The biotech sector is expanding quickly every day. Life science consultants are becoming increasingly sought after, so SMBs may quickly acquire specialized knowledge.
Living things and materials are used in biotechnology to produce valuable goods and innovations. Pharmaceutical and healthcare, food, the environment, and agriculture are some of their applications. Johnson & Johnson, Pfizer, Novartis, Roche, Sanofi, and Merck are some of the leading pharmaceutical firms in the world that provide a variety of biologics and biotech-based treatments.
All biotech companies, regardless of size, must go through a rigorous regulatory process before medication may be sold. Each product results from thorough research that requires various abilities, including data analysis, statistics, and writing. While businesses with substantial expenditures may have internal resources, smaller companies usually contract these duties to life science strategy consulting in Boston.
Here are the top biotech contract services provided by industry professionals.
Consulting in regulatory matters: Businesses might benefit from the assistance of regulatory affairs experts with their offered regulatory strategy, gap analysis, transplant registration, and regulatory contacts.
Regulatory medical writers can assist with submissions to the Center for Devices and Radiological Health (CDRH), Center for Drug Evaluation and Research (CDER), and Center for Biologics Evaluation and Research (CBER) (CDRH). The development of clinical evaluation reports (CERs) for MDR compliance is also supported by medical device businesses worldwide (some of which are divisions of biotech/pharma corporations).
Life science consulting services: The creation of company strategy and the R&D operations necessary to create and introduce a successful product to the market might be assisted by qualified industry specialists.
Experts in genetics and genomics can offer advice on gene therapy and editing, while biotechnologists can offer suggestions on methods for producing lab-grown meat.
Here are some examples of how life science consultants might be of assistance:
- Scaling-up and scaling-down of processes, closure, and automation
- Scale-up strategy for processes,
- Important factors for formulation development
- Strategy for scaling back processes and troubleshooting
- Creation and development of media
- Either choosing the media or altering the media
- Regulatory framework for the creation of media formulations
- Cell reprogramming and gene editing
- Design of CRISPR knock-in and knock-out methods
- Procedures for TALEN
- siRNA and other transfection techniques for gene editing
- Design and selection of the miRNA sequence
- Development of cellular iPSC, CAR-T, MSC, NK, HEK, and viral LVV, AAV vector processes
- Help for entrepreneurs producing lab-grown meat Cell-based meat techs
- Help with optimizing distinct iPSC differentiation techniques to blood and non-blood lineages
- Product development for biologics
- Aid in facilitating the shift from 2D to 3D culture
- Help with optimization for industrial manufacturing
Statistical and Clinical Services: All sizes of biotech companies require assistance with clinical trials and data. Small biotech companies frequently contract this job to experts or hire experts to validate their results and improve tests.
A clinical trial consultant can advise on sample size, study methodology, data gathering techniques, validation techniques, and data processing. Biostatisticians can guide how to adjust parameters and how to achieve desired outcomes.
Development of analytical assays: Companies involved in biotechnology and biopharma use a variety of analytical instruments. These intricate processes require excellent statistical and analysis abilities, from PCR to flow cytometry.
Freelancers can assist with the following services:
- Creation of a protocol for a process
- Troubleshooting analytical methods
- Assisting with the creation of the flow cytometry protocol
- Protocols for IHC and data mining
- Choosing an antibody and creating a sequence
- Help with PCR procedures and research design
- Experts in the field
Biotech and pharmaceutical companies constantly seek new content and must retain a substantial volume of it. While getting the task done by a dependable specialist, hiring freelancers might help you save money and time.
Consultants in life sciences and the expert economy: This talent is easily accessible to companies looking for it thanks to the expanding pool of freelancing industry professionals and academic researchers.
Life science consultants can now be reached on demand thanks to changes in employment regulations and remote working. Organizations can save valuable time and money by consulting an expert immediately and creating a dependable team of go-to experts under one roof.
Consultants in Life Sciences provide end-to-end assistance for biotech services, from protocol creation to regulatory, preclinical, clinical, and commercialization services. They are highly skilled professionals with PhDs who can assist with biologics, scientific affairs, IP, clinical, regulatory, and medical affairs.
iPSCs, CRISPR, DNA sequencing, and other Nobel Prize-winning services can be assisted by consultants in the biological sciences. The life sciences consultants assist with product development, regulatory tactics, and biotech research.