Regulatory Information
AllmaxLabs operates under the strictest pharmaceutical regulatory frameworks to ensure safety, efficacy, and quality in every product we manufacture.
Health Canada Licensing
AllmaxLabs Pharmaceutical holds an active Establishment Licence issued by Health Canada under the Food and Drugs Act and its associated regulations. Our licence covers the manufacture, packaging, labelling, and distribution of pharmaceutical drugs for human use. All product distributed in Canada carry a valid Drug Identification Number (DIN) or Natural Product Number (NPN) as appropriate.
Good Manufacturing Practices (GMP)
Our facilities operate in full compliance with Division 2, Part C of the Food and Drug Regulations (Canada) and the WHO Good Manufacturing Practices guidelines. Annual internal audits and periodic third-party inspections ensure continuous compliance. Key GMP controls include:
- Validated manufacturing processes and equipment qualification.
- Strict environmental monitoring of cleanroom facilities.
- Full Chain of Custody documentation for all raw materials and APIs.
- Robust Change Control, Deviation, and CAPA management systems.
- Sterility assurance programs for all injectable and parenteral products.
Product Safety & Pharmacovigilance
AllmaxLabs maintains an active Pharmacovigilance System to monitor the safety of all marketed products. We comply with Health Canada's Marketed Health product Directorate (MHPD) requirements for adverse drug reaction reporting. Healthcare professionals and patients can report adverse events through our medical affairs team or directly to Health Canada's MedEffect Canada programme.
Medical Affairs / Pharmacovigilance:
Email: info@allmaxlabs.com
Phone: +1 (800) 255-6629
Product Verification & Anti-Counterfeiting
Every AllmaxLabs product carries a unique, tamper-evident verification code. Patients, pharmacists, and healthcare providers can verify product authenticity instantly using our Product Verification Tool. Our serialisation programme complies with Track & Trace requirements as outlined by Health Canada's Drug Supply Chain Integrity Initiative.
Recalls & Market Withdrawals
In the event of a voluntary or Health Canada-directed recall, AllmaxLabs follows our Product Recall Standard Operating Procedure and communicates promptly with distributors, healthcare providers, and the public. All active and historical recall information is filed with Health Canada's recalls database.
For recall-related queries, contact our Quality Assurance department at info@allmaxlabs.com.
Environmental & Sustainability Compliance
AllmaxLabs adheres to all applicable provincial and federal environmental regulations governing pharmaceutical manufacturing in Canada, including proper disposal of pharmaceutical waste and solvent recovery in compliance with the Canadian Environmental Protection Act (CEPA). We are committed to progressive reduction of our environmental footprint across all manufacturing operations.
Regulatory Affairs Contact
For regulatory submissions, product dossier inquiries, or licensing questions:
AllmaxLabs Pharmaceutical — Regulatory Affairs
Email: info@allmaxlabs.com
Phone: +1 (800) 255-6629
14 Pharma Industrial Park, Science City, CA 90210, USA