MRCRO

Regulatory Strategies

Navigate the evolving regulatory landscape of Pakistan for seamless study approval and clinical trial conduct.

1. Regulatory Documents Compilation & IND/CTA Preparation
  • Evaluation of available documents
  • Case preparation for regulatory document compilation
  • Planning & procurement of essential documents as per regulatory requirements
  • Compilation of essential documents for submission
  • Clinical Trial Application (CTA) development
2. Regulatory Submission
  • Submission of essential documents for interventional trials
  • To-and-fro communication with the regulatory body for query resolution
3. Approval Processing
  • Continuous follow-up post submission with the regulatory authority
  • Liaising and obtaining clinical trial approval documents
4. Post-approval Activities
  • Trial-related updates to regulatory body
  • Health authority notifications & study related regulatory updates to sponsor
  • Facilitating sponsor for regulatory inspection
5. Regulatory Consultancy for IND Registration in Pakistan
  • Guidance on local requirements for registration – compliance with local checklists.
  • Expert advice on dossier submissions.
  • Facilitating partnerships with the local pharmaceutical industry for commercialization.

Regulatory Flow & Framework in Pakistan

Total Duration: 21-30 weeks

Trial Insurance

  • Customized coverage for clinical trial participant.
  • Risk assessment and tailored insurance solutions
  • Compliance with international and national level regulations.

IT Solutions

  • Enabling collaborations with the EDC tool vendor.
  • Providing IT-enabled data management support.
  • Integrating data from various sources to facilitate efficient data management.
  • Monitoring site performance for optimizing the use of resources.
  • Maintaining audit trails for tracking changes to ensure data integrity through EDC tools.

Specimen Shipment & Handling

  • Secure and compliant handling of biological specimens.
  • Temperature-controlled packaging and shipping.
  • Collaborative services with global logistics network for specimen transportation.
  • Ensuring regulatory compliance for international shipments.
  • Expertise in managing various specimen types, including blood, tissue, and urine.

Clinical Trial Ancillary Supplies

  • Enabling the sponsors with the ancillary supplies for clinical trials.
  • Comprehensive inventory management and tracking.
  • Customizing supply chain solutions to meet trial-specific needs.
  • Ensuring timely supply services.
  • Providing cost efficient solutions to optimize trial budgets.

IP/ Placebo / Comparator Sourcing

  • In-house services for sourcing of Investigational Products, comparators, and placebos.
  • Collaboration with suppliers and manufacturers.
  • Experienced team for procurement and logistics management.

Central Laboratory Testing

  • Collaborative services for diagnostic and clinical testing.
  • Enabling sponsors to evaluate diverse range of clinical endpoints through diagnostic tests.
  • Meeting quality standards and regional regulatory compliance.
  • Standardized procedures for authentic and credible outcomes.

Percentage Of Total Contributions

Head Office:

Karachi: Plot No. B-10, Block 16, WCHS, KDA Scheme No.24, Gulshan E Iqbal, Karachi – Pakistan.

Regional Office:

Flat No. 2, first floor, 2-C Plaza ( First floor of M.A Dental Clinic) Pakeeza Market, Sector I-8/4, Islamabad, Pakistan

Regional Presence:

  • Sindh
  • Punjab
  • Balochistan
  • Khyber Pakhtunkhwa