DDReg pharma

Quailty Driven by Passion

Submit Query

All Category

Home » All Category » Page 18

Essential Aspects of Labeling for Clinical Supplies and Investigational Products

All Category, Blogs /

With the expansion of clinical research and development, precise labeling of investigational products is not merely a formality but a critical aspect ensuring the safety, efficacy, and regulatory compliance of clinical trials. Pharmaceutical companies are obliged to follow an integrated approach in labeling considering all aspects of clinical study planning to promote multilingual and multicultural […]

Essential Aspects of Labeling for Clinical Supplies and Investigational Products Read More »

data requirements for ANADA filings case study

Fulfilling stability data requirements for ANADA filings

All Category, Case Studies, Regulatory /

Customer Requirement: An animal product company, based in Ireland, wanted to file an abbreviated new animal drug application (ANADA) with the United States Food and Drug administration (US FDA) for its non-steroidal anti-inflammatory drug (NSAID) product. The drug is used to relieve pain and inflammation that is associated with osteoarthritis & control post-operative pain in

Fulfilling stability data requirements for ANADA filings Read More »

Asserting Patient Rights: The Importance of Labels for Medical Device Traceability

All Category, Blogs, Pharmacovigilance /

In the realm of healthcare, patients have a fundamental right to transparency and information regarding the procedures they undergo particularly with respect to medical devices used for surgical procedures. One often overlooks the aspect of this right which is the traceability labels for medical devices used in surgical procedures regardless of whether the device is

Asserting Patient Rights: The Importance of Labels for Medical Device Traceability Read More »

Importance of Collaboration between Global Regulators

All Category, 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 »

DDReg Opens German Entity in Cologne (Köln)

All Category, News and Events /

DDReg is thrilled to announce a significant milestone that is the establishment of its new entity in Cologne (Köln), Germany. This strategic development marks a pivotal moment for DDReg in expanding & enhancing its global presence and reflects DDReg’s commitment to better serve its customers in their requirements for/in the European market. DDReg is confident

DDReg Opens German Entity in Cologne (Köln) Read More »

Submitting Revised ANDA Labels to Ensure Safety & Compliance

All Category, Blogs /

Regulatory scrutiny for abbreviated new drug applications (ANDAs) places a strong focus on the accuracy and completeness of ANDA labels. Not only does this provide comprehensive information to healthcare professionals, but it also communicates information on medication usage and potential risks to ensure patients get clear and detailed information. This meticulous review process highlights the

Submitting Revised ANDA Labels to Ensure Safety & Compliance Read More »

Development of CAR T Cell Products

All Category, Blogs /

Chimeric antigen receptor (CAR) T cell products refer to therapeutic human gene therapy products. They involve the genetic modification of T cell specificity which allows them to recognize a specific target antigen for therapeutic use.  CAR T cells are associated with many challenges related to their development, manufacturing, testing, and even clinical evaluation. Therefore, it

Development of CAR T Cell Products Read More »

Model-Integrated Evidence Program for Generic Drugs

All Category, Blogs /

Timely patient access to affordable treatment options is the goal of healthcare and regulatory agencies worldwide. To support this, early and frequent communication between drug applicants and regulatory agencies is required to expedite generic drug development and approval. Streamlined communication allows a better and clearer understanding of regulatory expectations and facilitates a more efficient application

Model-Integrated Evidence Program for Generic Drugs Read More »

Searchable Databases for Bio-Equivalence Guidance

All Category, Blogs, Medical Writing /

Product-specific bioequivalence guidelines are crucial to support the development of safe, efficacious, and high-quality generic products. They provide information to manufacturers on how they can demonstrate therapeutic equivalence of their products compared to the reference drugs. Adherence to these guidelines streamline the regulatory approval process while also ensuring confidence with respect to the interchangeability of

Searchable Databases for Bio-Equivalence Guidance Read More »