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Pharma 4U is your trusted partner for comprehensive pharmaceutical consulting services.
Our team is dedicated to helping you navigate the complex landscape of regulatory requirements and quality assurance, ensuring compliance and fostering excellence in every aspect of your operations.
Licensing & Registrations
- Drug Establishment License
- Medical Device Establishment License
- Natural Health Product Registration
- Drug Identification Number
- Controlled Drugs and Substances
- Food and Drug Administration
- ISO Registrations
Documentation
- Standard Operating Procedures (SOPs)
- Qualification and Validation (IQ/OQ/PQ)
- GMP Training
- Annual Product Quality Review
- Deviations and CAPA
- Product Specifications
- Batch Record Review
GMP Audits
Licensing & Registrations
Obtain essential licenses and registrations, including Drug Establishment License, Medical Device Establishment License, Drug Identification Number, Controlled Drugs and Substances permits, FDA approvals and ISO Registrations.
- Drug Establishment License: Ensure compliance with regulatory requirements for pharmaceutical manufacturing facilities.
- Medical Device Establishment License: Secure authorization for the production and distribution of medical devices.
- Drug Identification Number: Obtain official recognition for pharmaceutical products within regulatory frameworks.
- Controlled Drugs and Substances permits: Navigate the regulations governing the production and distribution of controlled drugs and substances.
- Food and Drug Administration approvals: Gain approval from the FDA for pharmaceutical products and processes.
- ISO Registrations: Achieve ISO certifications to demonstrate adherence to international quality standards.
Documentation
Develop and maintain crucial documentation, such as Standard Operating Procedures (SOPs), Qualification and Validation protocols (IQ/OQ/PQ), GMP Training materials, Raw materials and finished product testing procedures, Annual Product Quality Review documentation, Deviations and Corrective and Preventive Action (CAPA) plans, and Product Release specifications.
- Standard Operating Procedures (SOPs): Establish standardized protocols for manufacturing and quality control processes.
- Qualification and Validation protocols (IQ/OQ/PQ): Ensure the qualification and validation of equipment and processes.
- GMP Training materials: Provide comprehensive training materials to ensure compliance with Good Manufacturing Practices.
- Raw materials and finished product testing procedures: Establish protocols for testing the quality of raw materials and finished products.
- Temperature Mapping reports: Assess and document temperature variations.
- Annual Product Quality Review documentation: Conduct regular reviews of product quality to maintain high standards.
- Deviations and Corrective and Preventive Action (CAPA) plans: Address and rectify deviations from established processes to prevent recurrence.
- Product Release specifications: Define criteria for releasing products for distribution based on quality assurance standards.
- Specifications
GMP Audits
Ensure regulatory compliance through rigorous GMP Audits, including Compliance Audits, Vendor and Supplier Audits, comprehensive Documentation reviews, and thorough Self Inspections to identify areas for improvement and ensure adherence to industry standards.
- Compliance Audits: Evaluate adherence to regulatory requirements and industry standards.
- Vendor and Supplier Audits: Assess the quality and compliance of vendors and suppliers.
- Documentation reviews: Review documentation to ensure accuracy, completeness, and compliance.
- Self Inspections to identify areas for improvement and ensure adherence to industry standards.
At Pharma 4U, we understand the critical importance of regulatory compliance and quality assurance in the pharmaceutical industry. With our expert consulting services, you can trust that your operations are in capable hands. Contact us today to learn more about how we can support your success.