License Set Up Services For WDA, MIA, PLPI, MS and Controlled Drugs in UK, EU and USA
WDA License
Achieving a Wholesale Distribution Authorisation (WDA) is essential for companies involved in the wholesale of human and veterinary products, including Active Pharmaceutical Ingredients (APIs). WDA certification ensures compliance with stringent safety and quality standards for the distribution of pharmaceutical products.
How PharmaGXP Helps:
License Set Up Services For WDA, MIA, PLPI, MS and Controlled Drugs in UK, EU and USA
- Regulatory Compliance: We ensure your operations adhere to all required regulatory standards for WDA.
- Documentation & SOP Development: We assist in the creation and maintenance of necessary documentation.
- Application & Process Management: From initial documentation to final submission, we handle the entire process for a seamless experience.
Why is a WDA License Important?
A Wholesale Distribution Authorisation (WDA) ensures that your company is legally authorized to distribute pharmaceutical products, including human and veterinary medicines, as well as APIs. This license is essential for compliance with regulatory standards that safeguard the safety and efficacy of pharmaceutical products in the market.
How PharmaGXP Can Help You Achieve WDA
Regulatory Compliance
We ensure your operations adhere to the stringent standards required for WDA, safeguarding product integrity from procurement to distribution.
Documentation Preparation
We assist in the meticulous preparation of all required documentation, ensuring accuracy and completeness for a smooth approval process.
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.
Manufacturing Import Authorisation (MIA)
Manufacturing Import Authorisation (MIA)
Achieve Compliance with an MIA License through PharmaGXP
The Manufacturer/Importer Authorization (MIA) license is a mandatory license for companies that want to manufacture and import 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: We ensure your operations adhere to all required regulatory standards for WDA.
- Documentation & SOP Development: We assist in the creation and maintenance of necessary documentation.
- Application & Process Management: From initial documentation to final submission, we handle the entire process for a seamless experience.
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.
Parallel Import Product License (PLPI)
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.
Regulatory Expertise
cPharmaGXP offers in-depth knowledge of the regulatory requirements and processes involved in obtaining a PLPI license.
Strategic Planning
Our team provides strategic advice to optimize your product sourcing and maximize the economic benefits of parallel importing.
Application Support
We guide you through the entire application process, from documentation preparation to submission, ensuring all criteria are met efficiently.
Manufacturer's Special 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.
Why it is Required?
- Access to Unlicensed Medicines: This license allows the importation of unlicensed medicines that may be crucial for treating patients when no licensed alternatives are available in the market.
- Regulatory Compliance: The Manufacturer’s Special License ensures that the importation and distribution of unlicensed medicines meet the rigorous standards set by the MHRA.
- Legal Assurance for Businesses: Obtaining this license provides legal authorization for pharmaceutical companies to handle and distribute unlicensed medicines within the UK
How PharmaGXP Can Assist in Acquiring a it
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.
Controlled Drug License from Home Office
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.
Why Choose PharmaGXP?
Expert Guidance
Our team has extensive knowledge of regulatory requirements, ensuring that you remain compliant throughout the process.
Seamless Process
We manage the entire application process, minimizing stress and helping you secure your license quickly.
Dedicated Support
We offer ongoing support, from the initial consultation to maintaining the license.