FMCG and Pharmaceutical Industry needs special attention considering specific laws applicable to such industry. Our team navigates the tricky pharma regulatory environment with clear and concise advice. We help with compliance on regulatory and policy issues, ethics, data exclusivity and protection, labeling, and legal metrology.
- Advisory on compliance with statutory requirements and conditions of license
- Advisory on the import of approved or unapproved products and product registration
- Advisory on manufacture, laboratory testing, and quality standards
- Advisory on online sales and e-pharmacy, good distribution, recalls, and alert
- Advisory on price control, over-charging, price ceiling
- Advisory on ethical and legal promotion, patient testimonials, HCP- industry interaction for training
- Advisory on cross-border product liability claims against manufacturers.
- Undertaking legal due diligence on business models, processes, compliance status
- Drafting investment agreements (SHAs, SPAs, Debenture Deeds)
- Dispute resolution by arbitration and litigation for enforcement of commercial rights for breach of contractual obligation
- Drafting transactional documents for contract manufacture, loan license
- Drafting a clinical trial agreement
- Advisory on structuring the business to reduce legal liability on account of defective products or deficient services
- Drafting of limitation of liability, disclaimer, and product warranties