We offer Good Manufacturing Practices (GMP) training and facility GMP certification for all frontline employees in the pharmaceutical industry, by FDA and World Health Organization (WHO) guidelines. Obtaining WHO GMP Certification makes your company globally accredited, as it is the most rigorous GMP certification to attain. 

.We go the extra mile with regulatory requirements. GMP training and certification help protect your products from contamination and adulteration. To help meet these training needs, US-Bachem offers a comprehensive array of GMP training, guiding your facility through the proper documents to submit. We conduct virtual facility inspections with travel savings applied to your program. Our program guarantees your facility or institution will be WHO GMP certified in 6 weeks.

We offer comprehensive pharmaceutical training courses for manufacturing solid dosage products, as well as tablet processing training classes. One-on-one individualized training classes for pharmaceutical interns, businesses, and industries. A two-day hands-on training on these topics

• Tablet Compression Principles, Tooling Inspection, API, and Excipient
• Tablet Press Set-Up Assembly and Disassembly, Operation, and Cleaning 
• Wet Granulation, Dry Granulation, and Direct Compression
• Troubleshooting, Solving Common Defects, Monitoring Tableting Process
• Parameters of Weight, Thickness, Hardness, Friability, and Disintegration

 Solid Dosage Manufacturing Process Training, Tableting, Encapsulation, Film Coating Technologies, and Granulation Technologies

A comprehensive solid dose training course for beginners and experts, imparting essential principles and concepts while enabling participants to understand equipment, processes, and powder manipulation techniques for tablet and capsule production across any facility. The program also provides hands-on experience, ensuring a well-rounded understanding of both theoretical and practical aspects of solid dose manufacturing.

In-Person Pharmaceutical Manufacturing Training Courses in the Lab at US-Bachemistry

US-Bachem offers a one-of-a-kind classroom lab experience, showcasing world-class pharmaceutical equipment in use at our pilot plant lab. Attendees participate in live demonstrations of manufacturing principles, enhancing their understanding of essential processes. Our hands-on approach extends beyond theoretical concepts, offering a unique opportunity not only to observe but also to operate real pharmaceutical production machines, thereby fostering a practical understanding of the processes involved.

Customized On-Site Pharmaceutical Manufacturing Training Courses at Your Facility

US-Bachem brings expert-led pharmaceutical manufacturing education directly to your facility, tailoring courses to your team's specific needs and equipment. Our experienced instructors combine theoretical knowledge with hands-on demonstrations, utilizing your in-house machinery and practices for a comprehensive learning experience. Training at your facility fosters greater team collaboration in a familiar and convenient setting.

 FDA Product Registration and Consulting Services 

Our products are currently marketed in Europe, the United States, Canada, South Africa, Brazil, and the Middle East. We provide private label distributors with documents for their country's legal registration of our products as Over-the-counter medications without a prescription.

The product registration documents required by most countries are:

• Product certificate of analysis,
• Ingredients certificate of analysis,
• Certificate of free sale,
• Certificate of origin,
• Our company`s state license 
• FDA facility registration documents,
• Product NDC number as OTC with the FDA,
• Product Stability test reports,
• Product Microbiology test
• Batch production records.
• Product purchase order paid invoices.

For OTC tablets (oral solid dosage) additional test reports required are:

• Tablet friability test,
• Tablet disintegration test report,
• Tablet dissolution test,
• Tablet moisture test report,
• And shelf-life reports

US-Bachemistry FDA Over the Counter (OTC) Drug Approval Consulting Services

Over-the-counter (OTC) drug products are defined as drugs that do not require a medical prescription. They are safe and effective for use without the need for treatment from a healthcare provider. The FDA reviews the active ingredients and labeling of these OTC drug. There are over 300,000 OTC drug products marketed in the United States. The FDA conducts a regulatory review based on the active pharmaceutical ingredient and labeling by therapeutic class, rather than evaluating individual drug formulations.

Firms intending to market a new product or OTC drug must submit an NDA (505) (b)(1) or 505(b)(2) application. Meeting FDA requirements can be a long process in most cases. An experienced staff can assist you with the complicated process of submission, compliance, and filing.

The two regulatory pathways for OTC drug in the United States are firstly, development under the OTC monograph process: or secondly, through the New Drug Application (NDA) process. Products that do not meet the conditions of the OTC drug monograph must seek approval through the NDA process.

Our services as an FDA Over the Counter Drug Approval Consultant include:

• Drug classification.
• Labeling assistance
• OTC drug monograph applications
• Prescription to OTC switch applications
• Preparation of Time and Extent Application (TEA) for OTC Drug Monograph amendment
• Assistance to meet post-approval requirements.
• US Agent

Our in-house consultants work with you through all the phases of the process and ensure timely approval and marketing of your OTC product. Our compliance department is well-experienced in regulatory strategies to ensure prompt and efficient FDA compliance throughout all phases of the approval process. We have over two decades of experience in assisting firms with the FDA approval pathway for OTC drugs.

Our consultants have an in-depth understanding of FDA regulations and can determine the appropriate drug classification (monograph or ANDA) and also help prepare compliant labels according to the OTC drug monograph. What’s more, our consulting services are quicker and more cost-efficient than other firms in this domain.