Consultancy Services

CMC SERVICES
IND, NDAs and ANDAs
DMF Filling
DMF Deficiency Response
Impurity Profiling
Justification of Specifications

LABORATORY DESIGN AND ENGINEERING
Scheduling, Monitoring, and Controlling
Safety, Hygiene, and Environment
Source and supply materials

API SYNTHETIC SUPPORT AND TECHNOLOGY TRANSFER
End to End Support
ROS Evaluation
Contact Development
Contact Manufacturing
Vendor Selection

QUALITY COMPLIANCE
GMP Compliant Quality System
Deviation and CAPA management
Compliant Handling and Management

REGULATORY COMPLIANCE
Establishment License Applications and Amendments
Product License Application and Amendments
Dossier Preparation & Submissions in CTD and eCTD

JSI Research Chemicals Inc. is a specialized company based in Canada that offers a range of services and solutions to the global life sciences industries. Here is a detailed description of the services and expertise provided by JSI Research Chemicals:

API Synthesis: JSI specializes in the synthesis of Active Pharmaceutical Ingredients (APIs), which are the key components of pharmaceutical drugs. They have expertise in designing and producing these essential compounds.
Impurities Synthesis Profiling: The company is experienced in identifying and characterizing impurities in pharmaceutical products. This is crucial for ensuring the safety and efficacy of drugs.
CMC writeup and review service: JSI Research Chemicals assists pharmaceutical companies in the preparation of comprehensive CMC documents. These documents are essential for regulatory submissions, including Investigational New Drug (IND) applications, New Drug Applications (NDAs), and Abbreviated New Drug Applications (ANDAs).
Quality by Design (QbD) Process and Method Development: JSI Research Chemicals focuses on Quality by Design, a systematic approach to drug development that emphasizes product quality and patient safety. They work on developing processes and methods that meet high-quality standards.
Technology Transfer: JSI assists in the transfer of technology, which is vital for scaling up production or transferring manufacturing processes from one location to another.
DMF Filing: Drug Master File (DMF) submission is a regulatory requirement for APIs. JSI can help in preparing and filing DMFs, ensuring compliance with regulatory authorities.
Regulatory Query Response: They assist in addressing and responding to regulatory queries and requirements, ensuring compliance with regulatory agencies.
Onsite, Offsite, or Online Corporate Trainings: JSI offers training services for pharmaceutical and life sciences companies. These training programs can be conducted onsite, offsite, or online, depending on the client’s needs.
Research and Development Support: The company provides support for research and development activities, helping clients in the pharmaceutical industry advance their product development efforts.
Quality Assurance and Regulatory Affairs: JSI offers services related to quality assurance and regulatory compliance, ensuring that products meet the required standards and adhere to regulations.
Pharmaceutical Quality Assurance and Quality Control: JSI assists in setting up quality assurance and quality control processes, which are critical in pharmaceutical manufacturing to maintain product quality and safety.
SOPs Preparation: JSI helps in the preparation of Standard Operating Procedures (SOPs), which are essential documents for ensuring consistent and standardized processes within a pharmaceutical company.
Inspection, Pre-Audit, Audit: JSI offers support for inspections, pre-audits, and audits to ensure that a company’s operations and products meet regulatory requirements.
Create and Maintain Quality System: JSI helps to establish and maintain a robust quality management system that complies with industry standards and regulations.
GMP, Site, and Establishment Licensing: JSI provides expertise in Good Manufacturing Practices (GMP) and assist in obtaining site and establishment licenses.
Regulatory Submissions and Marketing Authorizations: JSI supports the preparation and submission of regulatory documents for pharmaceuticals, biologics, and medical devices, helping clients secure marketing authorizations.
Validation (Cleaning, Process, Computer): JSI offers validation services, including cleaning, process, and computer system validation, ensuring that systems and processes are operating correctly and consistently.
Laboratory Set-Up, Equipment Qualification, Calibration, and Maintenance: JSI assists in setting up laboratories, qualifying equipment, and ensuring their calibration and maintenance for accurate and reliable results.
Laboratory Safety Training: Safety is a top priority in laboratories, and JSI provides training to ensure that personnel are well-versed in laboratory safety protocols.
GMP and Safety Training: JSI offers training in Good Manufacturing Practices (GMP) and safety protocols, ensuring compliance with industry standards and safety regulations.

JSI Research Chemicals Inc. provides comprehensive and integrated solutions for companies in the life sciences and pharmaceutical industries, helping you meet quality, regulatory, and safety requirements in your product development and manufacturing processes.

