Pharmaceutical
At Proficio, we can resource any scientific affairs project for the pharmaceutical, medical device or Natural health Products industries – regardless of size, expectations, scope-of-work, budget or timeline. From filing submissions to the more complex management of compliance issues and post-approval activities, we are the experts in this field and can supply the market intelligence and consultants to match any scientific affairs need.
We are always up to date with current legislation, regulatory requirements, industry initiatives and interpretations of the regulations. The Proficio team boasts experience in all aspects and at all levels of scientific affairs. Moreover, our pharmaceutical therapeutic area expertise runs broad and deep. We challenge you to find a category that we have not worked in before!
Biotech
Biotechnology products are an increasingly important segment of today’s pharmaceutical landscape. Many even feel that biotech will prove to be one of the key drivers of the healthcare industry in the coming years.
Proficio can provide experts with extensive industry experience in the licensing of biologic and biotech medicinal products. Whether you are a multi-national, start-up or university, if you are looking for experts to discuss your options (from obtaining scientific advice through to filing strategies), Proficio can offer you the talent and experience you need to succeed.
Consumer products
Extending the success of a prescription drug by switching to an OTC product has become a natural step to consider for many pharmaceutical manufacturers. Undertaking such a switch requires knowledge and practical experience of the OTC regulations. Proficio can help with both prescription to OTC switches or with products developed entirely for the OTC market.
Our team has knowledge of the varying OTC regulations, and we offer full management of OTC medicines, including product submissions and authoring of consumer labelling. We have done it all and we can do it all. The consumer healthcare domain is challenging. You need a team with a proven track-record and knowledge-base.
Generics
There is nothing generic about the generic drug business. Every mandate is a challenge we relish. Whether you want to market a generic product, or biosimilar, Proficio can generate all the necessary regulatory documentation and drive these through the assessment and approval process to get your product to market quickly and efficiently.
If you are unsure of strategy, or the pros and cons of your proposed regulatory pathway, or the required development plan to ensure registration success we can help with your decision making process (and maybe even suggest something new!). We love to help you tap new opportunities and to offer you insights that drive your business forward.
Medical devices
Proficio provides a full range of consulting and contract services for the development and registration of medical devices. Our team has experience in all aspects of this field and can provide expertise in the registration of Class I-IV medical devices, plus ISO requirements.
Veterinary products
Think that our expertise is only applied to the human species? Think again. Our team has many years of experience in veterinary drug and biologics development. We have diverse expertise in all companion animal and food animal species across all major pharmaceutical and biologic product areas. Moreover, we are well-versed in novel delivery and formulation systems.
Natural health products
The regulatory landscape for natural health products is shifting and evolving. The regulations are being honed in order to allow access to a wide range of natural health products that are safe, effective and of high quality. As more and more products are offered, the emphasis is on helping natural health product manufacturers navigate these changing tides, and come out on top every time.
Due Diligence
Thinking of in licencing or acquiring a product developed by another firm? We can help! We have expertise across the entire spectrum of healthcare products, from inception to life-cycle management and can expertly assess to pros and cons of that product that may be the pivotal element in getting your organization to the next level!
New challenges
Did we mention we love a challenge? The Proficio team has never met a mountain it did not want to move. Test us. Defy us. Challenge us. Your next healthcare venture could be an adventure that is made for us!