,
Greetings from
Freyr Pakistan
With a developing Pharmaceutical market that boasts a good fortune for foreign medicinal product and medical device manufacturers, Pakistan attracts significant investments in the region. To access the market, manufactures must obtain approvals from the Drug Regulatory Authority of Pakistan (DRAP), a regional health authority that regulates the manufacture, import, export, storage, distribution and sale of therapeutic goods. However, manufacturers must possess an expert hold of Regulatory affairs in the region to navigate the market for product market authorizations and drug approvals.
Aiming at redefining the Regulatory solutions and services globally with a specialized regional focus, Freyr assists manufacturers with the needed Regulatory consulting support in Pakistan and extends value-added Regulatory operations and Regulatory affairs support in the region. Freyr’s Regulatory Services in Pakistan span across:
- Medical Devices
- Pharmaceuticals
- OTC
- Biotech
Industries We Serve in Pakistan
The Drug Regulatory Authority of Pakistan (DRAP), under the Ministry of National Health Services, Regulations and Coordination (MoNHSR&C), oversees the regulation of pharmaceutical products to ensure their safety, efficacy, and quality. Registration under the Drug Act, 1976 and DRAP Act, 2012 is mandatory before local marketing or import. Key challenges include dossier harmonization with CTD format, GMP certification, and alignment with pricing and labeling requirements.
Freyr Solutions provides comprehensive Regulatory support in Pakistan — from dossier preparation and GMP documentation to pricing strategy, variation management, and health authority liaison — ensuring compliant and accelerated market entry.
To be sold in Pakistan, all medical devices must first be registered with the Drug Regulatory Authority of Pakistan (DRAP). DRAP protects patients by ensuring that devices fulfil quality standards, encourage public trust, and drive innovation with a clear path for safe and new technology. Discover how Freyr's medical device Regulatory experts can streamline your Pakistan medical device consulting needs with comprehensive end-to-end services.
Freyr Offerings
- Strategic Regulatory Consulting
- Regulatory Affairs & Regulatory intelligence,
- Registration pathways and license management services,
- Marketing authorization applications, renewals
Freyr Advantages
- Expert Regulatory team with proven global RA expertise
- Proactive and Collaborative approach
- Quick turnarounds and faster time-to-market
- Keeping abreast with region-specific legislation and Regulatory guidelines