Regulatory

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.

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Pharma

  • Bio-pharma
  • Specialty Products
  • Formulations
  • API & Intermediates
  • Narcotic and Psychotropic Substances
  • Research, Development & Testing
  • Pharmacovigilance

Medical Device

  • Med-tech
  • Implants
  • Wearables
  • Equipment
  • Disposables
  • Materiovigilance

Hospitals & Nursing Homes

  • Hospitals & Nursing Homes
  • Home-care
  • Biomedical waste disposal
  • Privacy & Data Protection
  • Electronic Health Records

Diagnostics

  • Reagents
  • Diagnostic equipments
  • Pathalogy Labs
  • Precision Diagnostics

Food & Beverages

  • Packaged Food
  • Packaged Beverages
  • Alcohols & Spirits
  • Health Supplements
  • Nutraceuticals
  • Genetically Modified Food
  • Organic Food

Cosmetics

  • Haircare
  • Skincare
  • Oral care
  • Fragrances
  • Cosmoceuticals

Clinical Trials

  • Clinical Trials
  • BA/BE studies
  • Animal Trials
  • CROs
  • SMOs
  • Post Marketing Surveillance

Emerging Technology

  • e-Consultations
  • e-Pharmacy
  • Drones
  • Artificial Intelligence
  • Block-chain
  • Patient Registry for
  • Implants

Insurance

  • Get insured
  • Get insurance coverage
  • for product

Medical Practitioners

  • Doctors
  • Dentists
  • Pharmacists

Classical Medicines

  • Ayurveda
  • Homeopathy
  • Naturopathy
  • Ayurceuticals

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