In relation to drugs, medical devices, food, beverages and cosmetics we provide the following servces:
- Advisory on compliance with statutory requirements and conditions of license.
- Advisory on import of approved or unapproved product, import for personal-use, import under compassionate use, product registration, marketing approval, customs clearance.
- Advisory on export, re-export of defective product to country of origin, organic food registration, plant quarantine, customs clearance.
- Advisory on clinical trials, animal trials, clinical research, research and development, compensation for patients due to trial related injury or death, HCP disclosures, tracing of lost to follow-up patients.
- Advisory on manufacture, manufacture for test purposes, laboratory testing, good manufacturing practices, quality standards.
- Advisory on sale, online sale, e-pharmacy, good distribution practices, recalls and alerts Advisory on price control, over-charging, price ceiling, price-increase.
- Advisory on product labelling.
- Advisory on ethical and legal promotion and marketing, advertising, patient testimonials, HCP- industry interaction for training.
- Handing regulatory show cause notices, warning notices, inspections, inspection reports.
In relation to health care we provide the following services:
- Advisory on compliance requirements to offer healthcare services of any kind in India, including modern medicine, alternative medicine, physiotherapy, psychotherapy.
- Advisory on tele-consultation, tele-medicine, tele-radiology, second opinion.
- Advisory on cross-border medical consultation, medical tourism.
- Advisory on mobile healthcare, home ICU, remote healthcare.
- Advisory on possession and use of narcotic drugs and psychotropic substances.
- Advisory on electronic health standards and personal data privacy and protection.
- Advisory on risk mitigation strategies to reduce exposure from medico-legal liability.