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Strategic Regulatory Partner for Success in Pakistan

Pharma Wizard Pakistan

Strategic Regulatory Partner for Success in the Market of Pakistan

The rapidly growing pharmaceutical market in Pakistan represents significant business opportunities for foreign manufacturers of medicines and medical devices. In order to capitalize on such a development, it is important to obtain necessary approvals from the Drug Regulatory Authority of Pakistan (DRAP). The DRAP is the countryā€™s regulatory body that regulates all stages of manufacturing, importing/exporting, storing, distributing, and selling medications in Pakistan.

In order to implement compliance successfully, companies should possess profound knowledge of regulatory requirements. Through the assistance of our Strategic Regulatory Partner for Success, companies will be provided with a full spectrum of regulatory services to help them become compliant in terms of regulations.

Pharma Wizard provides assistance in obtaining necessary authorizations to penetrate into the market of Pakistan and in approving medicinal drugs in Pakistan. We offer comprehensive assistance with regard to various departments of regulatory affairs, including:

DRAP registration and product licensing

Developing effective regulatory strategies

Regulatory process optimization

Market penetration speed increase

Through our reliable regulatory services, you will easily become compliant, reduce your approval time, and succeed in penetrating into the market of medicines in Pakistan. Choose the best regulatory firm in Pakistan ā€“ Pharma Wizard.

Industries We Serve in Pakistan

  • Medical Devices
  • Pharmaceuticals
  • OTC
  • Biotech

Regulatory Affairs and Support Services in Pakistan (DRAP)

Our company provides complete regulatory assistance to register, import, and commercialize pharmaceutical and life science products in Pakistan.
  • Medical Devices: Classification of products, DRAP listing/registration, label compliance, and local representative in accordance with the Medical Device Rules, 2017.
  • Biotech Products: Regulatory services for biological drugs, biosimilar and innovative products through DRAPā€™s Biological Drugs Division.
  • Local Representative Services: Full representation to foreign manufacturers looking for a regulatory representative in Pakistan.
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medical devices registration, labeling

Regulatory Services for Pharmaceutical Industries in Pakistan

Pharma Wizard Pakistan offers custom-made regulatory consulting services to pharmaceutical companies seeking entry into, establishment of operations in, or growth within the Pakistani market. Our services involve comprehensive knowledge and experience of DRAP regulations as well as compliance requirements that facilitate manufacturers’ successful approval, drug pricing and labeling, and entire product life cycle management. We tailor our services to make sure that you achieve maximum compliance, efficiency, and success in your pharmaceutical endeavors in Pakistan.
We Offer the Following Essential Regulatory Services:
  • CTD dossier preparation and DRAP registration application
  • Product registration and marketing authorization
  • Drug pricing and labeling applications and compliance
  • Approval after registration and renewal of product registration
  • Development and management of pharmacovigilance system
  • GMP compliance advisory, inspections, and audits
  • Authorized local agent and representative services
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Pharmaceuticals Regulatory Services

OTC (Over-The-Counter) Regulatory Services in Pakistan

Pharma Wizard Pakistan provides specialized OTC regulatory services to ensure strict compliance with all requirements of the DRAP in regard to over-the-counter medications. We guide our clients through product classification, registration process, labeling and packaging, and pricing approvals to help them obtain fast market access. Our experience guarantees that your OTC drugs will be in compliance with all legal requirements regarding quality and safety.
Our OTC Regulatory Services Include:
  • OTC product classification and eligibility for DRAP registration
  • Preparation of CTD dossier for over-the-counter pharmaceuticals
  • Product registration and market authorization
  • Packaging and labeling review and approval
  • Retail pricing submission and approval
  • Advertising and promotion regulatory clearance
  • Local representation services for international drug manufacturers
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EMR Transcription Services

Biotechnology Regulatory Services at Pharma Wizard Pakistan

At Pharma Wizard Pakistan, we offer custom tailored comprehensive biotechnology regulatory services that include biosimilars, innovator biologicals, vaccines, as well as other advanced therapies like cell and gene based therapy products. With an unparalleled knowledge base regarding DRAP Biological Drugs Division regulations, our company can help you meet all your regulatory needs. All our products and services are crafted to ensure timely and hassle-free product approvals in accordance with the latest biotechnology regulations in Pakistan.
These include:
  • Regulatory pathway development for biologics, biosimilars and advanced therapies
  • DRAP biological drugs CTd Dossier compilation
  • Regulatory dossier review and GMP compliance
  • Clinical data analysis and regulation alignment
  • Product registration and authorization with DRAP
  • Variation and renewals management
  • Authorized local representative for foreign biotech firms
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Medical Device Registration

Pharma Wizard Services

  • Strategic Regulatory Advisory Services
  • Regulatory Affairs and Regulatory Intelligence Services
  • Product Registration and License Management Services
  • Marketing Authorization Applications and Renewals
  • Post-Market Compliance and Vigilance Services
  • Product Variation and Change Services

Benefits of Pharma Wizard

  • Professional Regulatory Group with Extensive Global RA Experience
  • Proactive & Collaborative Approach
  • Fast Turnaround Times & Quick Time-to-Market
  • Staying Informed of Regional Specific Regulations and Guidelines
  • Over 10 Years of Experience with Regulatory Affairs in Pakistan
  • Local DRAP Representative

Looking for Regulatory Assistance in Pakistan

Contact us now for Expert Guidance and Support

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Frequently Asked Question

DRAP (Drug Regulatory Authority of Pakistan) is an established regulatory body that oversees pharmaceutical drugs, biologics, medical devices, and healthcare products. The product registration process in Pakistan requires DRAP approval to legally sell regulated products in the country.
Foreign manufacturers need to register themselves under DRAP regulations, select their authorized representative if necessary, and proceed further with product registration/enrollment.
Regulatory strategy formulation, product registration, licensing, regulatory intelligence, authorization of market access, post-market compliance, product variation and renewal, as well as local representation for Pakistan, are some of the services offered by Pharma Wizard.
The duration of product registration will depend on the type of product, availability of information, regulatory requirements, and DRAP’s procedures for registration.
Yes. Pharma Wizard assists with the regulatory affairs of medical devices, prescription and over-the-counter pharmaceuticals, biosimilars, biologics, and other products in the healthcare sector.