CMC Services

JSI Research Chemicals Inc. offers a range of services related to Chemistry, Manufacturing, and Controls (CMC) writeup and review for pharmaceutical and life sciences industries. CMC documentation is a crucial aspect of drug development and regulatory approval, focusing on the manufacturing and quality control of pharmaceutical products. Below, I will detail the CMC writeup and review services provided by JSI Research Chemicals:

CMC Document Preparation: JSI Research Chemicals assists pharmaceutical companies in the preparation of comprehensive CMC documents. These documents are essential for regulatory submissions, including Investigational New Drug (IND) applications, New Drug Applications (NDAs), and Abbreviated New Drug Applications (ANDAs).
Quality by Design (QbD) Integration: We specialize in incorporating Quality by Design principles into CMC documentation. QbD is an approach that emphasizes a systematic and science-based understanding of product and process to ensure quality and consistency. JSI helps clients integrate QbD elements into their CMC documentation.
CMC Regulatory Strategy: JSI Research Chemicals can provide guidance and support in developing a CMC regulatory strategy. This includes advice on how to meet regulatory requirements, optimize manufacturing processes, and ensure product quality and safety.
Impurity Profiling: Identification and characterization of impurities in pharmaceutical products is crucial for CMC documentation. Our expertise in impurity profiling ensures that clients receive comprehensive information about impurities in their drug products.
Batch Record Review: JSI Research Chemicals conducts thorough reviews of batch records to ensure that they are accurate and compliant with regulatory standards. This is vital for maintaining product quality and consistency.
Validation Documentation Support: We offer assistance in preparing and reviewing validation documentation, which includes cleaning, processing, and computer system validation. Validation ensures that manufacturing processes and systems are reliable and meet quality standards.
CMC Document Audits: JSI performs audits of existing CMC documentation to identify areas of improvement, compliance gaps, and opportunities for optimization.
Regulatory Query Response: In the event of regulatory queries or requests for additional information, we are here to help clients formulate comprehensive responses that address regulatory concerns effectively.
CMC Document Revisions and Updates: Regulatory requirements and manufacturing processes can change over time. JSI assists in revising and updating CMC documentation to ensure ongoing compliance and adherence to best practices.
GMP Compliance Support: Good Manufacturing Practices (GMP) are essential for pharmaceutical manufacturing. JSI Research Chemicals provides support to ensure that CMC documentation aligns with GMP requirements.
Regulatory Submissions Assistance: JSI helps clients compile CMC data for regulatory submissions and assists in preparing the documentation required for regulatory filings, such as the Common Technical Document (CTD).
Customized Solutions: Our company tailors its CMC writeup and review services to the specific needs of each client, recognizing that different pharmaceutical products and manufacturing processes may require unique approaches.

By offering these services, JSI Research Chemicals aids pharmaceutical and life sciences companies in developing, maintaining, and improving their CMC documentation, which is essential for obtaining regulatory approvals and ensuring the safety and quality of pharmaceutical products. Our expertise in CMC writeup and review plays a vital role in the drug development and approval process, contributing to the success of its clients in the highly regulated pharmaceutical industry.

Laboratory Design and Engineering

Welcome to JSI Research Chemicals, where excellence and safety are not just priorities but prerequisites. Our team of professionals is dedicated to delivering exceptional results, ensuring the happiness and safety of all our customers. With a track record of successful projects, we take great care in adhering to local Environment, Health & Safety regulations and policies throughout the construction management process.

Our Construction Management services encompass a wide range of critical functions, including:

Scheduling, Monitoring, and Controlling: We meticulously plan and oversee construction and installation activities to ensure timely and efficient project execution.
Progress Reporting: We provide weekly and monthly activity progress reports, highlighting any slippages and suggesting strategies to expedite work, ensuring complete transparency in our operations.
Site Logistics Management: Our team is well-versed in managing site logistics, optimizing resources, and streamlining operations for maximum efficiency.
Variations and Contractor Coordination: We monitor variations and re-plan contractors’ activities as needed to adapt to changing project requirements.
Billing Certification: We meticulously check and certify bills to ensure accuracy and fairness in financial transactions.
Safety, Hygiene, and Environment (SHE): The safety, hygiene, and environmental well-being of our projects are a top priority. We have strict controls and monitoring procedures in place to maintain these standards.
Quality Control: We monitor the quality of materials arriving at the site for each discipline, ensuring that they meet specifications and quality standards.
Design Information: We make sure that all design information is readily available. In case of deficiencies, we provide or obtain the necessary amendments or revisions required to meet field requirements.
Source and supply materials: Our laboratory supplies and furniture team can provide custom made world class laboratory furniture.
Site Performance Testing: We conduct site performance tests for mechanical installations to guarantee their functionality and reliability.
As-Built Documentation: We diligently compile and maintain As-Built documentation for the project, ensuring that all essential information is recorded and updated for future reference.

