A very large company based in Mumbai had to prepare Module 2, 4 & 5 for a biological product for exports. Although the company had well qualified and experienced staff for the same, it was decided to outsource the services through us for technical expertise and timely registeration.
We performed world wide search for relevant articles on Module 4 and 5. The due consideration was also given to the in house Non Clinical and Clinical trials conducted by the customer. The most suitable and relevant articles were identified by our experts. The same were duly summarized in our own words for Module 2. The entire presentation was discussed with technical personnel of the company. The final version was duly accepted by the customer and regulatory authorities.
Many large companies having world Class facilities for Hard Gelatin capsule manufacturing in India were in urgent need for US DMF Type III to meet urgent requirement from Overseas Customer.
We performed cGMP audit to find out the real gaps in design and functioning of the unit. The solution to all the deficiencies was provided and the staff was trained to accomplish the task. A US DMF Type III was filed with US FDA .The company name was listed on US FDA site.
We were asked to convert normative document into eCTD by a Pharmaceutical Unit in India
The presentation was thoroughly studied by team members of PPC. The missing information was identified and fulfilled. The leaf files for each product attribute were re-defined as per ICH Guidelines. Finally the entire data was fitted into eCTD frame and was submitted to FDA.
We were asked to strengthened the regulatory compliance for the products exported by the company
Initially cGMP system of the company was strengthened through gap analysis. Further US and Canadian DMF was filed .Thereafter, eCTD was developed and filed with various regulators.
We were asked to provide Support for labeling of foreign cosmetic products for marketing in India.
We duly studied the Laws concerning manufacturing and marketing of Cosmetics in India. We suggested about the changes in the label which shall be incorporated for marketing Authorization in India.
We were consulted for licensing requirements for certain product for export to India
We were consulted for Plant Layout for new facilities.
This was very common assignment from many customers. The manufacturing plan and space available for construction were suitably matched to evolve a plant layout to suit for smooth production and regulatory approvals.
We were consulted to resolve FDA 483 Notifications.
The notifications were studied in detail and solution was provided for each and every query.
A Pharmaceutical Company in India had a failing sales as compared to their competitors who were commanding the business easily.
All the concerned Pharmaceutical Companies were assessed for their reputation and technical capabilities. It was revealed that most of the leading companies had US DMF and CEP for their products. Following this, we decided to implement cGMP Training and file US DMF and CEP With current GMP in view a gap analysis was performed and forward implementation plan was suggested to the company. At the same time the company was prompted to file US DMF and CEP
The result of the project was a vastly improved sales enquiries and actual orders.
A company in South America was licensed to manufacture novel veterinary drugs. The company had world class manufacturing facilities and animal house for testing the e products. However, the products were not readily accepted by many countries in Europe. We were asked to provide technical and regulatory support for the same.
We studied the product thoroughly. There were no technical issues with the product. However, the information on safety and efficacy was almost negligible. We drafted the dossier as per European Guidelines. The same were accepted and the company was pleasantly surprised to see her business growing many folds.
The company in India was licensed to manufacture anticancer drugs. The company had developed world class facilities for manufacturing the same as per WHO and EU guidelines.
A sales deed was materialized in advance. However, the final order were withheld for non availability of dossiers
We visited the company in Mumbai. The available documents were collected from QC/QA heads for compilation into dossiers. The missing analytical tests were performed at contract laboratories and the updated dossiers were submitted to the party. The same were readily approved by the buyer and the company was rewarded with long standing orders.
