Superlative BioSciences Corporation

About Us


Our company provides superlative services to move your company's life sciences projects forward from conception to validation, through development, pass regulatory hurdles, and into the marketplace.
1) Superlative BioSciences Corporation is a Biological Services Company.
2) Superlative BioSciences Corporation provides consultation on:
The Preparation of Quality Manuals & Other Quality Documents including Change Control, Deviations, Trending, CAPA, Root Cause Analysis, Complaint Handling, Risk Management, FDA/GLP, FDA/GMP FDA/QSR, FDA/GTP, FDA/GCP, ICH, EMA, CE Marking & ISO Documents Management.
Preparation of SOPS, Master Batch Records (MBRs), Validation Plans & Reports, CMCs, INDs, BLAs, NDAs, 510K and PMA submissions.
3) In addition, Superlative BioSciences Corporation provides the following Life Sciences Business Services:
Technology EvaluationMarket ReportsPreparation of Business Plans Preparation of Marketing PlansWriting & Editing of Life Sciences Proposals, Reports, Books, Articles and Online Study Guides.
1) Superlative BioSciences Corporation is a Biological Services Company.
2) Superlative BioSciences Corporation provides consultation on:
The Preparation of Quality Manuals & Other Quality Documents including Change Control, Deviations, Trending, CAPA, Root Cause Analysis, Complaint Handling, Risk Management, FDA/GLP, FDA/GMP FDA/QSR, FDA/GTP, FDA/GCP, ICH, EMA, CE Marking & ISO Documents Management.
Preparation of SOPS, Master Batch Records (MBRs), Validation Plans & Reports, CMCs, INDs, BLAs, NDAs, 510K and PMA submissions.
3) In addition, Superlative BioSciences Corporation provides the following Life Sciences Business Services:
Technology EvaluationMarket ReportsPreparation of Business Plans Preparation of Marketing PlansWriting & Editing of Life Sciences Proposals, Reports, Books, Articles and Online Study Guides.


1) Superlative BioSciences Corp is a biological products development and services company that has an in-house biotechnology R&D program. We also provide consulting on the development of biopharmaceuticals, in vitro diagnostics, and cell and gene therapy products, particularly in relationship  to quality assurance and regulatory affairs issues.

 

2) In the area of life sciences services, we can set up for you multicellular 3-D constructs of normal and compromised human tissue microenvironments and combine this with high-throughput screening to meet the needs of pharmaceutical and biopharmaceutical companies in the areas of target discovery, drug efficacy testing, and drug safety and toxicology.

 

3) Our 3D tissue constructs can  also be viewed using virtual reality (VR) tools. For example, using VR, detailed examinations of human tissues by clinicians can be made, and disease progression or possible treatments determined based on these details. Patients themselves can also immerse themselves in the VR space and view the VR images using our tools. The system may also be used by pharmaceutical companies to conduct clinical trials and translate lab discoveries into real-life personal medicine applications using VR tools. 

 

4) Superlative BioSciences Corp is currently seeking to raise money from angel investors or from a VC fund for the validation and marketing of the company's services. See: https://gust.com/companies/superlative-biosciences-corporation

 

5) Superlative BioSciences Corporation also provides consultation on:

Compliance to FDA, EU, and ICH GLP, GMP, QSR, GTP, GCP; Eligibility for FDA Regenerative Medicine Advanced Therapy (RMAT) Designation;

CE Marking Services; and ISO Documents Management.


This includes the Preparation of Quality Manuals & Other Quality Documents including Change Control, Deviations, Trending, CAPA, Root Cause Analysis, Complaint Handling, and Risk Management Plans. We also write SOPS, Master Batch Records (MBRs), Validation Plans & Reports.


We also prepare IRBs, Clinical Protocols, CMCs, INDs, BLAs, NDAs, 510Ks, PMAs documents and handle your company's FDA regulatory submissions.


6) In addition, Superlative BioSciences Corporation also provides the following Life Sciences Services:

Writing & Editing of Proposals including SBIR & STTR Grants; 

Conducting Market Research and Preparing Marketing Plans, Business Plans, Pitch Decks and Written & Recorded Presentations to Get Your Projects Funded.

Writing and Editing of Reports, Books, Articles and Online Study Guides.

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