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Have a project, or idea but don’t have the expertise or space to make it successful? ARSI can help!
CMC Consulting
One of the major areas of our pharmaceutical consulting services is CMC consulting. CMC (Chemistry, Manufacturing and Controls) consulting is a specialized form of consulting that assists pharmaceutical companies in the development and implementation of strategies to ensure that their drugs meet regulatory requirements.
It typically involves guidelines for all aspects of the development and manufacturing of drug substances and products, including formulation, process development, analytical method development, regulatory filings, manufacturing and control systems, and quality assurance.
Why ARSI for CMC Consulting
ARSI Canada’s Drug Development (API) Consulting services increase the value of development projects and operational strategies by bringing together a wide range of expertise across all key R&D functions to support our client’s decision-making. Based on thorough, data-driven assessments, we help you to build robust drug development strategies.
Each of our consultants has a wealth of industry knowledge and expertise in various therapy methods and disease areas. This allows us to build project strategies that match the precise CMC needs of each client. Sound CMC strategy and execution frequently save time and financial resources by approaching possible challenges early in product development.
Additionally, our CMC experts often work in an integrated fashion with other disciplines on broader consulting services, helping to ensure an aligned path forward for our clients.
Our CMC capabilities
- Pharmaceutical development strategy
- CMC regulatory support (IND, NDA/BLA, agency interactions)
- Quality management systems
- cGXP compliance audits and preapproval inspections
- CMC due diligence for BD transactions
- Upstream supply chain planning and implementation
- Downstream supply chain and related distribution licensing &; GDP requirements
Our regulatory affairs consultants can help you devise effective regulatory strategies to place you on the best path forward, helping you avoid regulatory delays and overcome critical regulatory hurdles.
Regulatory consulting in drug development is a service that provides guidance and support to pharmaceutical companies to ensure they follow the regulations and guidelines associated with developing new drugs. Regulatory consultants help companies identify and understand the applicable laws and regulations that apply to the development of their drug, as well as assist with preparing required documents for regulatory submissions. They advise on how to best meet local regulatory authorities' requirements and provide ongoing support throughout the drug development process. We have a strong regulatory team to support all of your regulatory needs.
IND & ANDA submission
Having prepared CMC sections for dozens of IND applications, ARSI Canada is skilled in authoring and reviewing the CMC regulatory sections required for initiating human clinical trials. Our extensive experience supports initiating your phase I studies as quickly and efficiently as possible to advance clinical development in the pharmaceutical industry.
IND and ANDA submissions are filings made to the US Food and Drug Administration (FDA) to gain approval to market a new drug. An Investigational New Drug (IND) submission is made when a company wants to test an investigational drug in humans for the first time. An Abbreviated New Drug Application (ANDA) is a filing made when a company wants to market a generic version of an already approved drug.
Our regulatory team is well-equipped to support all these regulatory submissions.
Project Management
Project management consulting in the drug development process provides advice, guidance, and support to drug development teams to maximize the effectiveness of their projects. This includes guiding project design and implementation, identifying and addressing risks, and ensuring that projects are completed on time and within budget. Project management consultants can also advise on process improvement, project governance, and other areas related to drug development. Our expert PM team is capable of delivering complete project-related services and solutions.
R&D Technical & Medical Writing services
We offer fully professional technical writing services for Pharmaceuticals & Biotech R&D and medical device industries. We will work with your chemistry laboratory personnel and write or review all development and validation procedures for drug substances and drug products, protocols, methods, and technical reports. We can help you to write Standard Operating Procedures (SOPs), Deviations and Change Control reports, and review technical data, documents, and proposals as required.