Brova Inc.
West Covina, CA 91790, USA
Through an extensive network of strategic manufacturing partner worldwide we are able to offer the broadest range of innovative, high-quality, and sustainable ingredient solutions to the US pharmaceutical, nutritional, food, beverage and personal care industries.
By working closely with an extensive network of strategic manufacturing partners worldwide we are able to offer the broadest range of innovative, high-quality, and sustainable ingredient solutions to the US pharmaceutical, nutritional, food, beverage and personal care industries.
Our contracted third party testing laboratory works in compliance with the highest international quality standards and serves global leaders from both human and animal health industries with its testing, regulatory and CMO services. It has gradually obtained the highest level of accreditation and certification from both international and domestic authorities by continuously improving its quality management system and testing capabilities.
It was inspected and approved by the U.S. FDA in Jul. 2013 and re-inspected in Jun. 2016 with Zero 483 issued. Serving as a dedicated QC center with the world highest qualification, we are offering the global pharmaceutical industry FDA standard QC testing & release control, on-site QA back-up, API & formulation R&D, regulatory support, supply chain and risk management. As an ISO9001-certified CRO company, we welcome API sourcing, contract testing, R&D, and toll manufacture opportunity of APIs and formulations.
Third-party testing services will greatly promote the elimination of non-tariff technical trade barriers, reduce duplication of detections, and enhance the access of the products to overseas markets.
Our international regulatory team can provide the customers with supplier quality management services to achieve a high standard of industry. We offer global, customized, managed drug / food supplier audit, supplier remediation, official certification and registration services. Meanwhile, we have assisted many companies nationwide to improve their quality management system. We are proud of helping the companies to achieve a number of successful FDA/EU approvals and customer audits.
Regulatory team can provide:
Third Party Audit and Certification Services:
a) cGMP/EHS audit: customized supplier audit, CAPA establishment and tracking, GMP improvement.
b) FDA/EDQM/EU GMP/ other market certification services: GMP gap analysis, mock audit, technical support of site inspection.
c) FDA Warning Letter and Import Alert relieving.
d) Oral and written English Translation services for FDA/EDQM inspection and customer audit.
Regulatory Services:
a) DMF/VMF/CEP/ASMF filing: compiling and review, eCTD/eSubmitter conversion and ESG/CESP submission, deficiency letter response.
b) U.S. FDA electronic registration: Drug/Medical device/Food facility Establishment Registration and Listing.
c) U.S. agent service.
d) Customized regulatory services for other countries.