Product Information Services:

SmPC and PIL Review:

Thorough Review:

Our experienced team conducts a thorough review of your SmPC and PIL documents to ensure that they are accurate, complete, and compliant with regulatory requirements.

ERA identifies any discrepancies or areas for improvement.

Regulatory Compliance:

We ensure that your SmPC and PIL documents adhere to the latest regulatory guidelines and requirements in the target markets.

ERA assists in addressing any regulatory queries or concerns related to product information.

Guidance and Updates:

Strategic Guidance:

ERA provides strategic guidance on optimizing the content and format of your SmPC and PIL documents to enhance clarity and user-friendliness.

We help you align product information with the needs of healthcare professionals and patients.

Timely Updates:

Our team assists in the timely update of SmPC and PIL documents in response to changes in product labelling, safety data, or regulatory requirements.

ERA ensures that your product information remains current and compliant.

Labelling and Mock-ups:

Labelling Review:

We review product labels and mock-ups to verify their accuracy and compliance with regulatory labelling requirements.

ERA identifies any discrepancies and provides guidance for improvements.

Submission Support:

ERA assists in the submission of updated labelling and mock-ups to regulatory authorities when necessary.

We ensure that submissions are complete and comply with regulatory requirements.

Quality Control:

Stringent Quality Control:

ERA implements rigorous quality control processes to maintain the precision and integrity of product information.

We minimize the risk of errors or discrepancies in product labelling and documentation.

By partnering with ERA for Product Information Services, you gain a trusted partner dedicated to ensuring that your product information is accurate, compliant, and user-friendly. Our commitment to review, guidance, updates, and quality control helps you maintain the highest standards in product information, facilitating safe and effective product use.