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Reliable regulatory solutions for the pharmaceutical sector

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.

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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.

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Regulatory compliance assurance

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Supporting compliance with MHRA, EMA, and global regulatory frameworks across product lifecycles.

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Pharmacovigilance

expertise

Signal detection

Risk management

Safety reporting

Compliance

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Pharmacovigilance

expertise

Signal detection

Risk management

Safety reporting

Compliance

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Pharmacovigilance

expertise

Signal detection

Risk management

Safety reporting

Compliance

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Pharmacovigilance

expertise

Signal detection

Risk management

Safety reporting

Compliance

Patient safety focus

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Robust pharmacovigilance systems designed to detect, assess, and prevent adverse effects.

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Regulatory and compliance expertise.

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.

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Affairs Support

Consultation from healthcare professionals

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.

Access a network of virtual consultation.

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Writing & Documentation

Consultation from healthcare professionals

We deliver accurate, submission-ready regulatory documents—including CTD modules, briefing materials, and responses—ensuring clarity, consistency, and global compliance.

Access a network of virtual consultation.

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Regulatory Intelligence & Monitoring

Consultation from healthcare professionals

We monitor and interpret global regulatory developments to provide timely, actionable insights that inform strategy and confident

decision-making.

Access a network of virtual consultation.

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Quality & Compliance Consulting

We strengthen quality systems, support inspection readiness, and manage compliance across the product lifecycle to meet global regulatory

expectations.

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CMC & Technical Affairs

Consultation from healthcare professionals

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.

Access a network of virtual consultation.

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Receive tailored regulatory and safety support aligned to your organisation’s products,
markets, and compliance obligations.

A clear, structured regulatory process.

Step

01

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Initial consultation & scoping

We begin with a focused discussion to understand your product, development stage, target markets, and regulatory objectives.

Step

01

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Initial consultation & scoping

We begin with a focused discussion to understand your product, development stage, target markets, and regulatory objectives.

Step

01

Explore

Initial consultation & scoping

We begin with a focused discussion to understand your product, development stage, target markets, and regulatory objectives.

Step

01

Explore

Initial consultation & scoping

We begin with a focused discussion to understand your product, development stage, target markets, and regulatory objectives.

Step

02

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Regulatory strategy & planning

We develop a clear, globally aligned regulatory strategy covering submissions, health authority interactions, and lifecycle planning.

Step

02

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Regulatory strategy & planning

We develop a clear, globally aligned regulatory strategy covering submissions, health authority interactions, and lifecycle planning.

Step

02

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Regulatory strategy & planning

We develop a clear, globally aligned regulatory strategy covering submissions, health authority interactions, and lifecycle planning.

Step

02

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Regulatory strategy & planning

We develop a clear, globally aligned regulatory strategy covering submissions, health authority interactions, and lifecycle planning.

Step

03

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Execution, and ongoing support

Our teams deliver hands-on regulatory support, ensuring compliant execution, inspection readiness, and across markets.

Step

03

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Execution, and ongoing support

Our teams deliver hands-on regulatory support, ensuring compliant execution, inspection readiness, and across markets.

Step

03

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Execution, and ongoing support

Our teams deliver hands-on regulatory support, ensuring compliant execution, inspection readiness, and across markets.

Step

03

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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.

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Guy Hawkins

Boost in physical

activity levels

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Guy Hawkins

Boost in physical

activity levels

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Guy Hawkins

Boost in physical

activity levels

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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

Our Values

Expert regulatory consulting reduces risk and improves decision confidence.

Expert regulatory consulting reduces risk and improves decision confidence.

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Regulatory insight matters

Clear regulatory strategy and early risk identification help organisations avoid delays, reduce rework, and make confident decisions across development and approval.

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Risk mitigation

Regulatory foresight

Decision confidence

Global alignment

Lifecycle planning

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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?