Regulatory Strategies / Expert Views
Regulations pertaining to pharmaceutical products are continuously changing...
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Regulatory Certification of Pharmaceutical Products
Administrative documents are an integral component of regulatory submissions and constitute key certifications. These can include Letter of Authorization (LOA) Certificate of Pharmaceutical Product (CPP), Certificate of Suitability (CEP), Good Manufacturing Practice (GMP) etc. Regulatory services agencies require manufacturers to have these certificates notarized, apostille, and legalized if they wish to enter a new market which guarantees the authenticity and ultimately the quality of the product to expedite market access.
Legalization practices vary across different regions; certain agencies may require document submission to be done online while others require in-person submission. Similarly, depending on the country, a certificate need not be legalized if it has been notarized and apostille. Navigating through such requirements for certificate verification can be challenging for manufacturers that wish to penetrate an unfamiliar market or region.
DDReg has experience in vast majority of developed and emerging markets that require administrative certification to be notarized, apostilled, and legalized for timely submissions. DDReg’s local representatives liaise with the appropriate Embassy and Chamber of Commerce to get administrative certificates notarized, apostilled, and legalized for timely submission of dossiers. Whether they are regional differences in certificate requirements, translation services, or physical certificate submission, DDReg covers all aspects of verifying administrative certificates.
Our Regulatory Affairs Consulting Services portfolio covers:
New Product Authorizations
Pharmaceuticals and other medicinal products need to be prior authorized by...
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Gap Analysis and Remediation
A gap analysis is a regulatory review process that identifies data gaps in the technical...
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Regulatory Due Diligence
Regulatory issues arise unexpectedly and can create significant strain on a company’s...
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DDReg provides expert consulting and efficient services for quality Drug Substance...
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CMC Advisory
When it comes to regulatory strategies, CMC documentation play a crucial role in developing...
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Post Approval Life Cycle Management
Managing the post-approval life cycle of a product is an essential component to sustaining...
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Regulatory Certification
Administrative documents are an integral component of regulatory submissions and constitute key certifications...
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ANDA and MA Holder Services
The regulatory approval pathway for Abbreviated New Drug Applications (ANDAs) is relatively complex....
Read More ➔Basics of notarization, apostille, and legalization.
Notarization, apostille, and legalization are processes through which administrative documents and certificates are authenticated in order to support regulatory submissions. They differ in scope and purpose, so it is critical to understand the distinctions in order to support the international acceptance of critical documents. Different regulatory authorities may have different requirements with respect to notarization, apostille, and legalization of respective documents & certificates. Harmonizing these processes facilitates the smooth submission and acceptance of regulatory documents. Notarization of certificates is common for national documents but may not be sufficient for international use; apostille of a certificate or document simplifies its acceptance across Member countries reducing the need for further legalization. Legalization of certificates and documents involves the authentication by multiple authorities and is necessary for those countries not recognizing the apostille.
Basics of administrative documents and certificates services for regulatory
Certificate of pharmaceutical product: This is a document issued by regulatory authorities which confirms the safety, efficacy, and quality of a pharmaceutical product. It facilitates international trade and ensures regulatory compliance to expedite the product approval process.
Letter of Authorization: This document grants permission to an entity or individual to act on behalf of another in regulatory matters. A Letter of Authorization is pivotal in delegating responsibilities, facilitating communication, and ensure regulatory compliance in order to foster efficient and effective regulatory operations.
Certificate of Suitability: This document is issued by regulatory authorities to confirm that a pharmaceutical substance complies with the applicable quality standards. A Certificate of Suitability is crucial in order to expedite regulatory approval processes, ensuring product quality, and fostering the acceptance of pharmaceutical substances globally.
Good Manufacturing Practices (GMP) Certificate: This certificate attests that a manufacturing facility complies with safety and quality standards for pharmaceutical production. Obtaining a GMP certificate is critical for demonstrating adherences to industry regulations, ensuring product safety and facilitate trade on a global scale.
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