DDReg Pharma Pvt Ltd

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DDReg Pharma Pvt Ltd

Incepted in the year 2009, the company is involved in a wide variety of regulatory & drug safety assignments which span across global markets.

DDReg is a global life sciences consulting firm specializing in regulatory affairs, pharmacovigilance, and quality services, accelerating product registrations and ensuring compliance through smart RegTech and deep industry expertise. Rich subject matter expertise gets combined with cutting edge technology solutions providing end to end support across pharma value chain. The company supports global pharmaceutical organizations for their needs to address regulatory challenges pertaining to Biologicals, Complex formulations, INDs, NDAs and Generics, Consumer Healthcare products and Medical Devices, in highly regulated markets as well as in complex emerging markets. The services portfolio includes Document management, Dossier support, pre-Approval and Post MA regulatory support, Submission management, Regulatory Intelligence, Regulatory Strategies, Feasibility Studies, Dossier compilation, submissions, Agency follow ups and approvals. The Drug Safety Vertical supports global organizations to manage their worldwide Safety Obligations by way of Case Management, Aggregate Reporting, Safety Compliances, Signal Detection and Risk Management. Functional and Operational Excellence are manifested through Strong Quality Management System, and Efficient Project Management.

28/10/2025

𝐃 = 𝐃𝐞𝐧𝐦𝐚𝐫𝐤 in our Global Regulatory A–Z series.

𝐌𝐞𝐞𝐭 𝐭𝐡𝐞 𝐃𝐊𝐌𝐀 (𝐃𝐚𝐧𝐢𝐬𝐡 𝐌𝐞𝐝𝐢𝐜𝐢𝐧𝐞𝐬 𝐀𝐠𝐞𝐧𝐜𝐲):
Headquartered in Copenhagen, the DKMA oversees medicines, medical devices, clinical trials, and pharmacovigilance. Beyond local leadership, it plays a key role in EU harmonization and device regulation.

💡𝑫𝒊𝒅 𝒚𝒐𝒖 𝒌𝒏𝒐𝒘? DKMA’s influence in EMA committees and device frameworks makes Denmark a strategic market for life sciences companies aiming for European alignment.

With expertise in submissions, PV compliance, and dossier strategies, we help companies navigate the Danish and EU regulatory landscape with confidence.

Discover More: https://lnkd.in/d4BPUY-v

27/10/2025

The 1906 U.S. Pure Food & Drugs Act marked the moment drug oversight became a scientific discipline. It set the framework for how governments protect quality, ensure transparency, and build patient trust in every medicine.

More than a century later, close to 200 regulatory bodies across the world continue that mission. Each decision, dossier, and inspection contributes to a shared goal, global patient safety.

At DDReg, our experts work at the intersection of science and regulation, translating evolving global frameworks into actionable pathways for compliant, efficient market access.

Know more: https://tinyurl.com/msd2mh5w

26/10/2025

Canada’s regulatory framework rewards precision and preparation.

From clinical trial applications to market authorizations, each step demands alignment with Health Canada’s structured expectations.

DDReg builds regulatory strategies that anticipate these requirements, ensuring your Canadian submissions move with speed, accuracy, and foresight.

Know more: https://tinyurl.com/4nu3mydn

24/10/2025

Health Canada’s Notice of Compliance with Conditions (NOC/c) allows therapies with promising benefit–risk profiles to reach patients sooner, under the commitment of ongoing evidence generation.

It represents a strategic balance between innovation and accountability, enabling earlier access without compromising regulatory rigor.

Know more about Canadian Regulatory Framework: https://tinyurl.com/4nu3mydn

23/10/2025

Health Canada frequently enters the launch sequence before the EMA because of its predictable review timelines, structured guidance, and early adoption of ICH harmonization practices.

For global regulatory teams, this creates a strategic midpoint, a region that validates U.S. data while preparing for EU-level expectations.

Canada’s regulatory predictability has become an integral step in global go-to-market planning, not a regional afterthought.

Discover more: https://tinyurl.com/4nu3mydn

22/10/2025

𝐂 = 𝐂𝐚𝐧𝐚𝐝𝐚 | 𝐇𝐞𝐚𝐥𝐭𝐡 𝐂𝐚𝐧𝐚𝐝𝐚

Every regulatory authority has its own signature.
Health Canada’s is defined by consistency, transparency, and global trust, a model that has earned it credibility among regulators worldwide.

From drugs and devices to biologics, clinical trials, and pharmacovigilance, its framework stands out for predictable timelines and structured guidance, making Canada a reliable launch market for global pharma.

𝑭𝒐𝒖𝒏𝒅𝒆𝒅: 1919 | 𝑯𝑸: 𝑶𝒕𝒕𝒂𝒘𝒂

Link In Bio

21/10/2025

This Diwali, our DDReg family came together to celebrate the festival of lights, the values that guide us every day, clarity, collaboration, and commitment.

The celebration was filled with color, laughter, and a shared sense of purpose that truly reflects who we are as a team. From bright diyas and traditional attire to smiles that lit up the workplace.

Here’s to brighter beginnings, meaningful connections, and continued success for all.

Wishing everyone a prosperous and joyous Diwali from all of us at DDReg! 🌼✨

20/10/2025

As the diyas glow brighter, may your life be illuminated with happiness, harmony, and hope.

Wishing you and your loved ones joy, and prosperity that shine through the year ahead. ✨

19/10/2025

In global drug development, regulatory timelines are rarely linear.

Every authority interprets data differently, and those nuances shape review speed more than data quality itself.

The most successful teams don’t chase timelines; they govern them through predictive planning, inspection readiness, and adaptive sequencing.

Read full blog: https://tinyurl.com/cn382bhf

At DDReg, we help life sciences companies turn regulatory uncertainty into strategic foresight.

18/10/2025

Expanding into Brazil demands a deep understanding of ANVISA’s regulatory ecosystem.

From site inspections to pharmacovigilance readiness, every stage is designed to uphold quality, safety, and public health standards.

For global companies, aligning early with these expectations ensures smoother approvals and sustainable access.

DDReg’s regulatory experts bring a precise understanding of local frameworks and evolving ANVISA requirements to help you build compliant, enduring market strategies.

🔗 Discover how DDReg supports end-to-end regulatory pathways in Brazil: https://tinyurl.com/avben9r2

17/10/2025

Brazil isn’t a “follow-the-template” market, it’s a regulatory ecosystem of its own.

ANVISA’s approval pathway demands foresight, precision, and local fluency.
Success depends on mastering the details: GMP-first certification, CTD-based dossiers, and Portuguese submissions through local MAHs.

At DDReg, we help global pharma teams turn Brazil’s complexity into a competitive launch advantage.

Know more: https://tinyurl.com/avben9r2

16/10/2025

ANVISA’s regulatory model ties GMP certification directly to product approval.

For higher-risk drugs and medical devices, Brazil mandates a valid GMP/B-GMP certificate before registration.

ANVISA may inspect the site or rely on audit reports from recognized programs such as MDSAP or IMDRF.
Without proof of GMP compliance, even a complete dossier cannot advance.
In Brazil, audit readiness is regulatory readiness.

Discover more: https://tinyurl.com/avben9r2

Address

Units 444-451, Tower B2, 4-floor Spaze-I-Tech Park, Sector 49, Sohna Road
Gurugram
122018

Telephone

+911244361505-06

Website

https://www.ddregpharma.com/

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