A DEEP UNDERSTANDING OF MHRA COMPLIANCE REQUIREMENTS

SEERPHARMA UK and the
MHRA-APPROVED COMPLIANCE MONITOR PILOT

The MHRA are now piloting a scheme whereby businesses that fail to comply with GMP or GDP after an inspection can be overseen by an independent monitor (CM) to help them focus on remediation.

 We are pleased to announce that a number of consultants working for SeerPharmaUK have been deemed eligible by the MHRA to act as Compliance Monitors (CM) in MHRA’s pilot compliance monitor programme for GDP remediation supervision activities.

Should your business find itself in this position following an inspection, and you are offered this option, you are entitled to choose which CM you wish to work with from the MHRA panel.

Contact us to learn more about this pilot scheme

CONSULTANCY

Leveraging SeerPharma’s extensive experience across the global pharmaceutical industry, you can benefit from our ability to quickly understand your areas of operation and then provide highly tailored and practical advice and solutions. With a thorough working knowledge of all relevant industry regulations and guidance, we help clients like you implement effective, compliant and quality-led business practices to bring you greater success now and in the future.

Here’s how we help businesses like yours:

GxP consultancy

Whatever your compliance problem or need we can help you find the solution.

Our initial telephone consultation is provided free of charge and it is during this call that we scope out your needs and detail the options available to you.

Once we’ve agreed the scope, we will then provide you with a formal and clearly priced project proposal. Where appropriate, we will name the specific leading professional we will entrust with the work so that you can be sure of their depth of experience and find confidence in their impeccable credentials.

SeerPharma UK is all about providing the most  experienced and qualified industry professionals and all our work is driven by this benchmark, no exception.

Regulatory and Quality Assurance Advice and Support

We can help you:

  • Prepare for or respond to a regulatory inspection
  • Overhaul your quality system
  • Add a function to your licence (e.g. export, cold chain)
  • Gap analysis
  • Guidance on changes in regulations and regulatory guidance
  • eQMS

Technical Advice and Support

We can help you:

  • Choose a logistics partner
  • Choose equipment (e.g. cold chain)
  • Validate (e.g. transport)
  • Temperature mapping
  • Computer systems validation

Contract RP/RPi

We can help you:

  • Experience of a wide range of operations and business models within the UK Pharmaceutical Supply Chain
  • Current experience as RP

Audits and Mock Inspections

We can help you:

  • Conduct mock inspections
  • Audit to your specific requirements
  • Conduct external audits on your behalf
  • Mentor you through effective self-inspections

Effective Workplace Learning

We can help you:

  • Use our postgraduate teaching and Learning expertise to:
    – Identify appropriate Learning Paths for all staff
    – Focus on employee strengths to realise higher engagement and learning
  • Develop true Continued Professional Development
  • Help you develop evidence-based assessment of the effectiveness of training
  • Assess the suitability of a Responsible Person

Contact us to learn more about this pilot scheme