Regulations Shop - Global Regulatory Partners, Inc.

USA
FDA Guidance: Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA
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USA
FDA Guidance: Data Integrity and Compliance With Drug CGMP Questions and Answers
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Brazil
GOOD MANUFACTURING PRACTICES FOR EXPERIMENTAL DRUGS USED IN CLINICAL TRIALS
$150.00 Add to cart
Brazil
GOOD MANUFACTURING PRACTICES OF MEDICAL DEVICES AND IN-VITRO DIAGNOSTIC PRODUCTS FOR IMPORTERS, DISTRIBUTORS, AND STORAGE COMPANIES
$10.00 Add to cart
Brazil
INSPECTION PROGRAMS AND ADMINISTRATIVE PROCEDURES TO GRANT OF GOOD MANUFACTURING PRACTICES CERTIFICATE TO MANUFACTURERS OF MEDICAL DEVICES LOCATED OUTSIDE THE BRAZILIAN TERRITORY AND MERCOSUR
$30.00 Add to cart
Brazil
Brazil’s Anvisa : Good Manufacturing Practice Certification for Medical Devices in Brazil
$30.00 Add to cart

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