DMF Submissions | Dossier Submissions | DUNS Number| Establishment registration |Trainings | GAP Analysis |Risk Management|Vendor Qualification| CSV
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Costarica pharmaceuticals support all regulatory documentation DUNS registration, maintenance, Establishing web trader account, Drug establishment registration, Obtaining FEI number Obtaining Labeler code, Submitting NDC number, Self identification of facilities, Generating cover sheet for fee payment, Generating cover sheet for fee payment, Food facility registration, Blanket no change notification updating address changes if any
Costarica pharmaceuticals support submitting DMF to US FDA, EU countries, Health Canada, TGA and other regulatory bodies, Submitting VMF to USFDA using eSubmitter tool, Responding to the queries received from the agencies in a timely manner, Submitting CEP to EDQM, Responding to the queries received from EDQM and getting CEP approval in timely manner
Costarica pharmaceuticals also involved Evaluation of process for any possible geotaxis impurities and setting limits for the same as per the applicable guidelines, Setting specification limit for impurities, Providing guidance throughout life cycle of the product, Guiding on all regulatory issues faced during day to day activities (from customer or agency).
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Costarica pharmaceuticals support all regulatory documentation DUNS registration, maintenance, Establishing web trader account, Drug establishment registration, Obtaining FEI number Obtaining Labeler code, Submitting NDC number, Self identification of facilities, Generating cover sheet for fee payment, Generating cover sheet for fee payment, Food facility registration, Blanket no change notification updating address changes if any
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Costarica pharmaceuticals support all regulatory documentation DUNS registration, maintenance, Establishing web trader account, Drug establishment registration, Obtaining FEI number Obtaining Labeler code, Submitting NDC number, Self identification of facilities, Generating cover sheet for fee payment, Generating cover sheet for fee payment, Food facility registration, Blanket no change notification updating address changes if any
Costarica pharmaceuticals support submitting DMF to US FDA, EU countries, Health Canada, TGA and other regulatory bodies, Submitting VMF to USFDA using eSubmitter tool, Responding to the queries received from the agencies in a timely manner, Submitting CEP to EDQM, Responding to the queries received from EDQM and getting CEP approval in timely manner
Costarica pharmaceuticals also involved Evaluation of process for any possible geotaxis impurities and setting limits for the same as per the applicable guidelines, Setting specification limit for impurities, Providing guidance throughout life cycle of the product, Guiding on all regulatory issues faced during day to day activities (from customer or agency).
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Costarica is a dynamic , rapidly evolving organization working to meet the needs of the Pharmaceutical and Health care industry as well as professionals and their patients To ensure we can continue to deliver on our commitments to the customers who rely on us, we are focused on improving the way we do business; on operating with transparency in everything we do, and on listening to the views of all of the people involved in health care decisions. our goal is to ensure that people everywhere have access to innovative treatments and quality health care.
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