In-depth analyses will highlight how pharmaceutical packaging, labeling, serialization, tracking, and traceability enhance consumer safety and transparency in the supply chain, as well as benefit pharmaceutical packaging that go beyond compliance with laws.
- July 18, 2022 Pharmaceuticals, Regulatory Artwork Services, Regulatory Labeling
- June 28, 2022 Regulatory Affairs, Regulatory Software & Services
Introducing innovative products across global marketplaces is imperative for life sciences companies to ensure profitability and maintain their presence in the market. Regulatory compliance and authorizations being the key factors behind any winning launch, inadequate Regulatory information can trigger an increase in costs and time-to-market.
- June 20, 2022 Pharmaceuticals, Regulatory Affairs, Publishing & Submissions, Market Access
Most life sciences organizations find it difficult to streamline their Regulatory submissions process due to frequent changes in the submission guidelines. According to a recent analysis conducted by the United States Food and Drug Administration (USFDA), 32% of submissions with study data had critical data conformance issues.
- June 20, 2022 Pharmaceuticals, Regulatory Affairs
The prime goal of a Health Authority (HA) is to promote and protect the interests of those it serves by amending and introducing new regulations. The European Medicines Regulatory Network (EMRN) is a network of competent authorities that work in sync to draft guidance documents that regulate medicines while upholding the standard of the medicinal products being authorized.
- June 17, 2022 Medical Devices, Regulatory Affairs
With the vision of global device traceability, South Korea’s Ministry of Food and Drug Safety (MFDS) has suggested/mandated? a new Regulatory requirement, for incorporating Unique Device Identification system (UDI) on medical devices. Medical device registration and UDI are integrated procedures, and UDI is a prerequisite for establishing medical devices in the Korean market.
- June 17, 2022 Pharmacovigilance, Pharmaceuticals, Regulatory Affairs
The journey of a drug product doesn’t end with its post-market authorization. The drug’s performance is now openly evaluated by the general population. To safeguard the population against any undesirable outcomes, post the consumption of a drug, a pharmacovigilance alert system is in place.
- June 15, 2022 Pharmaceuticals, Regulatory Affairs
Over the decades, advancements in treatment procedures have brought about necessary amendments to the Regulatory framework. From Active Pharmaceutical Ingredient (API) identification to its placement on the patient’s side table, the core of innovating novel treatment protocols revolves around three (03) fundamental characteristics, including safety, effectiveness, and timely availability to the patient population.
- June 14, 2022 Pharmaceuticals, Publishing & Submissions
Pharmaceutical companies incur about 25% of drug development costs into the documentation. Strategic imperatives can help accelerate the drug development pipeline along with scrutiny of clinical and Regulatory content, enabling efficient reuse of more standardized content. Identifying gaps associated with content authoring, review, and approval, describing set goals, and commencing a plan is a way to move forward.
- June 6, 2022 Medical Devices
The US is the largest medical device market, worth USD 180 billion (2021) and is expected to reach USD 670 billion at a CAGR of 5.2% from 2022 to 2027. The global medical device manufacturers find it promising to get their devices approved by US FDA and subsequently export them to the US.
- June 3, 2022 Pharmaceuticals, Publishing & Submissions
Over the past ten (10) years, the cost of bringing a drug into the market has increased by 140 percent. Globally, the top twenty (20) pharmaceutical organizations spend nearly sixty (60) billion dollars every year to bring a drug into the market and the average cost is estimated to be $2.6 billion, including drug failures.