Regulatory Consulting, Dossier Preparation, Submission, Registration

As Regulatory Agencies (RAs) all over the world started implementing comprehensive Regulatory systems to control the manufacturing and usage of medicinal products, being compliant with stringent requirements is becoming a challenging issue for product registrations and drug approvals. That triggers the need for well-defined Regulatory strategies right from the product development to lifecycle management to addressing all submission requirements, and to comply with the mandatory requirements.

Regulatory Consulting, Dossier Preparation, Submission, Registration

• Strategic planning for a global clinical trial during development of a product

• Strategic planning for entering various regions across the globe

• Strategic planning to take the products approved in one region to other Regulated markets (for example, the USA to Europe or vice versa)

• Stability study planning for all possible presentations / container closure system

• Identification of reference medicinal product as per the global commercialization plan and defining the Regulatory route maps

• Switchover from paper format to electronic Common Technical Document (eCTD) submission

Without sufficient understanding on right Regulatory strategy for specific cases, many companies face delays in product registration that affect the costs. Therefore, right partner for strategic planning and monitoring Regulatory changes is the key for successful commercialization of a drug product. With a proven track record to keep abreast with global market conditions and navigating clients across through their unique Regulatory requirements, Freyr stands a preferred Regulatory strategic partner for any Pharmaceutical or Biotechnology company.