QP, RP and Regulatory Affairs
QP and GMP Support
Quality Management System
Quality Management System
We have expertise in the set up of the following facilities: -
- WDA (H)
- MIA
- MIA (IMP)
- MS
A dedicated Qualified Person (QP) providing Project Management and supply chain support
Quality Management System
Quality Management System
Quality Management System
- GAP assessments
- Support with new or impending regulatory updates
- Development of a Quality Management System, bespoke to your needs
- Development of Site Master Files (SMFs) and Quality Manuals (QMs)
- Development of Standard Operating Procedures (SOPs)
- Performing internal audits/ self-inspections
- Performing 'mock' regulatory inspections, or support in the inspection readiness process
QP, RP and Regulatory Affairs
Responsible Person (RP) Services
Responsible Person (RP) Services
Responsible Person (RP) Services
As part of our RP services, we ensure compliance with Good Distribution Practices (GDP) to safeguard the quality and integrity of your pharmaceutical products throughout the supply chain. Our RP responsibilities include:
- Overseeing the implementation and maintenance of GDP standards.
- Ensuring transportation, storage, and distribution activi
As part of our RP services, we ensure compliance with Good Distribution Practices (GDP) to safeguard the quality and integrity of your pharmaceutical products throughout the supply chain. Our RP responsibilities include:
- Overseeing the implementation and maintenance of GDP standards.
- Ensuring transportation, storage, and distribution activities comply with relevant regulations.
- Coordinating with national regulatory authorities for inspections and audits.
- Providing strategic guidance on the distribution of products across multiple markets.
Regulatory Affairs Services
Responsible Person (RP) Services
Responsible Person (RP) Services
- Regulatory Strategy and Submission: Guidance on dossier preparation, submission, and approval processes to ensure compliance with regional and international regulatory requirements, including variations, renewals, and updates.
- Product Lifecycle Management: End-to-end management from preclinical and clinical stages to post-marketing surveil
- Regulatory Strategy and Submission: Guidance on dossier preparation, submission, and approval processes to ensure compliance with regional and international regulatory requirements, including variations, renewals, and updates.
- Product Lifecycle Management: End-to-end management from preclinical and clinical stages to post-marketing surveillance, ensuring products meet regulatory expectations at every step.
- Labeling and Packaging Compliance: Assisting with regulatory-compliant labeling, ensuring that information is clear, accurate, and accessible to patients and healthcare professionals.
- Health Authority Communication: Acting as a liaison with global regulatory bodies like the EMA, FDA, and MHRA, addressing queries and maintaining ongoing compliance.
- Post-Marketing Surveillance: Supporting safety reporting, periodic updates, and responding to health authority requirements to maintain product marketability.