Reliable regulatory solutions for the pharmaceutical sector
Regulatory solutions pharmaceuticals
Where regulatory expertise meets patient safety.
Where regulatory expertise meets patient safety.
From regulatory strategy to pharmacovigilance, we help pharma and biotech navigate compliance.
From regulatory strategy to pharmacovigilance, we help pharma and biotech navigate compliance.
Why Pharma Consultants Ltd?
Why Pharma Consultants Ltd?
Pharma Consultants Ltd provides expert regulatory consulting and pharmacovigilance services designed to help organisations meet global compliance requirements. From early development to post-marketing surveillance, we support informed decision-making while prioritising patient safety.
Pharma Consultants Ltd provides expert regulatory consulting and pharmacovigilance services designed to help organisations meet global compliance requirements. From early development to post-marketing surveillance, we support informed decision-making while prioritising patient safety.
Regulatory compliance assurance
Supporting compliance with MHRA, EMA, and global regulatory frameworks across product lifecycles.
k+
Pharmacovigilance
expertise
Signal detection
Risk management
Safety reporting
Compliance
Pharmacovigilance
expertise
Signal detection
Risk management
Safety reporting
Compliance
Pharmacovigilance
expertise
Signal detection
Risk management
Safety reporting
Compliance
Pharmacovigilance
expertise
Signal detection
Risk management
Safety reporting
Compliance
Patient safety focus
Robust pharmacovigilance systems designed to detect, assess, and prevent adverse effects.
%
Regulatory and compliance expertise.
Regulatory and compliance expertise.
Expert regulatory affairs, artwork compliance, pharmacovigilance, and quality support for pharmaceutical and biotechnology companies.
Expert regulatory affairs, artwork compliance, pharmacovigilance, and quality support for pharmaceutical and biotechnology companies.
Expert regulatory affairs, artwork compliance, pharmacovigilance, and quality support for pharmaceutical and biotechnology companies.
Strategy & Consulting
We define globally aligned regulatory pathways, manage health authority interactions, and support submissions across the product lifecycle to reduce risk and accelerate time to market.
Affairs Support
We support day-to-day regulatory activities, including submission preparation, health authority correspondence, and lifecycle maintenance, scaling to your needs to deliver compliant, high-quality outputs efficiently.
We support day-to-day regulatory activities, including submission preparation, health authority correspondence, and lifecycle maintenance, scaling to your needs.
Writing & Documentation
We deliver accurate, submission-ready regulatory documents—including CTD modules, briefing materials, and responses—ensuring clarity, consistency, and global compliance.
We deliver accurate, submission-ready regulatory documents - including CTD modules, briefing materials, and responses - ensuring global compliance.
Regulatory Intelligence & Monitoring
Intelligence & Monitoring
Intelligence & Monitoring
We monitor and interpret global regulatory developments to provide timely, actionable insights that inform strategy and confident decision-making.
We monitor and interpret global regulatory developments to provide timely, actionable insights that inform strategy and confident decision-making.
We monitor and interpret global regulatory developments to provide timely, actionable insights that inform strategy and confident decision-making.
Compliance Consulting
We strengthen quality systems, support inspection readiness, and manage compliance across the product lifecycle to meet global regulatory expectations.
CMC & Technical Affairs
We provide expert CMC authoring and advisory support across Modules 2.3 and 3, ensuring data integrity, submission readiness, and effective management.
Quality & Compliance Consulting
Compliance Consulting
We strengthen quality systems, support inspection readiness, and manage compliance across the product lifecycle to meet global regulatory
expectations.
We strengthen quality systems, support inspection readiness, and manage compliance across the product lifecycle to meet global regulatory expectations.
We strengthen quality systems, support inspection readiness, and manage compliance across the product lifecycle to meet global regulatory expectations.
CMC & Technical Affairs
We provide expert CMC authoring and advisory support across Modules 2.3 and 3, ensuring data integrity, submission readiness, and effective post-approval change management.
CMC & Technical Affairs
We provide expert CMC authoring and advisory support across Modules 2.3 and 3, ensuring data integrity, submission readiness, and effective post-approval change management.
