As one of the leading pharmaceutical Regulatory consulting firms, DDReg is involved in a wide variety of pharma regulatory assignments from organizations across the globe for regulated and emerging markets. Today, we are honored to announce to you that DDReg has taken the next big step and opened its new entity DDReg Pharma Inc. in Wilmington, […]
DDReg opens entity in the USA Read More »
In 2019, the African Union’s Bureau of Heads of State and Government approved a new Treaty for the establishment of the African Medicines Agency (AMA) to improve countries’ ability to regulate medical products. It appeared like AMA will become a reality now that 15 African Union Member States have ratified the Treaty in recent months.
All About African Medicines Agency Read More »
Integral health integrates traditional treatment in a coordinated way with alternative medicine. Multimodal interventions, which combine two or more interventions such as conventional medicine, lifestyle changes, physical rehabilitation, psychotherapy and complementary health approaches in various combinations, with an emphasis on treating the whole person rather than, for example, one organ system, are also emphasized in
What is Role of Integrative Medicine in Healthcare? Read More »
Knowledge Management Regulatory Affairs (KMRA) has been a recognized discipline in other sectors for over 20 years, but it has taken a long time for the biopharmaceutical business to debate and formalize it. When the ICH guideline paper Pharmaceutical Quality System: Q10 was published in 2008, it highlighted knowledge management as a major enabler of
Knowledge Management in Regulatory Affairs (KMRA) Read More »
The COVID-19 pandemic has forced healthcare systems to drastically and quickly rethink how they offer care. The unusually rapid spread of telehealth has been one of the most astonishing continuing trends. The pandemic may offer the impetus required to fulfill telehealth’s full potential. Nonetheless, there are fears that fast deregulation might jeopardize safety and privacy, despite
Telehealth – Regulatory Perspective Read More »
With a laser-like emphasis on results and value, healthcare is fast moving to a new world of patient choice. Indeed, healthcare systems that have historically emphasized medical treatments based on episodic interactions with patients are now realizing the need to fully comprehend external variables and provide ongoing care. Exogenous factors like genomics, conduct and social
Expanded use of RWE (Real World Evidence) Read More »
One of the fastest-expanding technologies on the planet at present is Artificial Intelligence (AI) in the pharma Industry. It has been gaining so much popularity lately that even industries and sectors have applications and use cases for it. Even from smart factories using AI to ramp up their production efforts, to the smart assistant in
Artificial Intelligence – Impact on The Global Pharma Industry Read More »
IDMP is a progression of five specific guidelines established by the International Organization for Standardization (ISO) that emphasize different identification standards in the pharma industry. These standards establish an internationally recognized framework for uniquely identifying and describing pharmaceutical items, as well as for standardized documentation, coding and product information interchange across global regulators, manufacturers, suppliers
Identification of Medicinal Products (IDMP) – The Perspective of US FDA & EMA Read More »
A UK based company with manufacturing locations around the globe and a large consumer healthcare portfolio required in-market compliance check for its products all across the globe. The brands were very popular and could not afford to go off the shelf due to non-compliance should an agency inspection happen. DDReg was tasked to carry out
Worldwide In-Market compliance Read More »
Manufacturer of a very popular Menstrual Pain Patch with herbal ingredients wanted to introduce the product in USA. The product had herbal constituents sourced from India. With very strict US FDA requirements for importing and selling medicinal products in USA, the company wanted to have the right regulatory strategy, as the business opportunity was big.
Introduction of Indian Herbal Pain Patch in the USA Read More »
