BioScreen is staffed with experienced industry professionals in analytical chemistry, microbiology, quality assurance and clinical claims testing and support. BioScreen offers consulting services in each of these areas of expertise.
Most requested consulting for the following:
- Preservations issues: BioScreen can provide consulting for various formulations on choice of preservatives depending on the clients needs. Consulting may be requested for difficult to preserve products, country specific, and natural and organic claims. Other requests may be preservative free formulations and/or cost reduction issues. Consulting may be free for existing clients or for specific projects.
- Plant audits: BioScreen has many years of experience performing GMP audits for cosmetic, OTC drug, and FDA registered GMP manufacturing facilities. BioScreen also offers audits for manufacturing plants in China. Bradford Rope president of BioScreen has audited over 40 manufacturing plants in China for color cosmetics as well as OTC and various personal care items. Please inquire for a price quotation.
- Manufacturing validation: BioScreen offers laboratory validation, clean room validation and various process validation testing and consulting.
Total Quality Management
BioScreen Testing Services, Inc. is uniquely specialized to provide complete quality assurance consulting, testing and regulatory support to personal care marketing companies. BioScreen provides customized programs in quality assurance management to fit the needs of the client. Clients include manufacturers, marketers and retailers of a wide range of personal care and over-the-counter drug products.
BioScreen provides marketing companies with turnkey quality assurance programs for releasing their finished products. We can also perform trouble shooting services as well as manufacturer and vendor quality audits.
What is a quality management program?
BioScreen acts as the in-house quality assurance laboratory or management team for our clients. With a complete complement of technical personnel, laboratory facilities for Analytical Chemistry, Microbiology, Clinical testing and Claims support, as well as, regulatory consulting, BioScreen is unmatched in its ability to provide total quality services and support. Programs can be customized from turnkey management, cGMP plant and vendor auditing capabilities to finished product release testing. BioScreen also writes and implements quality assurance manuals and programs to meet client requirements.
Types of Services may include the following:
- Writing of Quality manual or SOP's for a company quality program: BioScreen provides writing and implementation of a company quality program or various parts of a program as determined by client needs.
- Analytical Chemistry: BioScreen offers comprehensive testing for active ingredients, preservatives, sunscreen actives, fragrances and various other cosmetic ingredients. We are also experts at trouble shooting when products do not meet expectations and involve regulatory issues or customer complaints.
- Comparative testing of Private Label/OTC Drugs & Cosmetics to Major Brands: All testing is performed under strict cGMP guidelines, for both retailers and manufacturers to compare private label brands to name brand products.
- Trouble Shooting: BioScreen has the knowledge and capability to execute forensic analysis to determine problems like microbial or chemical contamination, crystal formation and product separation. We also conduct tests to determine counterfeit products.
- Microbiological: Our testing encompasses the full spectrum of microbiology, including aerobic plate count, Antimicrobial effectiveness testing, and yeast and mold testing. Consultations are also available for preservative system choices; as well as, water system evaluation and microbiology trouble shooting.
- Shelf life , Package Compatibility and Physical Testing: Products may be tested for physical characteristics ranging from color to viscosity in order to determine conformity to specification. Fill heights and weights to insure that products meet all weights and measures regulations may be tested. Tests are conducted to determine the durability of packaging under simulated aging conditions. Package/product compatibility. Shelf life of all products under stress and normal conditions is also performed.