Market Analysis, Scientific & Commercial Due Diligence
Realizing the full potential of stem cell technologies can be challenging. Simply Cells can help you thoroughly understand the stem cell market, customers, trends, legislation, regulations or a new geographic market. If you are considering acquiring a company, Simply Cells will help you overcome the technical and scientific uncertainties; provide a company’s current and projected performance; the likely penetration of a new technology and provide an analysis of the market conditions and industry/competition.
Sales & Marketing, Public Relations & Fundraising
Simply Cells has extensive experience of advertising, marketing, public relations, and sales of stem cell products and instruments for both clinical and research applications. Want to promote your stem cell product portfolio, brand your business with thought provoking press releases? We will help your business get a competitive edge in preparing press releases, marketing campaigns, catalogues, email flyers, brochures, application notes and technical product descriptions. If you’re attending a conference and are short on resources, we can provide knowledgeable sales support for your stand or deliver expert presentations on your behalf.
Business Development & Interim Project Management
Strategic planning is the foundation of a successful regenerative medicine business. Understanding your market needs and customer requirements can be elusive where Disruptive Technologies, like stem cells and regenerative medicine, are involved. Simply Cells can support your business development plan in order to focus Research & Development in line with the expectations of your business. We provide operational management, risk management, reporting of results and budget forecasting.
Clinical Development, Quality Assurance & Regulatory Affairs
Understanding the expectations and requirements of the regulators is a key element to address early in the development of a regenerative medicine therapy. For example, the theoretical close association between stem cells and cancer requires a strong emphasis on safety and toxicology testing of stem cells from the outset. Simply Cells offers the necessary expertise to navigate thorough the regulatory and submission procedures for the governing bodies in the following countries: FDA (in the United States), TGA (in Australia), MHRA (in the United Kingdom), PEI (in Germany) and EMA (European wide). Whether you are in an academic or commercial setting, Simply Cells will provide you with clarity and vision to address the downstream challenges early in a project plan.
Engineering, Design & Manufacture of Stem Cell Based Medicines
Regardless of whether it’s your first commercial prototype design or improvement to your next generation product, Simply Cells’ extensive expertise will ensure you have the technical insight and knowledge to streamline the development of that product. From sourcing tissue to stem cells, Simply Cells provides all the resources and expertise you need for your product development programme. We can help guide you through the Human Tissue act (HTA) and Good Tissue Practice (GTP) regulations to complex biological reagent sourcing for clinical applications of stem cells and GMP/GLP manufacturing strategies and approaches.
Technical Writing & Stem Cell Training Courses
Whether it’s for a grant proposal, marketing, brochure or regulatory dossier, the secret to successful technical writing is to translate complex scientific technologies into coherent commercial benefits. Whether you are in a commercial or academic setting, Simply Cells will will ensure your literature is targeted towards the desired audience, adding real value to your grant or fundraising drive, marketing and sales campaign, publication, patent and regulatory application. From drafting or reviewing, we also provide technical writing to support quality control procedures such as Standard Operating Procedures (SOPs), Specifications and Change Control.