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Global Health Authorities–Specific Services
Pharma Wizard is the leading provider of Regulatory and medical affairs services for all categories of medicinal product registration and lifecycle management. Pharma Wizard’s Regulatory experts have real-time experience in getting end-to-end registrations done for medicinal products, especially with the major health authorities (HAs) – US FDA, EMA, and Health Canada. This will help the sponsors and manufacturers with hassle-free registration of medicinal products with the global HAs that include major countries, thus enabling a smooth launch and maintenance of the product in the market.
Global Regulatory Affairs: Authority-Specific Expertise
Navigating the complex Regulatory landscape of the life sciences industry requires industry insights coupled with unparalleled expertise. We at Pharma Wizard provide comprehensive Regulatory services globally, ensuring that your medicinal drug products (pharmaceutical (Rx/OTC), biologicals) comply with stringent Regulatory requirements, current recommendations, and achieve successful approvals and market entry.
We specialize in providing Regulatory expertise for the US FDA, EU, and Health Canada. Our team offers end-to-end support to streamline your product’s journey from development to market entry and beyond.
Our services encompass technical review, finalization, and submission of complete Regulatory packages, ensuring compliance with global standards and specific HA requirements. Our pre-submission support includes Regulatory strategic submission plans, Regulatory roadmap, and comprehensive reviews to ensure all Regulatory requirements are met. Pharma Wizard extends support with regard to clinical, non-clinical, Labeling, Artwork, Pharmacovigilance, and electronic Publishing and Submission domains to provide end-to-end registration support.
We specialize in providing Regulatory expertise for the US FDA, EU, and Health Canada. Our team offers end-to-end support to streamline your product’s journey from development to market entry and beyond.
Our services encompass technical review, finalization, and submission of complete Regulatory packages, ensuring compliance with global standards and specific HA requirements. Our pre-submission support includes Regulatory strategic submission plans, Regulatory roadmap, and comprehensive reviews to ensure all Regulatory requirements are met. Pharma Wizard extends support with regard to clinical, non-clinical, Labeling, Artwork, Pharmacovigilance, and electronic Publishing and Submission domains to provide end-to-end registration support.
Global Health Authorities-Specific Services Expertise
USFDA
- Abbreviated New Drug Application Submissions
- Biologics License Applications Submission
- Drug Master File (DMF) Submissions
- New Drug Application Submission
- Investigational New Drug Applications
- o Nitrosamine Impurity Risk Assessment
European
- Active Substance Master File Submissions
- Centralised Procedure
- Certification of Suitability
- Decentralized Procedure
- EU Marketing Authorization Application
- Investigational Medicinal Product Dossier
- Mutual Recognition Procedure (MRP)
- National Procedure (NP)
Health Canada
- Abbreviated New Drug Submission
- New Drug Submission
- Clinical Trial Application (CTA) Submissions
- Drug Master File (DMF) Submissions
Regulatory Services for Global Health Authorities
- Expertise
- Advantages
- Providing strategic Regulatory consultation
- Drawing Regulatory roadmaps/ pathways
- Strategic guidance during the development stage of the medicinal products
- Preparing and submitting pre-submission meeting packages
- Leading and participating in health authority interactions
- Gap analysis of source documents and providing mitigation guidance for identified gaps
- Authoring of CTD/non-CTD dossiers in line with country-specific requirements
- Providing strategy and preparation of response package to HA deficiencies
- Control assessment and global post-approval submission strategy
- Review and preparation of post-approval variation packages
- Preparation and submission of life cycle management submissions like annual reports and renewals
- Authoring of administrative submissions
- Expert registration support for all types of medicinal products, including biologicals, prescription and OTC pharmaceuticals, innovator and generic drugs, combination products, APIs, excipients, and package materials across all therapeutic categories
- Expert registration support for all dosage forms, such as orals, injectables, ophthalmics, otics, topicals, transdermal patches, inhalers, aerosols, and drugs in all therapeutic categories
- Utilization of in-house developed automation tools to enhance submission accuracy and efficiency
- Proficient in handling end-to-end Regulatory registration activities
- Complete ownership by Pharma Wizard for successful registration and approval
- One-stop solution for all Regulatory registration activities
- Extensive support for expedited review programs and special Regulatory designations
