Global Regulatory Services: Comprehensive & Strategic

Our experienced Regulatory professionals serve as your expert guide, proactively tracking and interpreting the constant developments in Pharmaceutical and MedTech legislation across the world. We don’t just report changes; we provide strategic counsel on restraints and requirements, empowering you to choose the optimal market strategy and procedure.

We efficiently manage the entire submission lifecycle: compiling and packaging registration documents and conducting the critical negotiations necessary to successfully obtain and maintain Marketing Authorisation.

With Ipharmed as your dedicated regulatory partner, your product’s compliance and market success are securely managed. We provide full or shared regulatory responsibility across three core phases.

1. Drug Development & Pre-Approval Services

We guide your product from concept to submission, specializing in strategic and technical dossier preparation:

  • Scientific & Regulatory Strategy: Providing Scientific Advice and defining the optimal Regulatory Strategy for your product.
  • Clinical Trials: Managing Clinical Trial Applications (CTA)
  • Marketing Authorisation Applications (MAA): Expertly handling all submission types (USA IND, NDA, ANDA, Centralised Procedure (CP), Decentralised Procedure (DCP), Mutual Recognition Procedure (MRP), National Procedure (NP)).
  • Dossier Excellence: Providing eCTD creation and publishing, conducting Dossier Audits (gap analysis), and coordinating Agency Meetings (e.g., pre-submission / INDs).
  • DMF Compilations: Creation of US /EU DMF, ASMF or CEP Applications.

2. Post-Approval and Lifecycle Management

We ensure continuous compliance and successful lifecycle maintenance after your product reaches the market:

  • Maintenance & Updates: Managing Annual Reports, Variations (changes), and Renewals of existing authorisations.
  • Pharmacovigilance & Safety: Preparing and reporting PADERs and managing Periodic Benefit-Risk Evaluation Reports (PBRER).
  • Market Access Support: Preparing Price and Reimbursement Applications to secure market accessibility.

3. Region-Specific Regulatory Support

Leveraging our global base, we provide specialized services essential for operating major countries:

  • US Agent Services: Provides support to act as US agent for IND/NDA/ANDA or
  • Local Representation: Offering UK/EU MA Holding and Authorised Representative services.
  • Quality Assurance: Providing BR/BT Services, MIA and Qualified Person (QP) Services for EU distribution.
  • Product Information Management: Handling Translations & updates of product information, Mock-up reviews, and Marketing (promotional) material reviews (IMA certified).