Receive tailored regulatory and safety support aligned to your organisation’s products,
markets, and compliance obligations.
Receive tailored regulatory and safety support aligned to your organisation’s products,
markets, and compliance obligations.
A clear, structured regulatory process.
Step
01
Initial consultation & scoping
We begin with a focused discussion to understand your product, development stage, target markets, and regulatory objectives.
Step
01
Initial consultation & scoping
We begin with a focused discussion to understand your product, development stage, target markets, and regulatory objectives.
Step
01
Initial consultation & scoping
We begin with a focused discussion to understand your product, development stage, target markets, and regulatory objectives.
Step
01
Initial consultation & scoping
We begin with a focused discussion to understand your product, development stage, target markets, and regulatory objectives.
Step
02
Regulatory strategy & planning
We develop a clear, globally aligned regulatory strategy covering submissions, health authority interactions, and lifecycle planning.
Step
02
Regulatory strategy & planning
We develop a clear, globally aligned regulatory strategy covering submissions, health authority interactions, and lifecycle planning.
Step
02
Regulatory strategy & planning
We develop a clear, globally aligned regulatory strategy covering submissions, health authority interactions, and lifecycle planning.
Step
02
Regulatory strategy & planning
We develop a clear, globally aligned regulatory strategy covering submissions, health authority interactions, and lifecycle planning.
Step
03
Execution, and ongoing support
Our teams deliver hands-on regulatory support, ensuring compliant execution, inspection readiness, and across markets.
Step
03
Execution, and ongoing support
Our teams deliver hands-on regulatory support, ensuring compliant execution, inspection readiness, and across markets.
Step
03
Execution, and ongoing support
Our teams deliver hands-on regulatory support, ensuring compliant execution, inspection readiness, and across markets.
Step
03
Execution, and ongoing support
Our teams deliver hands-on regulatory support, ensuring compliant execution, inspection readiness, and across markets.
We are trusted regulatory experts helping life sciences organisations navigate global compliance.
Guy Hawkins
Boost in physical
activity levels
Guy Hawkins
Boost in physical
activity levels
Guy Hawkins
Boost in physical
activity levels
Jane Austen
Physical boost
Energy surge
Jane Austen
Physical boost
Energy surge
Jane Austen
Physical boost
Energy surge
Toni Morrison
Stamina rise
Strength gain
Toni Morrison
Stamina rise
Strength gain
Expert regulatory consulting reduces risk and improves decision confidence.
Expert regulatory consulting reduces risk and improves decision confidence.
Regulatory insight matters
Clear regulatory strategy and early risk identification help organisations avoid delays, reduce rework, and make confident decisions across development and approval.
%
Risk mitigation
Regulatory foresight
Decision confidence
Global alignment
Lifecycle planning
Frequently asked questions
Frequently asked questions
Frequently asked questions
Frequently asked questions
For any unanswered questions, reach out to our support team via email. We'll respond as soon as possible to assist you.
For any unanswered questions, reach out to our support team via email. We'll respond as soon as possible to assist you.
For any unanswered questions, reach out to our support team via email. We'll respond as soon as possible to assist you.
For any unanswered questions, reach out to our support team via email. We'll respond as soon as possible to assist you.
What pharmacovigilance services do you provide?
We support safety strategy, case management oversight, signal management, and regulatory safety reporting.
Do you support post-marketing safety activities?
Can you integrate with existing PV vendors or systems?
How do you ensure regulatory compliance in PV?
What pharmacovigilance services do you provide?
We support safety strategy, case management oversight, signal management, and regulatory safety reporting.
Do you support post-marketing safety activities?
Can you integrate with existing PV vendors or systems?
How do you ensure regulatory compliance in PV?
What pharmacovigilance services do you provide?
We support safety strategy, case management oversight, signal management, and regulatory safety reporting.
Do you support post-marketing safety activities?
Can you integrate with existing PV vendors or systems?
How do you ensure regulatory compliance in PV?
What pharmacovigilance services do you provide?
We support safety strategy, case management oversight, signal management, and regulatory safety reporting.
Do you support post-marketing safety activities?
Can you integrate with existing PV vendors or systems?
How do you ensure regulatory compliance in PV?