you can directly call us on our given number
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.
