Regulatory Compliance Support for Temperature-Controlled Pharmaceutical

Environments

We provide specialist regulatory consultancy services to ensure that your temperature-controlled environments are fully compliant with MHRA, FDA, EU GMP, GDP, and ICH guidelines.

Our consultancy offering supports pharmaceutical and biotech companies at every stage of the compliance lifecycle — from facility design and URS development to validation planning, regulatory inspection readiness, and remediation following findings.

We work as an extension of your internal team, aligning engineering delivery with Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP), and supporting full documentation and operational traceability.

When to Engage Our Consultancy Team

New pharmaceutical facility planning

• Expansion, upgrade, or refurbishment of existing temperature-controlled environments
• Audit preparation (MHRA, FDA, EMA, internal QA)
• CAPA response and remediation support
• Validation strategy development
• Documentation support and SOP integration
• Change control involving HVAC, refrigeration, or monitoring systems

We provide expert insight and hands-on support that bridges the gap between engineering and compliance — ensuring your facility is both technically sound and regulatory-ready.

Our Consultancy Services

We help develop or review User Requirement Specifications (URS), ensuring that every system and component aligns with GMP expectations and supports validation.

• URS authoring and technical advisory
• Risk-based requirement definition
• Vendor design package reviews
• BMS and alarm strategy guidance
• Annex 1 and Annex 11 alignment
  

Validation Planning & Protocol Development

We assist with DQ/IQ/OQ/PQ documentation, integrating temperature mapping,

calibration, and test procedures into your overall validation master plan.

• Protocol writing or review
• Risk assessments (FMEA, GAMP5-based)
• Commissioning qualification planning
• Support for FAT/SAT coordination
• Electronic data compliance (21 CFR Part 11)
  

Audit Preparation & Inspection Support

Our consultants support clients before, during, and after inspections by the MHRA,

FDA, EMA and internal auditors.

Mock audits and facility walkthroughs

Gap assessments and remediation planning

Documentation alignment (GxP traceability)

Inspector Q&A preparation

Staff coaching and SOP reviews

We provide actionable insights that allow your team to present a defensible,transparent and compliant operation under regulatory scrutiny.

Remediation After Audit Findings

In cases where temperature control or validation has been highlighted as a critical or major finding, we can act as a technical partner to guide you through remediation.

• CAPA plan development and technical execution
• Redesign or revalidation of existing environments
• Compliance strategy realignment
• Documentation updates and evidence packs
• Stakeholder communication support

Our priority is to help you demonstrate robust, validated controls in a way that meets both regulatory and internal quality expectations.

Bridging Engineering and Compliance

We’re not a paperwork-only consultancy. Our strength lies in our ability to integrate engineering design with real-world regulatory expectations.

• We know how temperature control systems work – and how they’re expected to be validated.
• We understand inspector expectations and can pre-empt issues before they arise.
• We ensure monitoring, alarm and data systems meet both technical and compliance standards.
• We speak the language of quality assurance, regulatory affairs, and validation — as well as engineering.

Who We Work With

Our consultancy services support:

• Pharmaceutical and biotech manufacturers
• CDMOs and third-party logistics providers
• Clinical trial depots and vaccine centres
• QA and validation departments
• Design and build contractors requiring regulatory input
• NHS and government health storage projects

We also support third-party validation teams and internal QA leads in interpreting and applying current MHRA, FDA and ICH guidance to their facilities.

Operating from our base in London, we provide consultancy services throughout the

UK and across Western Europe, including Ireland, Germany, France, the Netherlands, and Spain.

We are familiar with the regional interpretations of EU GMP and have supported

multi-site qualification and harmonisation projects across global pharma networks.