Pharmaceuticals:
Drug Approvals and Licensing:
Role: Legal experts in this field assist pharmaceutical companies in obtaining regulatory approvals and licenses for the sale and distribution of drugs. This involves navigating the complex approval processes with regulatory agencies like the Central Drugs Standard Control Organization (CDSCO) in India.
Expertise: Globe Law & Co LLP experts are well-versed in the laws and regulations governing pharmaceutical approvals, ensuring that drugs meet safety and efficacy standards before they reach the market.
Patents and Intellectual Property:
Role: Lawyers specializing in pharmaceuticals protect the intellectual property of pharmaceutical companies, including patents for new drugs and formulations. They also handle disputes related to patent infringement and generic drug challenges.
Expertise: Their expertise includes patent prosecution, patent litigation, and strategies to extend the exclusivity of pharmaceutical products.
Regulatory Compliance:
Role: Regulatory compliance attorneys ensure that pharmaceutical companies adhere to laws and regulations governing drug manufacturing, labeling, and marketing. Compliance with the Drugs and Cosmetics Act, 1940, in India is paramount.
Expertise: They provide guidance on Good Manufacturing Practices (GMP), quality control, labeling requirements, and pharmacovigilance, among other regulatory aspects.
Pricing and Market Access:
Role: Attorneys in this area help pharmaceutical companies navigate pricing regulations and market access policies. They provide counsel on drug pricing strategies, negotiations with government authorities, and reimbursement mechanisms.
Expertise: They understand the intricacies of health economics, market access, and pricing negotiations to ensure that pharmaceutical products are accessible and affordable to patients.
Vishal Punwani
Partner
Advocate High Court
vishalpunwani@globelawfirm.com
+91-8369262393 | +91-9967546605
Noshir Fali Kumana
Senior Associate
Advocate & Solicitor
Educational Qualifications
B.Sc., LL.B., Solicitor, Diploma in Business Management (IMC)