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Regulatory Consulting & Strategic Services

Navigating Strategic Insights for Regulatory Excellence

We guide regulatory compliance and drive innovation with our services.

We, Zenovel offer strategic insights and expertise to help businesses navigate the regulatory landscape, meet standards, accelerate market entry, and achieve long-term success.
  • Overview

The pharmaceutical sector faces two common problems: efficient use of time and resources, and compliance with regulatory strategies. Having knowledgeable regulatory strategy and regulatory affairs consulting services is crucial for overcoming obstacles in drug development and product commercialization processes.

Zenovel provides top-tier Regulatory Consulting and Strategic Services to help businesses navigate regulatory affairs. Our team of experts provides comprehensive guidance, strategic planning, and ensures products meet regulatory requirements, maximizing efficiency and market readiness.

  • Our Expertise in Regulatory Consulting & Strategic Services
  • Preparation and submissions for an array of international regulatory applications.
  • Regulatory compliance guidance in response to CRLs and agency inquiries.
  • Biological licence applications (BLAs) and marketing authorization applications (MAAs) for vaccines, recombinant therapeutic proteins, and other biological advanced treatment goods such stem cells and tissue-based products are prepared and submitted.
  • Support from CMC consultancy for the creation and filing of regulatory dossiers, including IMPD, DMF, ASMF, ANDAs, INDs, NDAs, and MAAs.
  • A strategy for submitting regulatory applications to expand a medicine into a new market.
  • Regulatory compliance advisory services for post-approval modification implementation.
  • Regulatory guidance for communications with HAs prior to submission.
  • Competitive landscape analysis and the development of appropriate mitigation/regulatory solutions for product registrations prior to the use of accelerated programme requests.
  • Regulatory Affairs consulting for accelerated programmes and Orphan Drug Designation (ODD) applications.
  • CMC consultancy for reports and procedures related to Quality by Design (QbD).
  • CMC consultation for biological product and biosimilar development.
  • Consultation services for pharmaceutical regulations in order to access new markets.
  • Regulatory advice for addressing problems with the development of a combined product (Device + Drug/Biologic).
  • CMC consultancy and stability research specifications taking matrix and bracketing ideas into account.
  • Regulatory approach and worldwide market RMP identification.
  • Determining the European submission procedure.
  • Consulting on regulatory matters while choosing a Reference Member State (RMS).
  • Advising on regulatory compliance while answering HA inquiries.
  • Support for consulting on changes to medication formulation or administration routes and dossier registration with HAs (e.g., 505b (2), hybrid applications, etc).
  • Our Expertise in Regulatory Consulting & Strategic Services
  • Preparation and submissions for an array of international regulatory applications.
  • Regulatory compliance guidance in response to CRLs and agency inquiries
  • Biological licence applications (BLAs) and marketing authorization applications (MAAs) for vaccines, recombinant therapeutic proteins, and other biological advanced treatment goods such stem cells and tissue-based products are prepared and submitted.
  • Support from CMC consultancy for the creation and filing of regulatory dossiers, including IMPD, DMF, ASMF, ANDAs, INDs, NDAs, and MAAs.
  • A strategy for submitting regulatory applications to expand a medicine into a new market.
  • Regulatory compliance advisory services for post-approval modification implementation.
  • Regulatory guidance for communications with HAs prior to submission.
  • 505b (2), hybrid applications, etc.).
  • Competitive landscape analysis and the development of appropriate mitigation/regulatory solutions for product registrations prior to the use of accelerated programme requests.
  • Regulatory Affairs consulting for accelerated programmes and Orphan Drug Designation (ODD) applications.
  • CMC consultancy for reports and procedures related to Quality by Design (QbD).
  • CMC consultation for biological product and biosimilar development.
  • Consultation services for pharmaceutical regulations in order to access new markets.
  • Regulatory advice for addressing problems with the development of a combined product (Device + Drug/Biologic).
  • CMC consultancy and stability research specifications taking matrix and bracketing ideas into account.
  • Regulatory approach and worldwide market RMP identification.
  • Determining the European submission procedure.
  • Consulting on regulatory matters while choosing a Reference Member State (RMS).
  • Advising on regulatory compliance while answering HA inquiries.
  • Support for consulting on changes to medication formulation or administration routes and dossier registration with HAs (e.g.,
  • Why Choose Zenovel ?
  • Unparalleled Expertise
Team of professionals with deep knowledge of regulatory affairs ensure your product adhere with regulatory norms.
  • Strategic Insight
Guide you through anticipate regulatory challenges and seize opportunities, enabling faster and smoother market entry.
  • Strategic Insight
Support your global expansion efforts, ensuring compliance across multiple markets.
  • Comprehensive Assistance
Offer end-to-end support to keep your products compliant and successful.
Reach out to us for any inquiries or support needs.
Contact us

Blogs and news

Our Latest Article

Nitrosamine Control

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.

Read More
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

Read More
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

Read More
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

Read More
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

Read More
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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