We specialize in regulatory consultation for pharmaceutical drugs, cosmetics, over-the-counter (OTC) products, and natural health products (NHPs) in Canada and the USA.
We deliver export documents such as Certificates of Free Sale and Country of Origin certificates at about one quarter of the typical industry cost and turnaround time, achieved through optimized processes and direct familiarity with regulatory authorities.
Yes, we offer MoCRA registration services including preparation and submission to help cosmetic brands comply with the latest US MoCRA requirements.
We prepare and maintain GHS-compliant Safety Data Sheets, ensuring they meet current standards and are regularly updated to reflect regulatory changes or formulation updates.
Our services are primarily delivered through remote consultations and digital document exchange, with face-to-face meetings available only when necessary.
We provide comprehensive dossier compilation, document preparation, and submission process guidance for new drug applications in both Canada and the USA.
Our clients include pharmaceutical manufacturers, cosmetic brands, contract manufacturers, OTC and natural health product companies, and exporters targeting Canadian and US markets.
We offer professional labeling and claims consultation to ensure all product materials meet Health Canada, FDA, and other applicable regulatory standards.
Our export documentation services typically complete in about one quarter of the usual industry turnaround time, enabling faster customs clearance and shipment releases.
Yes, we provide ongoing support to help clients maintain compliance with regulatory requirements after drug product approval.
We liaise with trusted third-party laboratories to arrange analytical, safety, and performance testing required for regulatory submissions, managing scheduling and communication on behalf of clients.
Clients can pay securely through our integrated website payment section using standard debit and credit cards.
Yes, we provide a free initial consultation to discuss client needs and outline how our services can assist with regulatory compliance and submissions.
Our expertise covers both Health Canada and FDA frameworks, allowing us to guide clients through distinct requirements and submission pathways for each market.
Yes, we assist clients in selecting the correct product category, compiling supporting data, and meeting specific regulatory requirements for OTC drugs and natural health products.