product development
Late Development
Late stage product development primarily focuses at demonstrating efficacy, safety, manufacturability, and cost-effectiveness of the product. Products that enter this stage are assumed to have completed preclinical laboratory testing and preliminary regulatory approvals to move to this next phase, such as IND, CTA, IDE or ITA.
We assist late stage companies at various stages:
Manufacturing and Scale up
Scale up and manufacturability of the prototype and validation of all expected specifications needs to be complete before going into regulatory filing. A minimum viable product (MVP) is essential for regulatory filing including submission of clinical trials design.
We are manufacturers ourselves. We can get involved in any step, from product development to large volume manufacturing, liquid dose, solid dose, gels, medical device, or even food product manufacturing, and support through the process.
Please reach out for further information or for specific enquiries.
Regulatory Compliance
Safety audits, Quality and Compliance of manufacturing and packaging processes, Site License application.
Microbiological Risk
Contamination tracing and control, Verification and Validation of microbial testing procedures, and Laboratory design. OOS, OOL, OOT.
ERP Implementation
Analyze existing workflow, configure, customize and align processes, clean and prepare data for import, design reports.
Project Management
Project management is the process of planning and prioritizing resources to accomplish a specific task. Life science projects are often complicated and have a lot of complex moving parts. The real challenge is often in coordinating each part to successfully achieve objectives in a given time and budget.
Process Optimization
Life science products are complex. Processes involved in manufacturing are never simple and have very strict compliance requirements. Without a systematic approach of analyzing and improving manufacturing and other business processes, both productivity and efficiency will suffer. It often leads to incredible loss of resources as well.
Vendor Qualification
US-FDA 21 CFR 211, US-FDA 21 CFR 111, Health Canada for both drugs and Natural Health Products, all require vendor qualification for product compliance. Typically it is performed with a checklist however site visits are often recommended.
Market Penetration
Market penetration is a direct measure of how well target customers like your product compared to the competitors' product(s).
Products have to be usable, attractive, well positioned, and in demand before market success can be expected. Without a clear understanding of the market penetration strategy, no product can succeed in the market place.
We have spent most of our lives running and developing life science businesses. We have a lot of experience in each of these areas.
Products have to be usable, attractive, well positioned, and in demand before market success can be expected. Without a clear understanding of the market penetration strategy, no product can succeed in the market place.
We have spent most of our lives running and developing life science businesses. We have a lot of experience in each of these areas.
Please reach out for further information or for specific enquiries.
Business Strategy
Strategy can be considered bringing a new product to market. A business strategy is an organization's master plan that the leaders of the company implements to achieve their strategic goals. A business plan captures the steps the company will take to reach its goals, what resources will be required, what does a winning team look like, and how will it measure value creation.
Marketing Strategy
Marketing strategy defines the course of action the company will take to promote and sell its products or services. Every product and its competition defines how a product is introduced to its consumers. Product design, quality, features, branding, packaging, positioning, price point, distribution channels, promotions, all play important roles in the success of the product.
IP Strategy
An Intellectual Property (IP) strategy is a company's plan of action to manage and protect its intangible assets. For innovative companies, IP plays a very important role in market leadership and growth. IP strategies also extract value from existing products and services to create new revenue streams.
Regulatory Strategy
Majority of the life science products are meant for human use. Therefore they need to be safe and efficacious for human use. Each country has their own regulatory framework through which efficacy and safety is proven.
Please see below for more details.
Corporate Intelligence
Entry to the North American market requires due diligence. Good knowledge of industry trends, knowledge of political and economic climate, regulatory framework, and without all that, succeeding will be hard.
We work with partners who are experts in such areas.
Sales Channels
Proper selection of sales channels is very important for life science products. We do not focus on any of these areas ourselves and rely on experts. We have organizations specializing in retail, wholesale, direct-to-consumer and B2B that we partner with.
Regulatory Strategy
Regulatory Strategy for Therapeutics
This section is specific for therapeutic development and commercialization. Many OTC products fall into this category although they may not require physician prescriptions. Please reach out for further information or if you have specific enquiries.
IRB and REB
Products to be tested on humans, require ethics approvals. We assist sponsors in clinical trial design, development of Standard Operating Procedures, and obtain an IRB (USA) and a REB (Canada).
NDA and NDS
Regulatory support for both New Drug Application (NDA) and New Drug Submissions (NDS) to Health Canada
Advisory Services
No two businesses are alike. Our advisory services will differ for each client. Please contact us for evaluating your unique situation. If there are specific projects that you need support on, please reach out. We will get you the help.
Regulatory Strategy for Medical Devices
This section is specific for medical device development and commercialization. These are some of the most requested services. Please reach out if you require any other specific support.
IRB and REB
Products to be tested on humans, require ethics approvals. We assist sponsors in clinical trial design, development of Standard Operating Procedures, and obtain an IRB (USA) and a REB (Canada).
510K, PMA and MDL
Regulatory support for both 510k Pre-market Notification and Pre-market Approval (PMA) applications to the FDA and Medical Device License (MDL) applications to Health Canada
Advisory Services
No two businesses are alike. Our advisory services will differ for each client. Please contact us for evaluating your unique situation. If there are specific projects that you need support on, please reach out. We will get you the help.
Regulatory Strategy for Consumer Health Products
Consumer health products are sold directly to consumers. These include Disinfectants (e.g., contact lens solution), Cosmetics (e.g., make-up, shampoos), and Dietary supplements/ Natural health products (e.g., vitamin and mineral supplements, traditional and homeopathic medicines, probiotics, toothpastes). Please see therapeutics section for OTC drug products.
Food products are a little different. However, many food products fall under NHP regulations (under Health Canada) or dietary supplements (under US FDA). It is best to evaluate each food product individually.
IRB and REB
Products to be tested on humans, require ethics approvals. We assist sponsors in clinical trial design, development of Standard Operating Procedures, and obtain an IRB (USA) and a REB (Canada).
NDI and NPN
We provide regulatory support for New Dietary Ingredient (NDI) application to the FDA and a Natural Health Product Number (NPN) application to Health Canada. We help with a proper label development which is crucial for approval.
Advisory Services
No two businesses are alike. Our advisory services will differ for each client. Please contact us for evaluating your unique situation. If there are specific projects that you need support on, please reach out. We will get you the help.