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) We provide consulting on the development of biopharmaceuticals, in vitro diagnostics, and cell and gene therapy products. In relationship to quality assurance and regulatory affairs, we provide the following services:

 

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.



2) Superlative BioSciences Corp, in addition, provides the following life science 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.



3) In the area of laboratory services, Superlative BioSciences Corp is also looking to raise money from angel investors or from a VC fund in the area of vitro toxicology. 

Our in vitro toxicology services would be based on the use of human stem cells in tissue culture, and multicellular 3-D constructs of normal and compromised human tissue microenvironments.


High-throughput screens are also being developed to meet the needs of pharmaceutical and biopharmaceutical companies in the areas of target discovery, drug efficacy testing, and drug safety and toxicology.



 


 



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