EXCLUSIVE FEATURES FOR YOU

Orphan Drug / Rare Diseases

• Medical Writing: From technical documentation to strategic program evaluation, our team delivers high-quality medical writing services to support your regulatory submissions and engagements.

• Evaluation of IND/NDA Gaps: We conduct thorough evaluations of Investigational New Drug (IND) and New Drug Application (NDA) gaps while maintaining strict confidentiality.

• Preparation and Submission of IND/CTA: We assist in preparing and submitting IND/CTA applications for regulatory approval in key regions including the USA, EU, AU, and CA.

• Development of Meeting Packages: We prepare comprehensive meeting packages for engagements with regulatory authorities such as the FDA and EMA, ensuring effective communication and alignment of strategies.

• Creation of Investigator's Brochures: Our team crafts Investigator's Brochures to provide essential information about the investigational product to clinical investigators.

• Orphan Drug Designation Applications: We facilitate the submission and management of Orphan Drug Designation applications with regulatory agencies, helping to secure valuable incentives for orphan drug development.

• Rare Pediatric Disease Designations: We assist in the preparation and submission of applications for Rare Pediatric Disease Designations, which can lead to the coveted Priority Review Voucher (PRV).

• Fast Track Designations: We support companies in obtaining Fast Track Designations for their products, expediting the development and review process

Medical Devices

• Regulatory Strategy Development: We work closely with your team to develop regulatory strategies that align with your product development goals and target markets.

• Preparation of Regulatory Submissions: From 510(k) submissions to premarket approval (PMA) applications, we assist in the preparation and submission of regulatory documents to the FDA and other regulatory authorities worldwide.

• Quality Management System (QMS) Consulting: We provide expert guidance on establishing and maintaining compliant quality management systems to ensure regulatory compliance and product quality.

• Technical File/Design Dossier Preparation: Our team helps prepare technical documentation, including design dossiers and technical files, to support CE Marking and other international regulatory submissions.

• Risk Management: We assist in developing comprehensive risk management plans and conducting risk assessments to ensure the safety and effectiveness of your medical devices.

• Post-Market Compliance: We provide support in post-market surveillance, adverse event reporting, and compliance with post-market regulatory requirements to maintain product safety and efficacy.

• Labeling and Packaging Compliance: We offer guidance on labeling and packaging requirements to ensure compliance with regulatory standards and enhance product marketability.

• Regulatory Training and Education: We provide customized training programs and educational workshops to equip your team with the knowledge and skills necessary for regulatory compliance and success.