Regulatory Pathway Selection: Identifying the most efficient and cost-effective regulatory pathway for a product, considering factors such as development stage, target markets, and regulatory requirements.
Regulatory Strategy Development: Creating a comprehensive regulatory strategy that aligns with the overall product development plan and business objectives.
Guideline Development and Writing: Collaborating with authorities to draft clear, concise, and scientifically sound guidelines.
Ensuring alignment with international standards while considering country-specific needs and contexts.
Dossier Preparation: Developing high-quality regulatory dossiers, including Product Approval Applications, Product Classification Applications, Manufacturer Registration Applications, and Product Registration Applications.
Technical Writing: Preparing clear and concise regulatory documents, such as protocols, reports, and summaries of safety information.
Regulatory Submission Management: Managing the submission process, including electronic submissions, paper submissions, and interactions with regulatory authorities.
Regulatory Compliance Monitoring: Ensuring ongoing compliance with regulatory requirements, including but not limited to Good Manufacturing Practices (GMP) and Good Pharmacovigilance Practices (GPVP).
Regulatory Surveillance: Monitoring product safety and efficacy after market authorization.
Regulatory Due Diligence: Assessing the regulatory status of products and companies during mergers, acquisitions, and licensing deals.
Providing Training: Offering training on regulatory requirements and best practices to internal and external stakeholders.
