Regulatory Strategy and Guidance

Strategic Planning:

Tailored Regulatory Strategy:

We work closely with you to develop a regulatory strategy that aligns with your product’s development goals and target markets.

ERA ensures that your strategy considers regulatory pathways, timelines, and potential challenges.

Market Access Insights:

We provide valuable insights into market access trends, reimbursement policies, and pricing strategies that can impact your regulatory strategy.

Our experts help you make informed decisions to optimize market entry.

Regulatory Roadmap:

Comprehensive Guidance:

ERA offers guidance on regulatory requirements, submissions, and interactions with regulatory authorities.

We provide support at every stage of product development, from early development to post-marketing.

Regulatory Intelligence:

Our team stays updated with the latest regulatory changes and trends, ensuring that your regulatory strategy remains current and effective.

ERA proactively addresses changes to minimize regulatory risks.

Renewals

Timely Renewal Management:

ERA manages the renewals of marketing authorizations, ensuring that your products maintain regulatory compliance and market access.

We help you prepare and submit renewal applications in a timely manner.

Repeat Use Procedures

Procedure Planning:

We guide you through the planning and execution of repeat use procedures, including post-approval changes and variations.

ERA ensures that your procedures are strategically aligned with your regulatory goals.

Documentation and Submission:

ERA assists in preparing and submitting repeat use procedure documentation to regulatory authorities.

We ensure that your submissions are comprehensive and meet regulatory expectations.

Regulatory Compliance:

Our team ensures that repeat use procedures comply with the latest regulatory guidelines and requirements.

ERA proactively addresses any regulatory queries or concerns.

By partnering with ERA for Regulatory Strategy and Guidance, Renewals, and Repeat Use Procedures, you gain a trusted advisor dedicated to optimizing your regulatory pathway. Our commitment to strategic planning, documentation excellence, regulatory compliance, and ongoing support ensures that your products meet regulatory requirements and maintain market access.