Affiliate Based Outsourcing Model for Regulatory Affairs.

Affiliate based Outsourcing Model for Regulatory Affairs works as a replacement or an extension of the company’s internal and local RA resources. Many challenges come up from managing your RA activities as sometimes their processes are not harmonized across different countries, the resources are not cost-optimized or simply there isn’t enough of them.

The purpose of this webinar is to share practical tips and insights on the effective optimization of local RA setup, management and relevant costs.

Struggling to optimize your local RA setup?

Learn how we can support you to harmonize processes, optimize resources, and manage costs effectively with the ABO model.

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Pharmacovigilance outsourcing for boosting compliance and safety for biotech companies

In 2025, pharmacovigilance outsourcing has become essential for biotech companies working to stay compliant and protect patient safety. The European Medicines Agency’s latest report showed a nearly 29% increase in inspections, underscoring the rise in regulatory...

Breaking the Silos Across Medical Information & Pharmacovigilance – Leveraging Technology for Operational Efficiency

With the rise of complex therapies and personalised medicines, the demand for robust medical and safety data analysis has surged. This whitepaper explores how integrated PV/MI processes, using a Single Source of Truth (SSOT) framework, can meet this demand, while...

Whitepaper: Computerised System Validation & Pharmacovigilance

Gain insights into optimised CSV solutions, and their role in effective risk management. Key Highlights: In-depth CSV risk management strategies Ensuring data integrity and reliability in PV systems Case study on validating a cloud-based safety database At Biomapas,...

Big Enough To Cover All Your Needs. Small Enough To Care.

Discover the tailored solutions that Biomapas provides to accelerate your clinical trials and optimize your drug development process.

Affiliate-Based Outsourcing

CSV For Pharmacovigilance Systems

Early Phase Oncology

Functional Service Provision

M&A Support

Clinical Research

Regulatory Affairs

Pharmacovigilance

Medical Information

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Big Enough To Cover All Your Needs.
Small Enough To Care.

Clinical Research

Pharmacovigilance

Regulatory Affairs

Medical Information

Quality Assurance

Affiliate Based Outsourcing Model for Regulatory Affairs.

Struggling to optimize your local RA setup?

Pharmacovigilance outsourcing for boosting compliance and safety for biotech companies

Breaking the Silos Across Medical Information & Pharmacovigilance – Leveraging Technology for Operational Efficiency

Whitepaper: Computerised System Validation & Pharmacovigilance

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Big Enough To Cover All Your Needs. Small Enough To Care.

Clinical Research

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Big Enough To Cover All Your Needs.Small Enough To Care.

Clinical Research

Pharmacovigilance

Regulatory Affairs

Medical Information

Quality Assurance

Affiliate Based Outsourcing Model for Regulatory Affairs.

Struggling to optimize your local RA setup?

Pharmacovigilance outsourcing for boosting compliance and safety for biotech companies

Breaking the Silos Across Medical Information & Pharmacovigilance – Leveraging Technology for Operational Efficiency

Whitepaper: Computerised System Validation & Pharmacovigilance

Big Enough To Cover All Your Needs. Small Enough To Care.

Clinical Research

Regulatory Affairs

Pharmacovigilance

Medical Information

Clinical Trials

PV System & QPPV

Post-Authorization

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Big Enough To Cover All Your Needs.
Small Enough To Care.