PHarmaceuticals - Case Studies
Latin America Establishment & New Drug Submission
QUICK FACTSCLIENT Large International Pharmaceutical Manufacturer SERVICES SUPPLIED
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OBJECTIVE
Assist in a large international pharmaceutical company in obtaining local offices as well as successful meetings with COFEPRIS in Mexico and ANVISA in Brazil. Reformat all dossiers to local requirements and submit for approval. SOLUTION DETAILS The client was moving into the Latin American region for the first time. They desired to start in Mexico, with submissions shortly after in Brazil. RJR Assisted with identifying potential offices as well as local warehouses, testing laboratories and distributor requirements. We ensured that all necessary local and federal licenses were received for acceptance of new drug submissions. RJR worked with the client to schedule pre-submission meetings with the agencies of COFEPRIS and ANVISA. RJR local regulatory experts assisted in setting up these meeting, as well as attending them and providing local insight in to what should be presented and accomplished in these meetings. PowerPoint templates were made to assist in the information to be presented to the agencies, as well as questions desired to be answered. RJR also assisted with reviewing the current CTD dossiers, and reformatting these dossiers in to the individual country requirements for Mexico and Brazil. When reformatting, RJR also used their insight to reduce intellectual property concern in certain sections, by reducing data, using our knowledge and expertise for successful and compliant submissions. All documents were then translated and bound according to the individual country requirements RJR assisted with submitting the dossiers as well as follow up for approval. The client was one fate first companies to get their products approved under the new law and structure of COFEPRIS in 2010, with review and approval times of just one year. OUTCOME By having weekly teleconferences, RJR met all goals and timelines of the client, as set early in the process. All company licenses were successfully approved prior to submissions and all dossiers were successfully accepted and approved in both countries, within average or shorter than normal review times |
Latin America Surveillance & Company Expansion
Quick FActsCLIENT Large International Pharmaceutical Manufacturer SERVICE SUPPLIED
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OBJECTIVE
Assist a large international pharmaceutical company in obtaining information on local laws and requirements SOLUTION DETAILS The client was looking to expand their presence in the Latin American region. They desired to know the requirements for filing submissions for generic products in Argentina, Mexico, Brazil, Colombia, Peru, Venezuela, and Chile. RJR outlined the requirements, as well as timeframes it would take, to obtain all necessary licenses based on how they desired to be set up on each country. RJR outlined potential office requirements, as well as local warehouse, testing and distributor requirements. RJR wrote up a report for the client based on specific questions and information that they desired to know. We provided the clear definitions of the different local pharmaceutical terms per country, in addition to the requirements to market their product, based on how it would be defined in each country. With the write up of the country requirements, a copy of the actual laws were also provided. We provided the testing requirements needed, as well as a registered reference product and that product's status in each country (i.e. name, MAH, route, form, dose, date approved, exclusivity dat, etc.) from the local government agencies. Additionally provided in the report, were the packaging and labeling requirements, and zone stability data for their product, based on each country's regulations. OUTCOME The client was very please with the quality of information provided and was able to decide on the next steps of the expansion of their company, based on many different factors, including licenses needed, timing and when the reference product would be out of exclusivity. Because of the information provided by RJR, the client was able to get a clear view of which countries would be in their best interest to expand to next. |
European MRP Submissions
QUICK FACTSCLIENT International Radioactive Pharmaceutical Manufacturer SERVICES SUPPLIED
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QUICK FACTSCLIENT International Radioactive Pharmaceutical Manufacturer SERVICES SUPPLIED
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OBJECTIVE
Assist an international radioactive pharmaceutical company in reformatting an old MHRA dossier to CTD formatting and submit MRP in separate waves of countries for approval. Also assist in maintaining the authorizations through compiling and submitting variations and renewals as needed. SOLUTION DETAILS The client desired to broaden their scope of countries beyond the RMS (UK) for their product. RJR assisted with the reformatting of the old MHRA application, with CTD formatting for the MRP submission. The MRP submission was made in two waves to obtain additional country licenses. RJR was the main contract with MHRA and worked with the reviewer at MHRA, to provide any additional requested documentation by the different concerned member states. RJR's local European office worked with the different concerned member state, particularly in Spain and France, to assist with labeling desires and local requirements. We also were able to set up a pharmacovigilance plan quickly when requested during review, after a new regulation was put in place. We have continued to assist the client with renewals and multiple variations throughout the years, always complying with the local and MRP requirements that are ever changing. OUTCOME RJR has met all goals and timelines of the client through the years as brach of the client's regulatory team. Together we have achieved 100% approval of all submissions. |
Over-The-Counter (OTC) Drug Compliance
QUICK FactsCLIENT Marketer of OTC Drug Products SERVICES SUPPLIED
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QUICK FactsCLIENT Marketer of OTC Drug Products SERVICES SUPPLIED
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OBJECTIVE
Assist a small Private Label Distributor of OTC drugs to assess their portfolio of products for regulatory compliance against the appropriate FDA OTC drug monographs. Identify and help implement necessary labeling and advertising changes and provide continued regulatory feedback to ensure the company remains in compliance. Assist client with the required FDA drug listings for their product portfolio and provide insight on specific questions regarding GMP compliance. SOLUTION DETAILS Following a management change, the client requested that RJR assess their portfolio of products for compliance against the US FDA OTC drug monographs. During the assessment, RJR identified a number of areas in the labeling and advertising that required modification to come into compliance with the applicable monographs. RJR worked with client to implement suggested labeling changes. We performed a regulatory review of all marketing content against FDA and FTC advertising guidelines and assisted new management in implementing key modifications to their web site to remove any undesirable risks. We also provided feedback on specific GMP compliance questions and completed product listings for each new product through CDER Direct. OUTCOME Product portfolio is compliant with FDA OTC drug monographs, labeling and drug listing requirements. The marketing approach was revised to remove undesirable risks and the client continues to leverage RJR to review and provide proactive feedback on new products prior to marketing. |