Address
1st & 2nd Floor 2 West Street, Ware, Hertfordshire, England, SG12 9EE
Our Services
Mock Regulatory GXP Inspections
Our expert team, composed of former regulatory inspectors, conducts customized mock inspections. We provide actionable insights to ensure your facility meets regulatory expectations and is fully prepared for real audits. Whether you need an initial mock inspection prior to a license application or a readiness check, we can provide a solo inspector or a team based on your needs.
In-house training, education, coaching and workshops
Our expert team, composed of former regulatory inspectors, conducts customized mock inspections. We provide actionable insights to ensure your facility meets regulatory expectations and is fully prepared for real audits. Whether you need an initial mock inspection prior to a license application or a readiness check, we can provide a solo inspector or a team based on your needs.
Inspection preparation and inspection support
Our experienced team will guide you through the inspection process from start to finish. We help your staff prepare for inspections, address questions confidently, and handle any compliance gaps. Post-inspection, we support you in responding to observations and ensuring a comprehensive follow-up.
Data Integrity Governance Checks
Strengthen your data integrity with assessments led by our experts. We ensure your governance systems meet regulatory standards and mitigate data-related risks.
Pharmaceutical Quality System (PQS) Maturity Checks
Evaluate the maturity of your PQS with an in-depth analysis conducted by our expert-led team. We ensure your system is robust enough to meet both current and future regulatory demands.
Third-Party Audit management
We manage third-party audits, offering assessments from the best Qualified Persons and former inspectors in the industry. Our team ensures that your external partners meet the highest quality and compliance standard.
Gap Analysis services
We manage third-party audits, offering assessments from the best Qualified Persons and former inspectors in the industry. Our team ensures that your external partners meet the highest quality and compliance standard.
Due Diligence and Technical Support
We dive deep into processes during mergers and acquisitions, uncovering hidden vulnerabilities and compliance gaps. With our team of former inspectors, we ensure you make informed decisions backed by comprehensive assessments.
Associates
TM Pharma Group collaborates with an expanding number of trusted associates, including former inspectors and Qualified Persons, carefully selected for their expertise in GXP services. This ensures our broad range of capabilities and your organisation receives top-quality support.
Annex 1 Sterile Medicinal Products readiness
Our ex-inspector led readiness reviews against the updated annex 1 will provide a detailed analysis of your processes and where any vulnerabilities lie.
Compliance Management and Remediation (including MHRA Compliance Monitors)
In April 2022, the MHRA began a pilot scheme to monitor companies that fail to comply with Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP). Our team includes MHRA-approved Compliance Monitors, ready to guide companies through remediation and compliance protocols under the MHRA’s pilot scheme.
Contamination Control Strategies
We provide expert strategic advice on developing and reviewing Contamination Control Strategies (CCS), ensuring alignment with regulatory frameworks and best practices.
Investigations
Do you need some extra support with investigations? We offer expert consultancy for critical investigations, from product defects to aseptic process simulations (media fill), delivering remote services for maximum flexibility.
Mix and Match
Not sure what your exact needs are? Our experts, including former inspectors, will advise on the most time- and cost-efficient use of our services to meet your specific challenges.
Latest News
Tracy Moore & Andrew Hopkin discuss Annex 1
Tracy Moore from TM Pharma Group Ltd. and Andrew Hopkins, an expert in microbiological contamination control, offer valuable insights and answers to key questions.
Join Tracy at PEC, virtually and in Milan!
There are a number of training events running throughout 2023 where Tracy will be speaking or Training.