X Pharma Plus is a leading provider of Regulatory and medical affairs services for all categories of medicinal product registration and lifecycle management. Our Regulatory experts possess real-time experience in managing end-to-end registrations for medicinal products, particularly with major Health Authorities (HAs) such as the US FDA, EMA, and Health Canada. This expertise enables sponsors and manufacturers to achieve hassle-free registration of their medicinal products across key global markets, ensuring a smooth product launch, compliance, and ongoing lifecycle maintenance.
Global Health Authorities-Specific Services – Overview
Navigating the complex Regulatory landscape of the life sciences industry requires deep industry insights and unparalleled expertise. X Pharma Plus provides comprehensive Regulatory services globally, ensuring that your medicinal drug products—pharmaceuticals (Rx/OTC) and biologicals—comply with stringent Regulatory requirements, current guidelines, and achieve successful approvals and market entry.
Specializing in 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 include technical review, finalization, and submission of complete Regulatory packages to meet global standards and Health Authority-specific requirements.
Pre-submission support encompasses Regulatory strategic submission planning, Regulatory roadmaps, and comprehensive reviews to ensure all requirements are fulfilled. X Pharma Plus also provides guidance across clinical, non-clinical, labeling, artwork, pharmacovigilance, and electronic publishing and submission domains, delivering true end-to-end registration support.
Global Health Authorities-Specific
Services Expertise
X Pharma Plus brings specialized expertise in navigating diverse regulatory frameworks across major global Health Authorities (HAs), ensuring successful medicinal product registration and compliance throughout the lifecycle. Our team has hands-on experience
Food and Drug Administration (FDA)
X Pharma Plus provides end-to-end regulatory support for U.S. FDA submissions, ensuring compliance with the latest guidelines and standards.
Our expertise covers:
- Regulatory Submissions: Investigational New Drug (IND), New Drug Application (NDA), Abbreviated New Drug Application (ANDA), Biologics License Application (BLA), Over the counter (OTC) Monograph compliance.
- Electronic Submissions: eCTD preparation, publishing, and ESG gateway submissions.
- Clinical & Non-Clinical Support: Guidance on study design, safety reporting, and data requirements.
- Labeling & Artwork Compliance: Development and review to meet FDA standards.
- Post-Approval/Lifecycle Management: Variations, supplements, renewals, and pharmacovigilance compliance.
- Quality & Risk Management Services: Nitrosamine Impurity Risk Assessment, Impurity Profiling & Control Strategies, Risk-Based Approaches to GMP
With our deep knowledge of FDA processes, we help sponsors streamline product development, secure approvals efficiently, and maintain long-term regulatory compliance in the U.S. market.
European Authorities (EU)
X Pharma Plus provides comprehensive regulatory support for medicinal product registrations and lifecycle management within the European Union (EU). Our expertise focuses on working with the European Medicines Agency (EMA) and national competent authorities (NCAs) to ensure smooth approvals and compliance with EU regulations.
Our EU regulatory expertise includes:
- Centralized Procedure (CP): Single EU-wide approval for innovative medicines, biologicals, and advanced therapies.
- Decentralized Procedure (DCP) & Mutual Recognition Procedure (MRP): Streamlined registrations across multiple EU member states.
- National Procedure (NP): Country-specific authorizations where required.
- Dossier Preparation & eCTD Publishing: Compilation, formatting, and submission of CTD/eCTD applications.
- Variations & Lifecycle Management: Post-approval changes, renewals, pharmacovigilance reporting, and compliance with EU safety regulations.
- Labeling & Artwork Compliance: Ensuring harmonized EU labeling, translations, and patient information leaflets.
- Active Substance Master File (ASMF) Submissions – Detailed documentation to support the quality and safety of active substances.
- Certification of Suitability (CEP): Submissions to the European Directorate for the Quality of Medicines (EDQM) to demonstrate API compliance with Ph. Eur.. standards.
- EU Marketing Authorization Application (MAA): Preparation and submission of applications for new medicinal products across the EU.
- Investigational Medicinal Product Dossier (IMPD): Preparation of dossiers to support clinical trial applications in Europe.
By leveraging our in-depth knowledge of EMA guidelines, EU directives, and local NCA requirements, X Pharma Plus enables sponsors to achieve faster market access, streamline submissions, and ensure long-term compliance in the European market.
Health Canada
X Pharma Plus offers comprehensive regulatory support for medicinal product submissions and lifecycle management in Canada, ensuring compliance with Health Canada requirements and guidance. Our expertise encompasses both human pharmaceuticals and biologicals, enabling sponsors to achieve timely approvals and maintain long-term regulatory compliance.
Our Health Canada regulatory expertise includes:
- New Drug Submission (NDS): Complete submission for new active ingredients or innovative medications.
- Abbreviated New Drug Submission (ANDS): Applications for generic products demonstrating bioequivalence to reference drugs.
- Drug Identification Number (DIN) Applications: Support for obtaining DINs required to market drugs in Canada.
- Clinical Trial Applications (CTA): Preparation and submission of documentation to conduct clinical studies in Canada.
- Dossier Preparation & eCTD Publishing: Compilation, formatting, and submission of CTD/eCTD packages via Health Canada’s electronic submission gateway.
- Post-Approval Changes & Lifecycle Management: Supplements, notifiable changes, renewals, and pharmacovigilance compliance.
- Labeling & Packaging Compliance: Development and review of bilingual (English/French) labeling, safety updates, and product monographs.
- Medical Device & Combination Product Submissions: Guidance for products regulated under Health Canada’s device or combination pathways.
By leveraging our in-depth knowledge of Health Canada regulations, submission formats, and review practices, X Pharma Plus ensures streamlined approvals, faster market entry, and sustained compliance in the Canadian market.