Regulatory Affairs Services

At Privaan Health, we specialize in providing comprehensive regulatory affairs consulting services to clients across diverse industries. With a focus on compliance, quality, and efficiency, we are your trusted partner in navigating the complex landscape of regulatory requirements.

Regulatory Strategy Development:

We work closely with clients to develop customized regulatory strategies tailored to their unique products and markets. Our expertise ensures that regulatory hurdles are anticipated and addressed proactively.

Product Registration and Submissions:

From initial product registration to post-market compliance, we manage all aspects of regulatory submissions like Dossier gap Analysis/due diligence, Pre-submission Meeting, CTD modules writing, Dossier reformatting, Local RA support, Variations (Major, minor, Separate, Groupings), Renewals/re-registrations Withdrawal/Cancellation of Marketing Authorization/Sunset clause application, Marketing Authorization transfer

Quality Management Systems (QMS) Implementation:

We assist companies in establishing and optimizing their quality management systems to ensure compliance with global regulatory standards, such as ISO 13485, ISO 9001, and GMP.

Labelling and Packaging Compliance:

Our team provides comprehensive support in preparation and review of labelling texts and mock-ups/artworks ensuring that product labelling and packaging meet regulatory requirements