Pharmaceutical compliance
Good Manufacturing Practice (GMP)
Good Manufacturing Practice (GMP) refers to a system for ensuring that products are consistently produced and controlled according to quality standards.
It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product. GMP covers all aspects of production; from the starting materials, premises, and equipment to the training and personal hygiene of staff. Detailed, written procedures are essential for each process that could affect the quality of the finished product. There must be systems to provide documented proof that correct procedures are consistently followed at each step in the manufacturing process – every time a product is made.
QReg's GMP Services
At QReg, we provide comprehensive Good Manufacturing Practice (GMP) consulting services designed to ensure that your medical devices and pharmaceutical products are manufactured in compliance with all applicable GMP standards.
Our service includes a thorough analysis of your manufacturing processes, assistance in establishing proper quality management systems, and guidance in maintaining consistent, high-quality production control. We help you implement the necessary procedures and train your staff to adhere to GMP protocols effectively. Our experts are well-versed in the latest regulations and can help you navigate complex compliance requirements, ultimately ensuring that your products meet both safety and efficacy standards. Whether you’re preparing for an audit or looking to improve your production practices, QReg is here to support every step of the way.
Good Laboratory Practice (GLP)
Good Laboratory Practice (GLP) is a set of principles intended to ensure the quality and integrity of non-clinical laboratory studies, which are used to support research or marketing permits for products regulated by government agencies.
GLP encompasses all aspects of a laboratory study, including preparation, performance, monitoring, recording, archiving, and reporting. It is designed to promote the quality and validity of test data, ensuring that studies are scientifically sound and that results are reproducible across different laboratories and over time. Compliance with GLP helps to assure regulatory authorities and customers that the data submitted are a true reflection of the results obtained during the study and can be relied upon when making risk/safety assessments.
QReg's GLP Services
At QReg, our Good Laboratory Practice (GLP) services are dedicated to enhancing the reliability, traceability, and overall integrity of your non-clinical development processes.
We offer expert guidance in setting up, validating, and maintaining your laboratory environments according to GLP standards. Our services include developing standard operating procedures (SOPs), training laboratory personnel, and conducting audits to ensure GLP compliance. We also assist in establishing proper documentation practices that meet regulatory expectations for data integrity and traceability. Our team, knowledgeable in current regulatory guidelines and best practices, will work closely with you to ensure that your laboratory operations can withstand regulatory scrutiny and support successful product registrations. Whether you are initiating new laboratories or optimizing existing operations, QReg is equipped to support your needs in maintaining high standards of laboratory practice.
Good Clinical Practice (GCP)
Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve the participation of human subjects.
Compliance with GCP ensures that the rights, safety, and well-being of trial subjects are protected, while also providing assurance that the clinical trial data and reported results are credible and accurate. GCP guidelines include criteria for conducting clinical trials, including how to manage the trial, the roles and responsibilities of sponsors, monitors, and investigators, and how to handle data, all with the overarching goal of protecting human subjects and ensuring the integrity of clinical trial results.
QReg's GCP Services
QReg offers a full suite of services to support compliance with Good Clinical Practice (GCP) for clinical trials. Our GCP services ensure that your clinical research meets all ethical and regulatory standards required for the conduct of clinical trials involving human subjects.
We assist with the setup and management of trials, including protocol development, investigator selection, trial monitoring, data management, and ensuring that all aspects of the trial are in compliance with GCP guidelines. Our experts provide training for all trial stakeholders on GCP requirements to safeguard participant safety and data integrity. Additionally, QReg supports the audit preparation and inspection readiness activities to ensure seamless regulatory reviews and approvals. With QReg’s support, sponsors can navigate the complexities of clinical trials with confidence, knowing they are adhering to the highest standards of safety, compliance, and ethics.
Preclinical Studies
Preclinical Studies are essential research trials conducted before clinical trials to determine the feasibility, safety, and efficacy of pharmaceuticals, biopharmaceuticals, and medical devices.
These studies are performed in laboratories using cells, animal models, and other in vitro systems to assess the pharmacological, toxicological, and pharmacokinetic properties of candidate drugs or devices. The primary goal of preclinical studies is to gather enough evidence to justify the progression to clinical trials, ensuring that the product is reasonably safe for initial use in humans. These studies adhere to stringent regulatory standards to help predict how the substance might behave in the human body, identify potential adverse effects, and establish safe dosage levels.
