Frequently Asked Questions
Get answers to common questions about our pharmaceutical manufacturing and services
General
What is Operant Scientific Pvt. Ltd.?
What is Operant Scientific Pvt. Ltd.?
Operant Scientific Pvt. Ltd. is a leading pharmaceutical research and manufacturing company based in India with over 8 years of experience in regulatory compliance and global pharmaceutical distribution. We specialize in API manufacturing, drug development, and regulatory affairs services.
Which countries do you serve?
Which countries do you serve?
We serve over 20 countries worldwide with our pharmaceutical products and services. Our regulatory approvals include USFDA, WHO, MHRA, and Health Canada, enabling us to export to major global markets including the United States, Europe, Canada, and emerging markets.
What certifications does Operant Scientific hold?
What certifications does Operant Scientific hold?
We maintain certifications and approvals from multiple regulatory bodies including USFDA, WHO-GMP, MHRA, Health Canada, and other international pharmaceutical regulatory authorities. Our facilities are compliant with Good Manufacturing Practices (GMP) standards.
Manufacturing Services
What types of pharmaceutical products do you manufacture?
What types of pharmaceutical products do you manufacture?
We manufacture a wide range of pharmaceutical products including Active Pharmaceutical Ingredients (APIs), finished dosage forms, nutraceuticals, specialty chemicals, and surgical products. Our manufacturing capabilities cover various therapeutic categories.
Do you provide contract manufacturing services?
Do you provide contract manufacturing services?
Yes, we offer comprehensive contract manufacturing services for pharmaceutical companies worldwide. This includes formulation development, scale-up, commercial manufacturing, and packaging services under strict quality control measures.
What is your manufacturing capacity?
What is your manufacturing capacity?
Our state-of-the-art manufacturing facilities have the capacity to produce large volumes of pharmaceutical products while maintaining the highest quality standards. Specific capacity details can be discussed based on your requirements and product specifications.
Regulatory Compliance
How do you ensure regulatory compliance?
How do you ensure regulatory compliance?
We maintain a dedicated regulatory affairs team that stays updated with international pharmaceutical regulations. Our processes are designed to meet USFDA, WHO, MHRA, and Health Canada standards, with regular audits and quality assurance protocols in place.
Can you help with drug registration in different countries?
Can you help with drug registration in different countries?
Yes, our regulatory affairs team provides comprehensive drug registration services for various international markets. We assist with dossier preparation, regulatory submissions, and compliance documentation for market authorization.
What is your approach to quality control?
What is your approach to quality control?
We implement rigorous quality control measures throughout our manufacturing process, including raw material testing, in-process monitoring, finished product analysis, and stability studies. Our quality systems are compliant with international pharmacopeial standards.
Research & Development
Do you offer pharmaceutical research and development services?
Do you offer pharmaceutical research and development services?
Yes, we provide comprehensive R&D services including formulation development, analytical method development, stability studies, and process optimization. Our research capabilities support both generic and innovative pharmaceutical development.
What is your expertise in API development?
What is your expertise in API development?
We have extensive expertise in API development and manufacturing, covering various therapeutic categories. Our capabilities include process development, scale-up, and commercial production of high-quality APIs meeting international standards.
Do you conduct clinical research?
Do you conduct clinical research?
We collaborate with clinical research organizations and provide support for clinical trials, including investigational medicinal product manufacturing and supply chain management for clinical studies.
Business Partnership
How can companies partner with Operant Scientific?
How can companies partner with Operant Scientific?
Companies can partner with us through various models including contract manufacturing, licensing agreements, distribution partnerships, and joint development projects. We welcome partnerships that align with our mission of advancing global healthcare.
What are your minimum order quantities?
What are your minimum order quantities?
Minimum order quantities vary depending on the specific product and manufacturing requirements. We work with partners to establish mutually beneficial terms that ensure economic viability while meeting market demands.
Do you provide supply chain solutions?
Do you provide supply chain solutions?
Yes, we offer comprehensive supply chain solutions including procurement, manufacturing, quality control, packaging, and distribution services. Our global network ensures reliable supply chain management for international markets.
Still Have Questions?
Our team of pharmaceutical experts is here to help you with any specific inquiries