Growing a pharma business requires a strategic approach considering the specific context of your company and the pharmaceutical industry as a whole. Here are some general pointers to get you started: Market and Customer: Identify your target customer: Deeply understand the specific needs and challenges of your target audience, whether it's doctors, patients, hospitals, or other healthcare providers. This helps tailor your products, services, and marketing efforts. Focus on unmet needs: Look for gaps in the market where existing solutions are inadequate or unavailable. Addressing unmet needs can give you a competitive edge and drive innovation. Track market trends: Stay updated on regulatory changes, technological advancements, and emerging diseases to adapt your approach and anticipate future opportunities. Products and Services: Invest in R&D: Develop innovative products or differentiate existing ones through unique formulations, delivery methods, or combinations. Remember
Schedules: Schedule A, Schedule B, Schedule C, Schedule D, Schedule E1, Schedule F, Schedule G, Schedule H, Schedule H1, Schedule I, Schedule J, Schedule K, Schedule L1, Schedule M, Schedule M1, Schedule M2, Schedule M3, Schedule N, Schedule O, Schedule P, Schedule Q, Schedule R, Schedule S, Schedule T, Schedule U, Schedule V, Schedule W, Schedule X, Schedule Y
Schedule L (Omitted)
Schedule L-1 (Rule 74,78 and 150E):
Schedule L and Schedule L1:
Schedule L (Omitted)
Schedule L-1 (Rule 74,78 and 150E):
Schedule L describes the good laboratory practices and requirements of premises and equipments.
- General Requirements
- Premises
- Personnel
- Equipments
- Chemical and Reagents
- Good Housekeeping and Safety
- Maintenance, calibration, and validation of equipments
- Reference materials
- Microbiological Cultures
- Quality System
- Internal Quality system audit
- Management Review
- Standard Operating Procedures
- Protocols and specifications archive
- Raw Data
- Storage and archival
For more detail refer Drug and Cosmetic Act
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