The responsibilities of staying compliant with the Good Pharmacovigilance Practice (GVP), managing Individual Case Safety Reports (ICSRs), and preparing for pharmacovigilance inspections stretch your resources thin, leading to unanticipated roadblocks. This is where leveraging the expertise of a professional service provider like us makes a difference. When you outsource pharmacovigilance services you can stay on top of drug safety and efficacy monitoring without worrying about the operational complexities.

Uniquely positioned to alleviate your specific challenges, our pharmacovigilance company has a team of physicians, medics, and medical writers, proficient in managing diverse product portfolios spanning pharma, vaccines, cosmetics, medical devices, and combination products. Our flexible solutions cater to everything from assisting individual activities to setting up and managing an efficient global pharmacovigilance system.

Stay compliant with the drug regulatory standards and free up your internal resources by choosing us as your pharmacovigilance service provider.

Client Success Stories

Testimonials

Clients Speak

Hello, I wanted to reach out to you directly and express my gratitude for the hard work that the Data team, as well as the AR team, has done with EJ practice. I have pushed both teams extremely hard over the past month and their efforts, as well as ours, have paid off.

RCM Account Manager,
EMR System Provider, FL, USA

Our Custom Pharmacovigilance Services

Our capabilities in handling complex safety data and deploying effective risk management strategies set us apart. Here is the wide spectrum of online pharmacovigilance services we offer -

• Individual Case Safety Reports (ICSRs)

  
  • Adverse Reaction Reporting
  • Drug-related Problem Management
  • Regulatory Filing Compliance

• Literature Monitoring

  
  • Identify adverse reactions from medical literature
  • Scan clinical publications using advanced techniques
  • Product safety assessments and decision-making

• Aggregate Reporting

  
  • Detailed safety reports
  • Evaluate the risks and benefits of drugs
  • Support regulatory submissions

• Signal Detection and Management

  
  • Identify safety signals from various data sources
  • Strategies to mitigate potential safety issues
  • Safeguard patient health

• Risk Management Plan (RMP)

  
  • RMPs to minimize drug risks
  • Risk communication and mitigation strategies
  • Enhance patient safety

• Pharmacovigilance Audit and Training

  
  • Conduct safety audits
  • Provide compliance training
  • Implement corrective actions

• Safety Database Solutions

  
  • Build safety databases
  • Conduct data analysis
  • Maintain data integrity

• Medical Device Vigilance

  
  • Monitor device safety
  • Report adverse events
  • Manage risk assessments

• Regulatory Intelligence and Consulting

  
  • Gather regulatory insights
  • Gather regulatory insights
  • Ensure compliance management

Steps We Follow to Provide Pharmacovigilance Assistance

We implement a systematic approach to seek, collect, and evaluate information from healthcare providers and patients to ensure the safety and efficacy of pharmaceutical products. The steps in our approach include -

Pharmacovigilance Consulting Services We Offer

Our remote advisory services address key issues such as the integration of pharmacovigilance systems with clinical research. We provide insights into managing safety data in special populations, such as geriatric or pediatric patients, . Our professional consultancy team also helps clients navigate the field of pharmacovigilance in medical devices, an area of increasing regulatory focus. Our strategic thinking and operational excellence ensure that our clients are well-equipped to manage their obligations and protect patient safety.

Our Technology Expertise

Clients We Cater to

Why Should You Choose Our Pharmacovigilance Outsourcing Company?

We bring a unique blend of expertise, technology, and innovative thinking to ensure the highest standards of drug safety. Here are some of the top factors that set us apart -

• HIPAA Compliance

  Our HIPAA-compliant professional services ensure patient data privacy and confidentiality, while adhering to international pharmacovigilance regulations, safeguarding your reputation.

• Access to Expertise in Drug Safety

  Ensure stakeholder loyalty and trust by leveraging our expertise by maintaining the highest standards of drug safety.

• Mitigating Risks in Drug Safety

  Our team helps you identify and manage potential risks associated with drug safety, thereby protecting the interests of patients and your company.

• 24/7 Drug Reaction Monitoring

  Expert clinicians monitor adverse drug reactions round-the-clock, contributing to enhanced patient safety and improved drug efficacy.

• Flexible Pricing

  Partnering with our pharmacovigilance consulting firm that leverages the latest tech and years of experience ensures you get various affordable pricing options.

Recommended Reading Resources

Additional Services You Can Benefit From

Strategic Pharmacovigilance for Enhanced Drug Safety

Our pharmacovigilance solutions provide complete support for your drug safety needs. We specialize in risk management plans, a crucial tool that lets you identify, characterize, and minimize potential and known risks. We also offer comprehensive post-marketing surveillance services, which are essential for tracking the safety and efficacy of your products once they are launched. Our team ensures that any adverse events or other safety concerns are promptly detected, reported, and adequately addressed. This helps you to consistently meet the regulatory standards of drug safety.

Choose us as your business partner to transform safety from merely a regulatory obligation into a strategic asset.