Our experience extends to setting up a wide range of laboratory facilities, including:

Wet Chemistry Labs
Instrument Labs
Analytical Development Labs
Product Development Labs
Formulation Development Labs
Nutritional Labs
Synthetic Chemistry Labs
Peptide Labs
API Kilo Labs
Biotech Labs
Food Testing Labs

At JSI Research Chemicals, we are committed to turning your vision into a reality, while also upholding the highest standards of safety, quality, and efficiency. Your project is in capable hands with our experienced team. Contact us today to discuss your laboratory setup needs and experience the JSI difference.

API Synthetic Support and Technology Transfer

JSI Research Chemicals offers a comprehensive range of services in the pharmaceutical industry, focusing on technology transfer, contract development, and regulatory support. Here’s a breakdown of the services provided:

1. Technology Transfer:

Technology transfer between product development and manufacturing.
Transfer between manufacturing locations, both internally and between different companies.
Ensuring continuity of supply, safety, quality, and compliance during the transfer.
Planning and executing technology transfers carefully and efficiently.

2. API (Active Pharmaceutical Ingredient) Development:

Specialized in synthesizing various types of APIs, including generics and new developments.
Capable of preparing APIs on scales ranging from milligrams to kilograms.
Advisory role to improve yield, minimize by-products, and reduce effluent load for cost-effectiveness.

3. Tailor-Made Solutions:

Customized technology transfer solutions, including process and analytical know-how.
Transfer at any stage of the API lifecycle (lab, pilot, commercial phase).
Exclusive transfer options, such as outsourcing or site transfer.

4. Network Development:

Assistance in developing a network of qualified suppliers for sourcing basic chemicals, starting materials, reagents, and intermediates (both non-GMP and GMP).

5. Development Services:

Support throughout the development stages, from project conception to final documentation submission.
Services include literature evaluation, patent landscape analysis, feasibility trials, upscaling, and process optimization.
Focus on developing sustainable, robust, cost-effective processes.

6. Project Management:

Committed project managers with scientific and expert backgrounds to oversee and execute projects according to client expectations and targets.

7. Regulatory Support:

Intellectual property services, including Freedom to Operate (FTO) analysis and patent applications.
Quality management and regulatory affairs support, including strategy development and registration assistance.
Provision of reference and impurity standards as needed.

8. CDMO and CRO Services:

Support in bringing pharmaceutical products from development to production.
Smooth transfer of development work to designated production sites.

Additional Services:

Freedom to Operate (FTO) analysis.
Route of Synthesis exploration and evaluation.
Vendor screening and evaluation for starting materials and intermediates.
Feasibility studies and lab development.
Specifications development.
Analytical method development and validation.
Process development and scale-up for commercial production.
Cleaning validation and process validation.

Genotoxin, N-Nitrosamine, and elemental impurities screening and risk assessment reports.
Synthesis of impurities, reference standards, and more.
Salt screening, co-crystal screening, and polymorphism studies.
Regulatory services, including preparation of CMC (Chemistry, Manufacturing, and Controls) sections or complete Drug Master Files (DMF) write-ups.

JSI Research Chemicals aims to provide comprehensive support to pharmaceutical companies at every stage of their product development and manufacturing processes, ensuring quality, compliance, and successful technology transfers.

Quality Compliance Consulting Services

We provide a list of services related to Good Manufacturing Practice (GMP) and regulatory compliance in the pharmaceutical industry. These services are crucial for ensuring the quality, safety, and regulatory compliance of pharmaceutical products in Canada and potentially in other countries. Here’s a breakdown of each of these services:

