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License Set Up Services For
WDA, MIA, PLPI, MS and Controlled Drugs 
in UK, EU and USA

Wholesale Distribution Authorisation
(WDA) for human & Veterinary Products & API

Secure Your Wholesale Distribution Authorisation with PharmaGXP

Achieving Wholesale Distribution Authorisation (WDA) is crucial for companies involved in the wholesale of human and veterinary products and Active Pharmaceutical Ingredients (APIs). This certification, governed by regulatory standards, ensures that companies comply with safety and quality measures for distributing pharmaceutical products in the market.

PharmaGXP is your trusted partner in acquiring a WDA. Our expert services include:

  • Regulatory Compliance: We ensure your operations adhere to the stringent standards required for WDA, safeguarding product integrity from procurement to distribution.

  • Documentation and Procedures: Our team assists in developing and maintaining comprehensive documentation and SOPs essential for WDA approval.

  • Application and Process Management: We handle the entire application process, from initial documentation to final submission, ensuring a seamless and efficient pathway to obtaining your license.

Partner with PharmaGXP to facilitate your WDA application and maintain the highest standards of pharmaceutical distribution.

 

Reach out today to learn how we can assist your business.

Manufacturing
Import
Authorisation
(MIA)

Achieve Compliance with an MIA License through PharmaGXP

The Manufacturer/Importer Authorization (MIA) license is a mandatory license for companies want to manufacture and import of medicinal products from non-EU countries and for products manufactured in EU countries but released in the UK. This license confirms that your operations comply with Good Manufacturing Practices (GMP), ensuring that your products are consistently high in quality and safe for consumer use.

Why is an MIA License Required?

  • Regulatory Compliance: Ensures your manufacturing and importation processes meet stringent regulatory standards.

  • Market Access: Enables legal entry into the market, essential for commercial distribution.

  • Quality Assurance: Maintains high standards of product quality and safety.

How PharmaGXP Can Help:

  • Expert Guidance: PharmaGXP provides expert consultancy on GMP compliance, helping you understand and implement the necessary regulations.

  • Documentation Preparation: We assist in the meticulous preparation of all required documentation, ensuring accuracy and completeness for a smooth approval process.

  • Streamlined Application Process: Our team handles every aspect of the MIA application, from initial consultation to liaising with regulatory bodies, simplifying the process and saving you time.

Partner with PharmaGXP to secure your MIA license efficiently, ensuring your business operates legally and meets the highest standards of quality and safety.

 

Contact us today to get started.

Parallel Import
Product License
(PLPI) 

Navigate Parallel Import Licensing with PharmaGXP

The Parallel Import Product License (PLPI) is essential for businesses looking to legally import and resell pharmaceutical products that are already authorized and marketed in another country. This license is crucial as it ensures that parallel imported products meet the same standards of safety, quality, and efficacy as those initially approved.

Why is a PLPI License Required?

  • Cost Efficiency: Enables access to lower-priced pharmaceuticals from different markets, offering cost benefits to both importers and consumers.

  • Regulatory Compliance: Ensures that all imported pharmaceuticals comply with local safety and efficacy standards.

  • Market Access: Allows companies to legally introduce and distribute parallel-imported products in the market.

How PharmaGXP Can Assist in Acquiring a PLPI License:

  • Regulatory Expertise: PharmaGXP offers in-depth knowledge of the regulatory requirements and processes involved in obtaining a PLPI license.

  • Application Support: We guide you through the entire application process, from documentation preparation to submission, ensuring all criteria are met efficiently.

  • Strategic Planning: Our team provides strategic advice to optimize your product sourcing and maximize the economic benefits of parallel importing.

PharmaGXP is here to streamline your path to obtaining a PLPI license, enabling your business to expand its product offerings and leverage market opportunities effectively.

 

Contact us today to find out how we can support your licensing needs.

Manufacturer's
Special (MS)
License for
Unlicensed 
Medicine
Import 

Obtain Your Manufacturer Specials Import License with PharmaGXP

Navigating the complexities of the MHRA's Manufacturer Specials Import License can be challenging. This essential license permits the importation and distribution of unlicensed medicines within the UK, catering specifically to patient needs when licensed alternatives are unavailable.

 

At PharmaGXP, we specialize in guiding pharmaceutical companies through the intricate process of obtaining this license. Our services include:

  • Compliance Guidance: We ensure your manufacturing and documentation practices meet MHRA standards.

  • Application Assistance: Our team expertly handles the preparation and submission of your application, ensuring a smooth and compliant process.

  • Regulatory Expertise: We offer in-depth advice on regulatory requirements, helping you navigate the approval process with ease.

Let PharmaGXP help you expand your ability to meet unique patient needs with the Manufacturer Specials Import License.

 

Contact us today to get started.

Controlled Drug License from
Home Office

Secure Your Home Office Controlled Drug License with PharmaGXP

The Home Office Controlled Drug License is a critical requirement for businesses handling, storing, or distributing controlled substances. This license ensures that companies operate within the strict legal frameworks designed to prevent misuse while ensuring that these substances are available for legitimate medical, scientific, and research purposes.

Why is a Controlled Drug License Required?

  • Regulatory Compliance: Adheres to stringent regulations set by the Home Office to manage controlled substances responsibly.

  • Operational Legality: Enables lawful handling and distribution of controlled drugs, essential for operations in the pharmaceutical and healthcare sectors.

  • Safety and Security: Maintains high standards of security and control measures to prevent unauthorized access and misuse.

How PharmaGXP Can Assist in Acquiring a Controlled Drug License:

  • Comprehensive Guidance: PharmaGXP provides expert advice on the specific regulatory requirements for handling controlled substances, ensuring your business complies with all legal obligations.

  • Documentation and Application Support: Our team assists in preparing and submitting all necessary documentation, ensuring completeness and accuracy to facilitate a smooth licensing process.

  • Ongoing Compliance Support: Beyond obtaining the license, PharmaGXP offers continued support to ensure that your operations remain compliant with evolving regulations.

PharmaGXP is dedicated to helping your business navigate the complexities of obtaining and maintaining a Home Office Controlled Drug License. Let us help you ensure that your operations are both compliant and efficient.

 

Contact us today to learn how we can assist you in securing your license and supporting your business’s growth.

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