Publishing & eCTD Services
Overcoming Global Submission Challenges: Pharmaceutical companies consistently face significant operational hurdles in managing global regulatory affairs submissions, including:
- Meeting Complex Timelines: Navigating the dynamic regulatory, patent, and development environments throughout the product lifecycle.
- Regional Variation: Managing the complexity of diverse submission requirements across multiple countries.
IPHARMED Solution: End-to-End Submission Excellence
We transform operational burden into guaranteed compliance and efficiency. Let Us Be Your Publishing and Submission Partner:
| Service Category | Description |
| Dossier Conversion & Migration | Conversion of legacy paper-based submissions and documents into regional/country-specific formats (e.g., NeeS or eCTD). |
| Publishing Team Extension (BPaaS) | Seamlessly extend your in-house publishing capabilities via our Business Process as a Service (BPaaS) model, including submission tool management. |
| Global Submission Management | Comprehensive end-to-end services for Publishing, Submission, and Archival of dossiers across multiple regions (US, UK, EU, Canada, Rest of World). |
| Document Quality & Integrity | Addressing issues related to PDF formatting, hyperlinking, floating sections, and error corrections to ensure technical validation success. |
| Safety & Event Reporting | Efficient management and submission of IND Safety and Adverse Event Reports globally. |
| Formatting & Navigation | Specialized document services including application of Word Style Guides and PDF Navigation standards for high-quality, agency-ready documents. |
Facility Audit (GMP) Services
Building Quality, Ensuring Compliance
In the highly regulated pharmaceutical industry, Good Manufacturing Practice (GMP) is the non-negotiable foundation of patient safety, product efficacy, and global market access. iPharMed delivers comprehensive GMP and Quality Management System (QMS) services designed to establish, maintain, and optimize your compliance posture globally.
We transform compliance from a regulatory burden into a strategic business advantage, ensuring your operations are robust, audit-ready, and aligned with current standards (cGMP).
1. GMP Audits & Inspection Readiness
Minimize risk and ensure continuous readiness with our expert auditing services:
- Third-Party Audits (Due Diligence): Conducting thorough audits of your contract manufacturing organizations (CMOs), contract research organizations (CROs), suppliers, and internal facilities to assess compliance against EU, US FDA, WHO, and PIC/S GMP standards.
- Mock Regulatory Inspections: Simulating inspections by regulatory bodies (e.g., MHRA, FDA, local Ministry of Health – MOH Audit support) to identify and remediate gaps before the official audit occurs.
- Audit Remediation & CAPA: Developing and supporting the implementation of effective Corrective and Preventive Actions (CAPA) plans to address deficiencies and regulatory observations (e.g., FDA 483s or Warning Letters).
2. Quality Management System (QMS) & Validation
A robust QMS is the backbone of compliance. We help you design, implement, and maintain an efficient, scalable system:
- QMS Setup & Optimization: Establishing or optimizing your Pharmaceutical Quality System (PQS) to comply with current GMP standards, including development of Site Master Files (SMF) and Quality Manuals.
- Documentation Excellence: Creation, review, and management of essential GMP documentation, including Standard Operating Procedures (SOPs), Batch Records, Specifications, and Technical Agreements.
- Validation Support: Providing full support for critical validation activities, including Process Validation (PV), Cleaning Validation (CV), and Computer System Validation (CSV).
3. Qualified Person (QP) Services & EU/UK Batch Release
For medicinal products entering the European (EU) and UK markets, the Qualified Person (QP) is the legal guarantor of compliance required for batch certification and release. We offer independent, expert QP oversight to ensure your products meet all regulatory standards swiftly and securely.
Expert QP Oversight:
- EU QP Audit Support: We provide dedicated support to facilitate the QP’s assurance process, including conducting supplier and site audits on behalf of the QP to verify compliance with EU GMP for outsourced activities and sites located outside the EU.
- Batch Certification and Release: Our Qualified Persons conduct a rigorous review and certification of every batch of medicinal product (both commercial and Investigational Medicinal Product – IMP). This certification confirms that the batch was manufactured and tested in accordance with the EU GMP standards (specifically Annex 16) and the relevant Marketing Authorisation (MA) or Clinical Trial Authorisation (CTA).
- QP Declaration & Confirmation: We issue official documentation essential for international trade and specific operations, including QP Declarations for Active Pharmaceutical Ingredient (API) quality and confirmations for specific manufacturing and supply chain activities.
- EU Import Clearance: Facilitating the import and release of products manufactured outside the European Economic Area (EEA), ensuring smooth passage to market.