Regulatory Affairs

Our Regulatory Affairs team consists of experienced professionals with a deep understanding of the regulatory landscape across various regions, including the FDA, EMA, and PMDA.
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Regulatory Affairs

Regulatory affairs is a critical function in the healthcare industry, as it ensures that products are safe and effective for patients and consumers. we can offer comprehensive Regulatory Affairs support to our clients. Our Regulatory Affairs team consists of experienced professionals with a deep understanding of the regulatory landscape across various regions, including the FDA, EMA, and PMDA.
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Our Regulatory Services include

Regulatory Strategy Development:

We work with clients to develop an appropriate regulatory strategy based on their product type, intended market, and regulatory requirements.

Regulatory Submissions:

We can prepare, submit, and manage regulatory submissions, including Investigational New Drug (IND) applications, New Drug Applications (NDAs), Biologics License Applications (BLAs), and Marketing Authorization Applications (MAAs).

Labeling and Product Information:

We can provide support for product labeling, including preparation, review, and submission of labeling documents, such as package inserts, prescribing information, and patient information leaflets.

Clinical Trial Applications:

We can assist with the preparation and submission of clinical trial applications, including Investigational Medicinal Product Dossiers (IMPDs) and Clinical Trial Authorization (CTA) applications.

Regulatory Compliance:

We can provide ongoing support to ensure compliance with regulatory requirements, including Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and Good Manufacturing Practice (GMP) regulations.

Post-Marketing Activities:

We can assist with post-marketing activities, including product registration, pharmacovigilance, and adverse event reporting.

Rely on Heliovigil's experienced team for precise and timely regulatory reporting. We navigate the complex regulatory landscape with finesse, delivering high-quality submissions to regulatory authorities with unwavering accuracy.