DDReg pharma

Quailty Driven by Passion

Submit Query

Regulatory

Home » Insights » Regulatory
Regulatory Support for Cosmetics Products in Latin America

Regulatory Standards for Cosmetics in Latin America 

Insights, Regulatory /

Latin America (LATAM) is one of the fastest-growing regions for cosmetics, with annual growth rates often surpassing global averages. Among its key markets, Brazil stands out as the largest, followed closely by Mexico, Argentina, Colombia, and others. However, for companies aiming to manufacture or export cosmetic products to LATAM, understanding the region’s fragmented regulatory processes […]

Regulatory Standards for Cosmetics in Latin America  Read More »

EU & USA Post-Market Surveillance (PMS) plans for medical devices

Post-Market Surveillance (PMS) in Medical Devices : USA & EU

Insights, Pharmacovigilance, Regulatory /

As a regulatory leader, your responsibility doesn’t end with market approval, it begins there. This sentiment echoes across boardrooms and regulatory strategy meetings as post-market surveillance (PMS) becomes a critical pillar of lifecycle management in medical devices. In the times where real-world performance, patient safety, and global compliance are under the spotlight, PMS is a

Post-Market Surveillance (PMS) in Medical Devices : USA & EU Read More »

Environmental Risk Assessment in Pharmaceutical Development

The Role of Environmental Risk Assessment in Sustainable Pharmaceutical Development 

Insights, Pharmacovigilance, Regulatory /

When a new drug is developed, its environmental journey does not end at the pharmacy shelf. Active pharmaceutical ingredients (APIs) can enter water bodies and soils through manufacturing discharges, patient excretion, or improper disposal. If not addressed, these residues may disrupt ecosystems and pose long-term environmental risks.  Environmental Risk Assessment (ERA) has thus become an

The Role of Environmental Risk Assessment in Sustainable Pharmaceutical Development  Read More »

Regulatory Compliance Pathway in the Middle East

Insights into the Pharmaceutical Regulatory Framework of the Middle East

Insights, Regulatory /

Middle Eastern pharmaceutical companies are increasingly prioritizing innovation, amid significant regulatory reforms and harmonization efforts. The region encompassing a diverse range of countries, presents both challenges and opportunities for companies aiming to enter these markets. In this Blog, we explore the key elements of the evolving regulatory frameworks in middle east. Fragmented and complex regulatory

Insights into the Pharmaceutical Regulatory Framework of the Middle East Read More »

Managing pharma regulatory risks with big data

A Strategic Approach for Managing Pharma Regulatory Risks with Big Data

Insights, Regulatory /

The pharmaceutical industry’s journey into the digital age has been accelerated by the integration of big data (BD) and artificial intelligence (AI). With vast datasets from research, clinical trials, and manufacturing processes, big data provides pharmaceutical firms an unparalleled opportunity to refine processes, enhance patient outcomes, and ensure compliance with increasingly stringent regulatory requirements. However,

A Strategic Approach for Managing Pharma Regulatory Risks with Big Data Read More »

Guidance Nonclinical Development of Oligonucleotide

FDA’s First Draft Guidance on Nonclinical Development of Oligonucleotides

Insights, Regulatory /

The rapid evolution of biotechnology has positioned oligonucleotide-based therapeutics as one of the most promising therapeutic innovations in medicine today. From antisense oligonucleotides (ASOs) to small interfering RNAs (siRNAs) mRNA, and guide RNAs (gRNAs), these molecules are reshaping how we approach previously untreatable conditions. Recognizing the potential and complexity of this expanding area, and the

FDA’s First Draft Guidance on Nonclinical Development of Oligonucleotides Read More »

EMA's expedited pathways

How EMA’s Expedited Pathways and Scientific Advice Are Shaping Drug Approvals

Insights, Regulatory /

At the DIA 2024 Global Annual Meeting in San Diego, key officials from the European Medicines Agency (EMA) shed light on the various expedited approval pathways available for sponsors of innovative drugs and Advanced Therapy Medicinal Products (ATMPs). This blog post explores the insights shared by EMA officials, delves into the various expedited pathways available,

How EMA’s Expedited Pathways and Scientific Advice Are Shaping Drug Approvals Read More »

Safety Testing of Allogeneic Cells used in Cell Based Medical Products

Insights, Medical Writing, Pharmacovigilance, Regulatory /

Cell based medicinal products use a single source of cells to treat multiple patients. For example, allogeneic cell therapies use donor cells to create a Master Cell Bank (MCB) that are then processed to be used in different kinds of therapies. The use of allogeneic cells to develop medicinal products and therapies demands rigorous testing

Safety Testing of Allogeneic Cells used in Cell Based Medical Products Read More »

Redesigned Pre-Submission Meetings for ANDAs with the US FDA

Insights, Regulatory /

Pre ANDA meetings facilitate pre-submission communications with the US FDA to discuss questions related to complex products and/or complicated drug development questions. These were introduced in GDUFA II. In the GDUFA III some pre submission meetings have been redesigned to support prospective applicants in obtaining feedback from the Agency regarding their complex generics or complicated

Redesigned Pre-Submission Meetings for ANDAs with the US FDA Read More »

Importance of Collaboration between Global Regulators

Insights, Regulatory /

Regulatory authorities across the globe play a pivotal role in safeguarding patient safety and ensure regulatory compliance. Each authority functions in its unique way to uphold standards and ultimately ensure the well-being of individuals. In the UK, the MHRA shoulders the vital responsibility of ensuring that medicines, medical devices, blood components for transfusion are safe, of

Importance of Collaboration between Global Regulators Read More »