QReg's Preclinical Study Services
At QReg, we provide comprehensive support for your preclinical study needs to ensure that your pharmaceuticals and medical devices advance through the early stages of development with robust scientific validation and regulatory compliance.
Our services include protocol development, study design, management of laboratory activities, data analysis, and final report preparation that adheres to the applicable Good Laboratory Practice (GLP) standards. We also offer guidance on the ethical considerations and regulatory requirements specific to preclinical testing. Our team of experts will assist you in interpreting the study results and preparing for subsequent clinical trials, ensuring a seamless transition from preclinical to clinical phases. QReg’s in-depth expertise helps you mitigate risks early in the development process, optimize your research strategies, and enhance the likelihood of successful regulatory and commercial outcomes. Whether you are at the ideation stage or gearing up for regulatory submission, QReg’s tailored preclinical study services are designed to align with your scientific and business objectives effectively.
Investigational New Drug (IND) Application
An Investigational New Drug (IND) Application is a request submitted to the U.S. Food and Drug Administration (FDA) to authorize a pharmaceutical company to transport and use an experimental drug in human clinical trials.
This application is critical and required before any new drug or biologic can be legally tested on humans in the United States. The IND application must contain data from initial laboratory and animal testing, information on the drug’s composition and manufacturing process, and proposals for clinical trial protocols, including how, where, and by whom the studies will be conducted. It ensures the FDA that adequate safety measures are in place to protect clinical trial participants while assessing the drug’s safety and efficacy.
QReg's IND Application Services
At QReg, we provide specialized assistance for preparing and submitting Investigational New Drug (IND) applications. Our services encompass all aspects required for a successful IND submission, including preclinical data review, manufacturing information, and clinical trial design and protocols.
We ensure that your documentation meets all regulatory requirements for FDA review, emphasizing scientific rigor and compliance with regulatory guidelines. Our experts help navigate the complex regulatory landscape, advising on the strategic planning of pre-IND meetings, the compilation of necessary technical and scientific data, and responding effectively to FDA queries. QReg’s thorough understanding of regulatory expectations and our comprehensive approach to IND applications streamline the process, aiming to accelerate the transition from preclinical findings to early-phase clinical trials. Whether you are a startup biotech or an established pharmaceutical company, our tailored services are designed to support your goals, ensuring that your investigational drug can move forward in clinical development with regulatory confidence
Clinical Trial
A Clinical Trial is a research study performed on human participants aimed at evaluating a medical, surgical, or behavioural intervention. It is the primary way researchers discover if a new treatment, like a new drug, diet, or medical device, is safe and effective in people.
Clinical trials follow strict scientific standards to protect participants and provide reliable study results. They are conducted in phases: Phase 1 tests safety and dosage, Phase 2 focuses on efficacy and side effects, Phase 3 compares the intervention to standard treatments, and Phase 4 occurs after FDA approval to monitor long-term effects. These studies are essential for developing new treatments and improving existing therapies.
QReg's Clinical Trial Services
QReg offers comprehensive services to support the design, implementation, and management of clinical trials. With a focus on ensuring compliance with both national and international regulatory standards, QReg assists with every phase of the clinical trial process.
Our services include protocol development, site selection, patient recruitment, trial monitoring, data management, and statistical analysis. We ensure that all trials are conducted with the highest level of integrity and adherence to Good Clinical Practice (GCP) guidelines. Our team also provides regulatory submission assistance to ensure that all necessary documentation is prepared and submitted accurately and promptly. With QReg’s expertise, sponsors can conduct their clinical trials efficiently, ensuring that all regulatory, safety, and ethical standards are met. Whether you are initiating a small pilot study or a large-scale international trial, QReg has the expertise to guide you through every step, helping to bring safe and effective therapies to market faster.
Common Submission Dossier Template (CSDT) Preparation
The Common Submission Dossier Template (CSDT) is a standardized format used by regulatory authorities for the submission of medical device registration applications.
It is designed to streamline and harmonize the documentation necessary for regulatory approval across different jurisdictions, particularly in Asia-Pacific regions such as ASEAN countries. The CSDT format includes detailed requirements for presenting information on the device description, quality management, pre-clinical and clinical data, risk analysis, labelling, and other essential aspects relevant to the regulatory review process. Using the CSDT helps ensure that all necessary information is organized in a consistent manner, facilitating a more efficient review by regulatory bodies and potentially speeding up the approval process.
QReg's CSDT Preparation Services
QReg provides specialized services to assist medical device manufacturers in preparing and submitting the Common Submission Dossier Template (CSDT).
