A small Spanish medical device company wanted to initiate their first medical device investigation in France and Spain. However, the company was unaware of the medical device clinical investigational requirements.
Being a European Commission-funded project, this project is crucial for the Client and RegPak. After successful completion of this program, the company intends that RegPak continues to support other studies too including CE marking of the current device for marketing in the future.
A major pharmaceutical company, based in Europe, faced a challenge in seeking approval of medicinal product containing controlled DS.
RegPak BioPharma prepared the dossier for the Agency dealing with Controlled Drugs to seek approval prior to gaining regulatory approval.
The work was delivered within a short time to the client, following which the responsibility of MAA submission was given to RegPak BioPharma.
Founder of RegPak BioPharma, Parminder Kaur, was responsible for International RA functional set-up at Janssen Biologics, Leiden.
For this effort, Parminder Kaur had been awarded the highest “Platinum Award” by JnJ.
RegPak BioPharma has assisted many clients since then for in-house establishment of regulatory /PV function.
A major pharmaceutical company, based in India, faced a challenge in review and update of a Module 3 and Quality Overall Summary for a Biosimilar product (mAb) in preparation for a European submission. The product was going to be manufactured in China, thus GMP compliance was another issue to be looked into.
The product was planned to be submitted via the Centralised procedure according to stringent Company deadlines, prior to which a pre-submission meeting was planned with the EMA.
RegPak consultant reviewed and updated the submission documents and provided a corrective action list for the manufacturing site. The client reviewed the Site Master File and suggested the pre-submission activities to be performed.
The work was delivered within 1 month to the client, following which the company decided to postpone the submission so as to fulfill the gaps analyzed.
A well-known company based in Germany and Switzerland required immediate assistance with a global update to the labeling due to new manufacturing sites and changes to core safety information.
RegPak consultant with experience in global labeling compliance and CCDS took over this project. The project was staggered by market factors such as the number of language requirements for any one region or market.
As with most projects of this kind, other issues were identified e.g., outdated package inserts being used, labels having outdated excipients listed, etc.
A well-known company based in Germany and Switzerland required immediate assistance with a global update to the labeling due to new manufacturing sites and changes to core safety information.
RegPak consultant with experience in global labeling compliance and CCDS took over this project. The project was staggered by market factors such as the number of language requirements for any one region or market.
As with most projects of this kind, other issues were identified e.g., outdated package inserts being used, labels having outdated excipients listed, etc.
