The development of a pharmaceutical drug is a complex, multifaceted process that requires the highest level of strategic planning and project management from beginning to end.
Our experienced regulatory team can help you design and implement a drug development strategy that will ensure compliance with Canadian (Health Canada) and U.S. (FDA) governments' requirements for prescription drugs. We help navigate the complexities of various government regulatory agencies and pathways to ensure your product is properly positioned.
Drug development services include:
Regulatory Project Management
The greatest challenge companies encounter is getting their product product developed on time and within budget. We help deliver phase I, II and III clinical trials quickly and accurately, with a commitment to make the process as streamlined and expedited as possible.
We will help you initiate early phase clinical trials (First in Man, Proof of Concept, pK/dD), leveraging your scientific expertise and our team of leading experts with our innovative and flexible solutions to ensure you move through the IND/CTA process as quickly and smoothly as possible. We can design the right pathway to confirm compound viability, identify risks and make go/no-go decisions with speed and confidence.
Our clinical trials team conducts clinical studies from complex double-blind, placebo-controlled trials to straightforward bioavailability studies for functional food and beverage products. We work with clients to provide full solutions from base concept to publication and health claim development. We can also assist with distinct components of a trial such as subject recruitment, protocol development, diagnostic testing and manuscript writing.
Once your clinical trial has been completed, we can assist with manuscript writing and submission to the scientific publication of your choice. Our Ph.D. level nutritional scientists and clinical research personnel have extensive experience preparing and editing scientific manuscripts; they will work with you to ensure your paper is completed to the highest standards and in a timely manner.
Scientific Literature Reviews
In order to investigate the safety, efficacy and health claim potential of your pharmaceutical ingredient or product, we will conduct a systematic scientific literature review based on your product objectives.
Health Claim Strategy and Assessment
Our experienced regulatory affairs team understands the importance of market access for pharmaceuticals, and will work with you to develop an appropriate health claim strategy and regulatory pathway based on your product objectives.
Drug Establishment Licencing (Canada)
Companies that fabricate, package, label, distribute, import, wholesale and/or test drugs require a Drug Establishment Licence under Division 2 of the Food and Drug Regulations.
Issued by the Health Products and Food Branch of Health Canada (HPFB), a Drug Establishment Licence authorizes the Canadian licensee to fabricate, package, label, distribute, import, wholesale and/or test a drug. This signifies Good Manufacturing Practice (GMP)-compliance to potential domestic and foreign business and helps ensure that the Canadian pharmaceutical market consists of safe and high quality drug products.
An establishment’s Standard Operating Procedures (SOPs), associated Documentation, and the facility itself are assessed against the Drug’s GMPs as part of the inspection and licensing review. Appropriate standards and practices with respect to premises, equipment, personnel, sanitation, raw material testing, manufacturing control, quality control, packaging, material testing, finished product testing, records, samples, stability, and sterile products, where applicable, should be in place.
Clinical Trial Application (CTA) and Investigational New Drug (IND) Submissions
From scheduling your pre-submission meeting with the corresponding government agency to complete Phase III trials, we will provide you with all of the components of drug development, or fill in any gaps you might be missing.
With a dichotomy of experienced professionals at Nutrasource, we are ideally positioned to help with your AND Applications, either with the Therapeutic Products Directorate (TPD) or the FDA. We can navigate the procedure from conception to completion or assist along the way with medical writing, bioequivalence testing or chemistry and manufacturing.
Facility Assessments and SOP Development
Whether you are looking to bring a facility up to GMP standards or wish to assess a site already in your pipeline, our team of experienced and efficient site management personnel are prepared to perform these tasks on your behalf.
If you are preparing for an audit and want to ensure it goes off without a regulatory hitch, we can preform a pre-audit GAP analysis according to agency standards to provide you with all the missing pieces we identify, including SOPs to Quality Manuals.
New Dietary Ingredient (NDI) Notifications (U.S.)
There has been buzz in the industry and trade press as to when a company is required under the Federal Food, Drug, and Cosmetic Act (FDC Act) to submit a 75-day premarket notification to the Food and Drug Administration (FDA) for a new dietary ingredient (NDI).
Often a company not familiar with the NDI notification process may find it difficult to determine whether they need to file an application and how to go about it. Because the new guidelines are not always straightforward, our regulatory team can supply the roadmap to determine the best course of action for your submission.
Looking for more information on pharmaceutical regulatory services? Contact a member of our team today or email us directly at firstname.lastname@example.org. You may also request a customized quote and we will contact you with details within two business days.