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Advent Pharmaceuticals, Inc. (AP) also provides Regulatory Compliance services to industries regulated by the United States Food and Drug Administration (FDA), the Chinese State Food and Drug Administration (SFDA) and similar agencies world-wide. Services provided include the evaluation of Good Manufacturing Practice (cGMP), Good Clinical Practices (cGCP) and Good Laboratory Practices (cGLP), regulatory filings, the planning clinical studies. AP has very broad experience with generic and proprietary drugs, biologics, vaccines and medical devices. AP provides pharmaceutical consulting services and compliance (cGXP) training to companies world-wide for:
▪ Drugs, Biologics, Vaccines and Devices
▪ Clinical Studies
▪ Manufacturing Scale – Up
▪ Commercial Manufacturing
▪ cGMP, cGCP and cGLP Expertise
▪ Compliance Training
▪ Regulatory Filings
Preparation of Regulatory Filings and Submissions
AP, Inc. has successfully prepared numerous regulatory submissions for approval with the Chinese FDA (SFDA) and we have expertise in preparing and filing New Drug Applications (NDA), Abbreviated New Drug Applications (ANDA), Investigational New Drug Applications (IND), Premarket Notifications (510(k)), Devices, Biologics License Applications (BLA), Premarket Approval Applications (PMA), Drug Master Files and Device Master Files (DMF).
AP, Inc. provides guidance and assistance in compliance with government regulations for all aspects of the pharmaceutical products (Generic and Brand) and medical devices. AP, Inc. constantly monitors regulations of the United States and other countries in order to provide the best assistance in commercializing and bringing to market prescription drugs, biologics, medical devices, and over-the-counter products. AP, Inc. offers the advantage to companies wishing to take their products to the Chinese market by having offices in the U.S.A. and China.
Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), and Good Laboratory Practice (GLP) Evaluation
AP, Inc. has extensive experience in successfully preparing sites for United States Food and Drug Administration (FDA) approval for Pre-approval inspections (PAIs), clinical material preparation, commercial manufacturing, testing, validation, packaging and labeling operations. AP, Inc. can provide expertise in equipment; solid and liquid dosage forms; parenterals; purified water; sterility assurance; support systems; and utilities.
Advent Pharmaceuticals can also provide expertise to:
- Evaluate compliance with the FDA and other regulatory agency standards.
- Perform cGXP (cGMP, cGCP, cGLP) audits.
- Prepare standard operating procedures (SOP) for Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), and Good Laboratory Practice (GLP)
- Provide expertise in building commercial and pilot plant facilities.
- Provide vendor certification.
- Conduct training in cGXP (cGMP, cGCP and cGLP)
- Assist with clinical studies in China in compliance with applicable regulations.
- Assist in the preparation of responses to FDA Form 483 observations and warning letters.
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Liaise with the United States FDA, the Chinese FDA (SFDA) and other regulatory agencies.
Contact us for more details at (800)331-9293 | 
