1. Molecular Biology/ Protein Characterization
If you don't have all the laboratory equipment to carry out every molecular genetic technique in the book, look at outsourcing to a lab that does. For example, many labs offer services like DNA sequencing or gene cloning to companies looking to outsource to people with specialized skills and equipment.
2. Fermentation Development
Maybe genetics is your forte and you've cloned the gene you want, now you can outsource the scaleup of your new GMO to specialists in fermentation and let them figure out the optimum growth conditions for production.
Now it's time to purify your bioproduct. Many companies specialize in protein purification methods and have the scaled up systems in place for batch processing. If you are a smaller biotech startup, it's likely more cost-effective to outsource this process, at least while still in clinical trials.
4. Pre-Clinical TestingNot too many people know all the in's and out's of getting a product to clinical trial. Consulting with the experts, knowledgible of all the safety, documentation and data-sharing requirements will help expidite your progress.
5. Regulatory or Patent FilingAnother area where experience and specialized know-how puts you at an advantage is when it comes to filling out the complex paperwork and/or legal documents associated with filing for approvals or patents. Biochemists who specialize in laboratory procedures can't be expected to know everything about the approval process and expert legal advice can help you maximize returns on your investment by protecting your IP.
6. Quality ManagementImplementation of a quality management program involves proceedings and paperwork that only the experts can wade through without undo stress. IT management and data storage might also fall under this category, since accurate record-keeping is part of the QA/QC process. Technical writing is another area where quality and consistency are required, and a proficiency in writing is an asset.
7. Office Administration
You may or may not know all there is to know about accounting, filing taxes, payroll and other administrative duties, but finding time to do it is another issue. Finding an expert, even a part-time or temporary service during busy times of the year, can leave you free to focus on product development. Other areas of business management you can outsource include staffing/recruiting, IT outsourcing, and administration of health and safety programs.
8. ManufacturingWhen a new drug goes to clinical trial, it might not always be economically advantageous to design and/or build a production facility capable of providing enough high quality drug for testing. Some CSOs specialize in processing batches of biologicals or pharmaceuticals that meet quality control criteria. Outsourcing of full-scale production, or the manufacture of active ingredients might also be cost-effective choices for biotech startups.
9. Packaging and Marketing
It's not uncommon to hire a marketing company to assist with publicity, advertising and promotion in any business. Experts in this area might also assist in the design of packaging, for aesthetic appeal. When it comes to regulatory requirements, however, the choice to outsouce to professionals who know the laws of the target country could save much time and avoid complications.