DDReg Pharma

DELIVER BETTER DATA TO ENSURE FASTER APPROVAL
DDReg Pharma

Regulatory

Drug-device registration in CIS countries

Customer Requirement: A global Non-profit organization in the area of female health & wellness wanted to obtain drug device registration and market authorization for their contraceptive that included its administration device, in CIS region, including Azerbaijan, Kyrgyzstan and Tajikistan.  The contraceptive was classified as a drug-device combination product for which regulations are challenging to navigate …

Drug-device registration in CIS countries Read More »

Accelerating access to Women’s Health products

Customer Requirement: Women’s health and fertility are vital aspects of their overall well-being, and yet they often remain shrouded in silence and misconception. Every woman has the right to access healthcare, irrespective of their socioeconomic background or geographical location, though many women face significant challenges and barriers that restricts their access to the medications they …

Accelerating access to Women’s Health products Read More »

Web-based Lifecycle Management Tool

Customer Requirement: A Non-profit organization faced challenges in tracking and monitoring the registration status of their products in respective regions. This is because they had one product  in multiple markets that were each in different stages of their lifecycle. Siloed and disconnected tracking systems meant that the organization was left with little insight into the …

Web-based Lifecycle Management Tool Read More »

Maintaining Compliance

Maintaining compliance with Identification of Medicinal Products (IDMP) standards

The pharmaceutical industry including its operations and associated functions run on data and content. Whether it is safety, regulatory, or clinical data, the pharmaceutical industry and all its stakeholders are actively involved in collecting, monitoring, evaluating, and exchanging crucial information. Indeed, the need for standardization of medicinal product information was highlighted in order to facilitate …

Maintaining compliance with Identification of Medicinal Products (IDMP) standards Read More »

Combination Products

Combination products: a regulatory perspective

Combination products are an integral part of healthcare as they provide innovative treatment options for complex diseases. They can be as simple as a first aid kit with vials & syringes or as complex as antibody-drug conjugates combined with drugs [1]. More often the development of combination products helps to enhance the function of an …

Combination products: a regulatory perspective Read More »

Combination Products

Pre-market pathways for combination products

The regulatory landscape for combination products has been somewhat of a “question-mark” for manufacturers for various reasons. This is because when drugs, devices, and/or biologics get combined to produce a combination product, there is uncertainty on which regulatory requirements will apply to the components of the product and the product as a whole. Furthermore, the …

Pre-market pathways for combination products Read More »

Orphan Drugs in Hereditary Angioedema

Access to Orphan Drugs in Hereditary Angioedema

IntroductionHereditary angioedema (HAE) is considered a rare, autosomal dominant disease that is characterized by repeated episodes of swelling which can occur on the face, limbs and even the gastrointestinal and respiratory tracts leading to severe pain, vomiting, and asphyxiation. These swelling attacks may occur unexpectedly and can significantly affect a patient’s quality of life (QoL). …

Access to Orphan Drugs in Hereditary Angioedema Read More »