Practice Area

Pharmaceutical & Drug Laws Advisory

Overview

Expert legal consultation on Pakistan's pharmaceutical and drug regulations, ensuring compliance and protecting client interests.

Our specialized legal service focuses on all aspects of pharmaceutical and drug laws in Pakistan, offering comprehensive support to businesses, healthcare institutions, and individuals.

Key Services:

  • Regulatory compliance review for the Drug Regulatory Authority of Pakistan (DRAP)
  • Preparation and filing of drug registration dossiers and marketing authorization applications
  • Representation before regulatory authorities during inspections or audits
  • Handling enforcement actions and disputes related to drug prescribing and distribution
  • Contract drafting and negotiation for pharmaceutical manufacturing, distribution, and licensing agreements
  • Advice on labeling, packaging, and advertising compliance under the Drugs Act 1976 and subsequent amendments
  • Legal support for clinical trial protocols and ethical compliance

Frequently Asked Questions

We cover everything from drug registration and regulatory compliance to enforcement actions, contract negotiation, and representation before the Drug Regulatory Authority and other relevant bodies.

Our team assists in preparing, reviewing, and submitting complete DRAP dossiers, ensuring all technical and legal requirements are met to avoid delays or rejections.

Yes, we provide full legal representation in enforcement actions related to drug prescriptions, marketing, or distribution, defending your interests in court or administrative hearings.

We offer tailored training sessions for regulatory affairs staff, covering the Drugs Act 1976, the Pharmaceutical Act 2009, and latest amendments to keep teams up to date.

We draft and review manufacturing, distribution, licensing, and supply agreements, ensuring they comply with Pakistani drug laws and protect your business interests.