Contract development is a business built on judgement. The formulation decisions taken in the first weeks of a project determine which markets stay open to it years later. Those decisions are made by people, so it is reasonable that you should know who they are.
When a client brings us a product, they are rarely bringing us only a formulation. They are bringing a decision — about which markets they intend to be in, what they are willing to claim, and how much risk they can carry. Our work is to help them make that decision well the first time, because in this industry the cost of getting it wrong is not a revision. It is a year.
Raised Pharma was built around that conviction. We put the regulatory pathway at the front of a programme rather than the end of it, so that a formulation developed for Canada is not quietly disqualified in Riyadh, and a claim that reads well in marketing is one we can defend in a dossier. It makes for a slower conversation at the beginning and a far shorter one at the finish.
We work across pharmaceutical, natural health and cosmetic products, in Canada, the United States, the European Union and the Gulf — as the development partner to other companies, and as the owner of products we have carried through to licence ourselves. Doing both keeps us honest. We advise our clients on decisions we have had to live with in our own portfolio.
What I ask of our team is simple, and not always easy: tell the client what the data says, not what they are hoping it says. Quality here is not a department and compliance is not a hurdle. They are the reason a product survives contact with a regulator — and the reason a client comes back to us with the next one.
If you are developing something and are not yet certain which pathway it belongs on, I would be glad to hear about it.
Leads the direction of the business across Raised Pharma’s Canadian, US and Indian operations, with overall responsibility for how the company serves clients from formulation through to regulatory registration.
Leads research and development across oral solid, oral liquid and topical semisolid dosage forms, including pre-formulation, formulation development, bioequivalence strategy and the analytical work supporting registration dossiers.
Manages regulatory submissions and dossier preparation across our markets, including CTD/eCTD and eCTD compilation, labelling review and correspondence with regulatory authorities in Canada, the USA, the EU and the Gulf.
Leads the financial management of the business — budgeting, project costing and financial planning across Raised Pharma’s Canadian, US and Indian operations — and the commercial structuring of client, supplier and partner agreements.
Product development decisions carry clinical consequences. Our advisory board brings qualified medical input to formulation, claims and safety — the areas where commercial ambition most often meets regulatory reality.
Provides medical and regulatory guidance on product development, advising on clinical appropriateness, safety considerations and the evidence needed to support claims across the markets we serve.
Advises on clinical evidence and research strategy, including the design and interpretation of the data used to substantiate product claims and support regulatory submissions.
Advises on clinical research and evidence review, supporting the assessment of safety and efficacy data that underpins product development and market registration.
Behind the names above sits a team of formulation scientists, analytical chemists, quality assurance specialists and regulatory professionals across our Canadian, US and Indian operations — the people who do the daily work of taking a product from concept to registration.
Working with us starts with a conversation. Tell us the product, the dosage form and the markets you are aiming at, and we will tell you plainly whether we are the right partner for it.
Email: info@raisedpharma.com Phone: +1 (716)-777-4800