Pharmaceutical, Medical Devices , and Cosmeceuticals Regulatory Services
- Pharmaceutical, Medical Device, Cosmeceuticals Product Approval and Registration Support: Providing guidance and support throughout the product approval, registration process and renewal, including compiling and submitting regulatory dossiers to health authorities.
- Regulatory Submissions Management: Managing and coordinating all aspects of regulatory submissions to health authorities, including Investigational New Product Applications and New Product Applications.
- Post-Marketing Regulatory Affairs: Assisting with post-approval regulatory activities, such as variations, renewals, and updates to approved drug, medical device & Cosmeceuticals applications.
- Labeling and Packaging Compliance: Helping pharmaceutical, Medical Device, and Cosmeceuticals companies create and review product labeling and packaging materials to ensure compliance with regulatory requirements.
- Regulatory Training and Workshops: Conducting training sessions and workshops for pharmaceutical, Medical Device and Cosmeceuticals company staff to enhance their understanding of regulatory processes and compliance.
- Regulatory Intelligence: Monitoring and providing updates on changes in pharmaceutical, Medical Device and Cosmeceuticals regulations, guidelines, and requirements to keep clients informed and compliant.
- Regulatory Advocacy: Representing clients and advocating for their interests in interactions with regulatory authorities.
Our objective is to listen and understand YOUR business needs in order to provide YOU with the right regulatory solutions