UniCore Solutions - Quality and Regulatory Consultancy

Quality and regulatory Consultancy

At UniCore Solutions LLC., we offer a wide range of Consulting services designed to support our Drugs, Biologicals, and Medical Device clients at each stage of their product life cycle right from Concept, Product Development to Commercialization. We provide Regulatory Affairs Consulting services for Pharmaceuticals, Biologics, Medical Devices, Software as a Medical Device Products, including Regulatory Strategy Development, Clinical Trial support, and submission preparation.

Regulatory Affairs Consultancy

We help clients develop comprehensive Regulatory Strategies that meet their specific needs and ensure timely approvals.

Quality Assurance Consultancy

We provide support for quality system development and implementation, as well as assistance with Regulatory audits and Inspections.

Compliance Consultancy

We provide guidance on a range of compliance issues, including data integrity, product labeling, and pharmacovigilance.

Regulatory Submissions

We ensure that submissions are complete and of high quality, reducing the risk of rejection or delays.