Named Patient Management
1. What services do you offer under Named Patient Management?
Under Named Patient Management, we provide access to medications not yet available in a patient’s home country, support for regulatory and logistical processes, and comprehensive assistance throughout the application and delivery phases to ensure patients with serious or rare conditions receive necessary treatments.
2. Who is eligible for Named Patient Management services?
Patients with serious or rare diseases who cannot access necessary medications through regular channels may be eligible. Eligibility depends on local regulations and specific medical criteria.
3. How do you ensure compliance with local and international regulations?
We work closely with regulatory experts and follow strict guidelines to ensure all activities comply with local and international laws. This includes managing all necessary documentation and obtaining approvals from relevant authorities.
4. What types of medications can be accessed through Named Patient Management?
Patients can access a wide range of medications, including investigational drugs, off-label medications, and those approved in other countries but not yet in the patient’s home country.
5. How long does it take to obtain medication through Named Patient Management?
The timeline varies depending on the specific medication, regulatory requirements, and the patient’s location. We strive to expedite the process to ensure patients receive their medications as quickly as possible.
Clinical Trial Sourcing
1. What does your Clinical Trial Sourcing service encompass?
Our Clinical Trial Sourcing service encompasses the procurement and management of all necessary materials for clinical trials, including investigational and comparator drugs, placebos, and ancillary supplies, ensuring a smooth and efficient supply chain from sourcing to delivery.
2. What types of products do you source for clinical trials?
We source investigational drugs, comparator drugs, placebos, and ancillary supplies required for clinical trials across various therapeutic areas.
3. How do you ensure the quality of sourced products?
All products are sourced from reputable manufacturers who comply with international quality standards such as WHO-GMP, US FDA, and EU GMP. Rigorous quality control measures are implemented throughout the sourcing process.
4. Can you handle international clinical trial supply logistics?
Yes, we have a robust logistics network that ensures timely and secure delivery of trial materials to sites worldwide, handling all aspects of import/export, storage, and transportation.
5. How do you manage regulatory compliance for clinical trial supplies?
Our team has extensive knowledge of global regulatory requirements and ensures all sourced materials comply with relevant guidelines. We also manage all necessary documentation and regulatory approvals.
Generic Medicine Suppliers & Exporters
1. What services do you provide as Generic Medicine Suppliers & Exporters?
As Generic Medicine Suppliers & Exporters, we provide a wide range of high-quality, cost-effective generic medications, manage international shipping and logistics, ensure compliance with global quality standards, and offer comprehensive documentation and regulatory support.
2. How do you ensure the quality of your generic medicines?
All our generic medicines comply with international quality standards, including WHO-GMP, US FDA, and EU GMP certifications. Rigorous quality control measures are in place to ensure product safety and efficacy.
3. Do you offer competitive pricing for generic medicines?
Yes, we provide cost-effective solutions without compromising on quality, thanks to our strong relationships with reputable manufacturers.
4. Can you handle large-scale orders and international shipping?
Yes, we have the capacity to handle bulk orders and our efficient supply chain management ensures timely and secure international shipping.
5. What documentation do you provide for your generic medicines?
We provide comprehensive documentation, including Certificates of Analysis (CoA), product specifications, and regulatory compliance documents to ensure transparency and compliance.
RLD Suppliers
1. What do you offer as an RLD Supplier?
As an RLD Supplier, we offer access to a comprehensive inventory of Reference Listed Drugs (RLDs) necessary for generic drug development and bioequivalence studies, along with regulatory support, quality assurance, and efficient logistics management to ensure timely delivery and compliance.
2. Who can benefit from RLD supply services?
Pharmaceutical companies, contract research organizations (CROs), regulatory affairs teams, and biotech firms can benefit from our RLD supply services for their generic drug development and regulatory submissions.
3. How do you ensure the authenticity and quality of RLDs?
All RLDs are sourced from reputable manufacturers and comply with international quality standards. We provide proper documentation and certification for authenticity and quality.
4. Can you assist with regulatory documentation for RLDs?
Yes, we provide complete regulatory documentation support, including Certificates of Analysis (CoA), product specifications, and assistance with regulatory filings.
5. How do you handle the logistics of RLD supply?
We manage the entire logistics process, including sourcing, storage, transportation, and customs clearance, ensuring timely and secure delivery of RLDs to your location.