Our experts are well-versed in the specific requirements of various regulatory bodies that adopt the CSDT format and can guide clients through the intricacies of dossier preparation. QReg’s services include compiling and organizing technical documentation, ensuring comprehensive device descriptions, detailed summaries of quality management systems, pre-clinical and clinical study data, risk assessments, and labelling information in line with CSDT requirements. We also assist in ensuring that all documentation meets the high standards expected by regulatory authorities to facilitate a smooth and efficient approval process. Our team works closely with clients to customize submissions according to the unique demands of each product and target market, providing strategic advice to optimize the regulatory pathway. With QReg’s support, manufacturers can navigate the complex submission process more effectively, enhancing the likelihood of successful market entry.
Abbreviated New Drug Application (ANDA) & New Drug Application (NDA)
Abbreviated New Drug Application (ANDA) is a submission to the U.S. Food and Drug Administration (FDA) for the approval to market a generic drug in the United States.
ANDAs are required to demonstrate that the generic drug is bioequivalent to the innovator drug, meaning it delivers the same amount of active ingredients into a patient’s bloodstream in the same amount of time as the original product. This application does not require the sponsor to repeat costly clinical and animal studies originally conducted for the approval of the brand name drug.
New Drug Application (NDA),
on the other hand, is the vehicle through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing in the U.S. The data included in an NDA cover all phases of a drug’s development, from preclinical studies to clinical trials, and include details on how the drug behaves in the body and how it is manufactured.
QReg's ANDA & NDA Preparation Services
QReg offers comprehensive support for both Abbreviated New Drug Applications (ANDAs) and New Drug Applications (NDAs), facilitating the process of regulatory submissions to the FDA.
Our services include the preparation and submission of all necessary documentation and supporting data required to demonstrate a generic drug’s bioequivalence for ANDAs, or the safety and efficacy for NDAs.
For ANDA submissions, QReg assists in compiling bioequivalence studies, pharmaceutical equivalence data, and ensuring compliance with the FDA’s quality standards for generic drugs. For NDA submissions, our service encompasses all stages of drug development, from preclinical data through to Phase I-III clinical trials. We help clients in organizing the data effectively, preparing the integrated summaries of safety and efficacy, and ensuring that all manufacturing and control information adheres to FDA requirements.
Our team provides strategic regulatory guidance to optimize the submission process, identify potential issues in application data, and interact effectively with FDA reviewers. QReg’s expertise in regulatory affairs and thorough understanding of FDA expectations are critical in helping clients navigate complex regulatory pathways, ultimately leading to successful drug approvals. Whether you are looking to introduce a new innovative drug or a generic equivalent, QReg ensures that your submission is robust, compliant, and prepared for regulatory scrutiny.
Combination Products
Combination Products refer to therapeutic and diagnostic products that combine drugs, devices, and/or biological products, integrating different types of medical technology to create innovative treatments.
The U.S. Food and Drug Administration (FDA) categorizes combination products based on their primary modes of action. The development and approval process for these products can be complex due to the integration of different regulatory pathways and the need to meet the specific requirements applicable to each constituent part. Effective coordination between drug, device, and biologic functionalities is crucial to ensure that combination products are safe, effective, and manufactured to high quality standards.
QReg’s Combination Products Services – QReg provides expert regulatory and development support for combination products, navigating the complexities of multiple regulatory frameworks. Our services include strategic planning, application preparation, and regulatory compliance assistance tailored to the unique challenges of combination products. We assist clients with the FDA’s Office of Combination Products to determine the primary mode of action and appropriate regulatory pathway, whether it’s drug, device, or biologic-led.
Our comprehensive support covers all aspects of the development process, including:
- Regulatory Strategy Development: Crafting strategies that address the regulatory requirements of all constituent parts (drug, device, biological).
- Pre-market Submission Preparation: Assisting in preparing and reviewing submissions, including Investigational New Drug applications (INDs), Premarket Approvals (PMAs), 510(k) submissions, and Biologics License Applications (BLAs), ensuring that they meet the specific standards for combination products.
- Quality System Integration: Guiding the integration of quality systems and manufacturing practices that comply with both drug and device standards.
- Clinical Trial Design and Support: Designing and implementing clinical trials that effectively evaluate the integrated product functionalities and interactions between drug, device, and biological components.
QReg leverages its extensive experience with combination products to ensure effective communication with regulatory bodies, comprehensive documentation, and a streamlined approval process. We help our clients innovate safely and efficiently, bringing their combination products to market with confidence.