We handle the entire process of marketing authorizations for various products, including human and veterinary medicines, medical devices, nutritional supplements, foods, and cosmetics. This ensures your products meet regulatory requirements and are approved for distribution in a given locality.
Regulations pertaining to pharmaceutical products are continuously changing and creating challenges for global pharmaceutical industry. This affects the regional and global regulatory requirements for product approval.
We assist manufacturers in obtaining Good Manufacturing Practice (GMP) and Quality Audit approvals through inspections and evaluations. Our comprehensive approach includes detailed assessments and actionable recommendations to enhance compliance and process efficiency.
Our team monitors and manages the safety of pharmaceuticals post-market, ensuring patient safety and regulatory compliance. This involves detecting, assessing, and preventing adverse effects through rigorous monitoring and timely interventions. Our pharmacovigilance services enhance patient trust and safety, maintain compliance, and provide crucial insights for product improvement.
We provide local representation to assist with regulatory compliance, acting as a liaison between regulatory authorities and your company. This service ensures smooth communication and adherence to local regulations, making the regulatory process more manageable and efficient for you.
Our market research services involve conducting detailed analyses of the regulatory landscape and market conditions. This helps guide your regulatory strategies and ensures that your products are positioned effectively in the market.
We offer customized training programs designed to keep your team updated on the latest regulatory standards and practices. This ensures your staff are well-equipped to handle regulatory challenges and maintain compliance
Ensuring facilities comply with regulatory standards is crucial for maintaining product quality and safety. We will ensure your facilities meet regulatory standards through thorough validation and registration processes.
Regulatory issues arise unexpectedly and can create significant strain on a company’s resources. As such, it is advisable for all companies to carry out regular and frequent regulatory due diligence and regulatory audits.
Securing these approvals is essential for the legal and seamless movement of pharmaceutical products across borders. We will help you obtain the necessary permits for importing and exporting your pharmaceutical products, ensuring compliance with international and local regulations.
Navigating global pharmaceutical regulations is essential for bringing safe, effective products to the market efficiently. Our comprehensive regulatory affairs services support every stage of the product lifecycle-from market research, eCTD submission to post marketing surveillance.
