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Regulatory Staffing Services

Offering Staffing Excellence with the Best in Regulatory Talent for Smooth Regulatory Operation

We offer expertise, flexibility and compliance by our regulatory staffing services

In today’s complex and dynamic regulatory environment, pharmaceutical and medical device manufacturer endure significant challenges in ensuring adherence and protecting confidentiality of proprietary data pharmaceuticals, hence they seek assistance of external regulatory services to maintain the complete visibility over daily regulatory actions. Understanding these challenges, we offers comprehensive regulatory staff services to protect sensitive information, ensure transparency in regulatory proceedings, and provide professional assistance.

Zenovel, your regulatory contract staffing partner, will promptly address resource shortages by effectively allocating resources to meet your client’s needs.

  • We provide the services
  • Regulatory Strategist
  • Regulatory consultation during product development and manufacturing,
  • Designing specifications, protocols, and reports, confirming composition against reference drugs, and interacting with stakeholders.
  • Interacting with Health Authorities, providing regulatory submission strategies, managing teams, and filing submissions
  • Handling Health Authority queries with strategies and scientific justifications, acting as the interface between management and Regulatory affairs teams.
  • Regulatory Associate
  • Authoring CMC modules for initial submissions and packages for post-approval submissions.
  • Evaluating change controls.
  • Tracking submission timelines.
  • Providing a document checklist for regulatory submissions.
  • Implementing submission strategies.
  • Managing submission timelines & quality.
  • Implementing document checklists.
  • Coordinating with stakeholders for missing documents.
  • Conducting knowledge-sharing sessions.
  • Tracking submissions.
  • Managing timelines.
  • Preparing responses to Health Authority queries.
  • Regulatory Expert
  • Preparing and executing regulatory submission strategies.
  • Evaluating change controls, & providing a document checklist for all types of submissions.
  • Regulatory consultation during product development & manufacturing phases.
  • Designing specifications, protocols, reports, and confirming composition against reference drugs.
  • Gap analysis and regulatory assessment of generated source data.
  • Reviewing draft CTD sections for initial & post-approval submissions.
  • Guiding stakeholders on regulatory requirements.
  • Managing the team to track submissions, quality deliveries, & meeting timelines.
  • Providing guidance on regulatory updates.
  • Preparing response submission strategies for HA queries.
  • Why choose Zenovel RI services?
  • Avenue to specialized knowledge
  • We offer tailored solutions across various therapeutic areas and product types.
  • Ensuring compliance and strategic advantage through their extensive knowledge of global regulations and industry standards
  • Economical
  • We assist to reduce overhead costs and efficiently allocate resources to critical activities.
  • Swiftness and Effectiveness
  • Rapid hiring and onboarding processes minimize disruption to regulatory operations.
  • Regulatory experts ensure timely and accurate submissions, reducing the risk of delays and non-compliance.
  • Confidentiality and Security

Prioritize the confidentiality of your proprietary information and implementing robust data protection measures.

Reach out to us for any inquiries or support needs.
Contact us

Blogs and news

Our Latest Article

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FDA’s Approach to Nitrosamine Control: Innovative Solutions for Drug Safety and Compliance

Understanding Nitrosamine Impurities in Pharmaceuticals: Nitrosamines, particularly N-nitrosamines, are probable or possible human carcinogens. They can form during the synthesis of active pharmaceutical ingredients (APIs) or during the storage of finished drug products. FDA guidance emphasizes the need for risk assessment, mitigation strategies, and regulatory compliance to control nitrosamine levels.

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Nitrosamine Control

In-Process Monitoring for BA/BE Studies: A Focus on DDIs

Introduction: In-process monitoring is a critical component of ensuring the quality and reliability of BA/BE studies, especially those involving drug-drug interactions (DDIs). For DDI studies, in-process monitoring is particularly crucial due to the complex nature of interactions, the need for precise data, and the potential impact on patient safety. Key

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Risk-Based Monitoring

Revolutionizing Clinical Trial Monitoring: The Power of Risk-Based Monitoring (RBM)

Abstract For the past few years, regulatory bodies, industry advocacy groups, and private companies have been tackling the concept of incorporating risk into the design of clinical trials and customizing monitoring strategies based on those risks to achieve higher-quality outcomes. Regulatory guidance like ICH and FDA encourag sponsors to adopt

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Mastering Inhalation Studies

Mastering Inhalation Studies: A Closer Look at Challenges and Solutions

Introduction In the realm of inhalation studies, achieving consistent compliance and accurate results is a considerable challenge due to the complexities associated with trial conduct. Zenovel, a third-party monitoring company, boasts extensive experience in monitoring inhalation studies. This article sheds light on Zenovel’s recent involvement in the monitoring of three

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Data integrity

Ensuring Data Integrity: Best Practices and Considerations

Introduction There are multiple definitions of data integrity, yet the essence is the same. Data integrity is the overall accuracy, completeness, and consistency of data. Data integrity is the maintenance of, and the assurance of the accuracy and consistency of data over its entire life-cycle and is a critical aspect

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GCP Audit and Monitoring

Enhancing Clinical Studies with GCP Audit and Monitoring

Understanding GCP Audit and Monitoring GCP guidelines set forth by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) provide a framework to ensure the ethical conduct, safety, and quality of clinical trials. Audit and monitoring are essential components of GCP compliance and play a

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We provide affordable, innovative, and high-quality solutions to pharma industry with ethics driven research and increasing accessibility to high quality medicine worldwide
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  • India
  • Australia
  • 9, Blaxland Avenue,
    Cranbourne North,
    Victoria-3977, Australia
  • Brazil 
  • Rua Praia do Tubarão, Quadra C,Loteamento Eco Vilas, Lote 13 – Vilas do Atlântico 42708-730 Lauro de Freitas, Bahia, Brazil
  • Brazil 
  • R. Álvaro Müler, 932 - Vila Angelino Rossi, Campinas-SP,13023-240, Sao Paulo, Brazil.
  • USA
  • 911 Hwy 6 Hitchcock,
    Texas, 77563, USA
  • Canada
  • 215 Moorlands Crescent,
    Kitchener, Ontario N2P 0C3
  • China
  • Zhenjiang Tech Park, Shanghai China
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