3rd Party Audit Services and Gap Analyses: Conduct audits and gap analyses to assess compliance with Health Canada requirements for various pharmaceutical products, including APIs, OTC drug products, excipients, and natural health products.
Development and Implementation of GMP Compliant Quality Systems: Establish and maintain GMP-compliant quality systems, including the preparation and upkeep of Standard Operating Procedures (SOPs).
Host Compliance Inspections: Prepare for and host compliance inspections by regulatory authorities such as the FDA and Health Canada. This includes assisting with product release as part of quality control.
Ongoing Quality Control and Quality Assurance: Provide continuous quality control and assurance services to maintain product quality throughout its lifecycle.
Host Regulatory Health Canada Inspections: Manage the entire process of hosting and assisting with Health Canada inspections, covering various types of licenses and regulations.
Host or Assist with Other Inspections/Audits: Support or manage inspections and audits, including third-party supplier audits and internal self-inspections.
Preparation of Specifications: Develop and maintain specifications for raw materials, intermediates, and APIs in compliance with Health Canada and FDA requirements. This may also involve future method validation and testing.
Stability Studies: Design and implement stability studies to determine product shelf life, support ongoing stability programs, and assess temperature excursions from labeled storage conditions.
Deviation and CAPA Management: Handle and manage deviations (non-conformances), and corrective and preventive actions (CAPA) to address and resolve quality issues.
Master Production Documentation: Review, approve, and maintain master production documents, including process validations, method validations, and batch production records.
Customized Training Services: Offer training programs for personnel, including technical, maintenance, cleaning, warehouse, production line, and quality staff. This includes startup training and annual GMP training.
Managing Product Recalls: Manage product recalls, including health hazard evaluation, and classification of recalls according to regulatory guidelines.
Complaint Handling and Management: Handle and manage customer complaints related to product quality and safety.

These services are essential for pharmaceutical companies to ensure compliance with regulatory requirements, maintain product quality, and uphold patient safety. They contribute to the overall success of pharmaceutical operations by ensuring that products meet the necessary standards and regulations.

Regulatory Affairs Consulting Services

JSI Research Chemicals provides a wide range of regulatory and compliance services related to pharmaceuticals, natural health products, medical devices, and cosmetics in Canada. Here’s a breakdown of the services we offer:

Establishment Licence Applications and Amendments (DEL, NHP Site License, MDEL):

Assistance with the acquisition, maintenance, and renewals of Establishment Licences for drugs (DEL), natural health products (NHP Site License), and medical devices (MDEL).
Activities including fabricating, packaging, labeling, testing, and importing.

Product Licence Applications and Amendments:

Help with the application and amendments for product licenses for drug substances, natural health products (NHP Product License), and medical devices (MDL).
Specific areas covered for natural health products include traditional herbal medicines, homeopathic products, compendial submissions, non-compendial Class 2 & 3 submissions, and finished product specifications.
For medical devices, assistance is provided for Class II, III, and IV devices, as well as private label products.

Label Reviews:

Conduct label reviews for drugs, food, medical devices, and natural health products to ensure compliance with Health Canada requirements.
Services include pre-approval label reviews for products, cartons, inserts, and product monographs.
Post-approval label reviews to address regulatory compliance issues with marketing authorizations.
Advertising reviews and ingredient reviews are also part of label review services.

Cosmetic Product Consulting:

Offer consulting services related to cosmetic products.
Conduct labelling reviews for cosmetic products, including product, carton, and insert labels.
Perform advertising reviews to ensure compliance.
Review ingredients according to the International Nomenclature for Cosmetic Ingredients (INCI).
Evaluate formulations against relevant regulations, such as the Hot List.
Address regulatory compliance issues.
Assist with Cosmetic Notification applications.

These services are valuable for businesses operating in the pharmaceutical, natural health product, medical device, and cosmetic industries in Canada. They help ensure that companies meet the necessary regulatory requirements, maintain compliance, and navigate the complex regulatory landscape to bring their products to market and keep them there in accordance with Health Canada regulations.

Quality Compliance Supports List:

Development of Qualification Protocols for Equipment & Automation
Standard Operation Procedures (SOP) for Process and Quality Control
Factory Acceptance Test
Site Acceptance Test
Development of DQ, IQ, OQ and PQ Documents
Review and Develop User Requirement Specification (URS)
Review of Functional Design Specification (FDS) of equipment
Qualification Schedule
Quality Management System
Validation Master Plan (VMP)
Cleaning Validation
Equipment Validation
Method Validation
Utility and Facility Validation
Computer System Validation
PLC HMI and Automation Validation
Risk & Impact Assessment

Regulatory Compliance Supports List:

Preparation of Drug Substance and Drug product registration dossier
Dossier Preparation & Submissions in CTD and eCTD
Drug Firm Establishment Registration
Preparation of DMF [Drug Master Files]
Critical Review of Dossiers
Compliance audits as per current and updated statutory pharma regulations
GAP Analysis
Liaison for FDA and Health Canada Registration
Support in Outsourcing Manufacturing or Testing Laboratories for Clients
Strategic assistance in Pharma Regulatory filing
Support in Outsourcing Manufacturing or Testing Laboratories for Clients
Site Master file as per Local FDA requirement
DMF Deficiency Response
Nitrosamine Risk Assessment Report
Elemental Risk Assessment Report
Impurity Control Discussion and Specification Justification Support