Training and Development
Our specialized training programs are designed to keep your regulatory and quality teams up-to-date with the latest industry standards and practices. We offer hands-on training in regulatory filing strategies, quality management systems, and international regulatory requirements (e.g., ICH guidelines).
HOW WE CAN HELP
We’ll ensure that you focus on the opportunities
End-to-end programs.
At PharmAdvis Solutions LLP, we understand the importance of keeping your team up-to-date with the latest regulatory and quality standards. How we can help is by providing customized, end-to-end training programs designed to enhance your team’s expertise and keep them compliant with global regulations. We’ll ensure that you focus on the opportunities for growth and innovation while we deliver training that equips your team with the necessary skills to navigate the evolving pharmaceutical landscape. Our programs are comprehensive, hands-on, and tailored to meet the specific needs of your organization, ensuring continued excellence and regulatory readiness.
Regulatory Filing Strategies
In-depth training on preparing high-quality submissions for global regulatory agencies, including the use of electronic submission platforms (eCTD) and tools for effective dossier management. We cover strategies for NDAs, ANDAs, and biosimilar submissions to ensure smooth regulatory processes.
Inspection Preparedness Training
Tailored programs that simulate regulatory inspections from agencies like USFDA and EMA. Our training ensures teams are well-prepared to handle real-world inspections confidently and effectively, identifying and addressing potential gaps in compliance before audits.
Quality Management Systems (QMS)
Best practices for implementing and maintaining ISO 9001-compliant QMS, with a focus on developing systems that align with current Good Manufacturing Practices (cGMP) standards. We provide guidance on creating robust quality frameworks that ensure regulatory compliance.
Pharmacovigilance Training
Specialized courses on adverse event reporting, signal detection, and preparation of safety documentation in line with global pharmacovigilance regulations. We help your team establish and manage robust pharmacovigilance systems that ensure product safety and regulatory compliance.
ICH Guidelines Compliance
Comprehensive training on ICH Q8-Q11 guidelines, focusing on pharmaceutical development, quality risk management, and continuous improvement. We also offer specialized training on drug substance development (ICH Q11), ensuring compliance throughout the lifecycle of pharmaceutical products.
Risk-Based Auditing and Validation Training
Practical guidance on conducting risk-based internal audits and validation procedures for processes, equipment, and computer systems. Our training ensures that your team can implement and maintain high standards in validation protocols, meeting global regulatory requirements.
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Frequently Asked Questions
We offer specialized training in regulatory filing strategies, quality management systems (QMS), ICH guidelines compliance, inspection preparedness, pharmacovigilance, and risk-based auditing.
Our training programs are designed to be hands-on and interactive, combining theoretical knowledge with practical application. We tailor each program to the specific needs of your organization, ensuring relevance and effectiveness.
Our training programs are ideal for regulatory affairs professionals, quality assurance teams, pharmacovigilance staff, compliance officers, and other professionals involved in the pharmaceutical industry.
Yes, we provide customized training solutions based on your company’s regulatory requirements, quality systems, and operational challenges, ensuring maximum impact and effectiveness.
We offer inspection preparedness training that simulates real-world regulatory audits, helping your team anticipate questions, identify gaps, and implement corrective actions before official inspections occur.
Our trainers are industry experts with decades of experience in regulatory affairs, quality management, and pharmacovigilance. They have extensive backgrounds working with global regulatory agencies such as the USFDA, EMA, and MHRA.
The duration of our training programs varies depending on the topic and depth of the material. Programs can range from one-day workshops to multi-day sessions, depending on your needs.
Yes, participants receive certifications upon successful completion of our training programs, which can be used to demonstrate professional development and regulatory compliance knowledge.
We offer both remote (online) and on-site training options, depending on your preference and geographic location. Our online training sessions are designed to be as interactive and engaging as in-person sessions.
We offer post-training evaluations and assessments to measure the effectiveness of the training program. These include knowledge checks, feedback surveys, and follow-up support to ensure your team applies what they’ve learned.
“PharmAdvis Solutions LLP’s training programs have been a game-changer for our regulatory and quality teams. The customized sessions they provided were incredibly insightful and tailored perfectly to our needs. Their hands-on approach, especially in areas like regulatory filing strategies and inspection preparedness, has significantly boosted our team’s confidence and competence. The trainers’ deep industry knowledge and practical expertise helped us understand complex regulatory requirements and implement effective quality management systems. We are now better equipped to face regulatory audits, and the training on ICH guidelines has improved our operational efficiency. I highly recommend PharmAdvis for any organization looking to enhance their team’s skills and stay ahead of industry standards.”elit, sed do eiusmod.
Viana caranza
Quality Assurance Manager,
Teva Pharmaceuticals Ltd