cGMP Commercialization Services
MedScope is highly experienced in all aspects of cGMP commercialization, and can provide a wide range of commercialization services to progress your cGMP company, outlined below. MedScope has successfully manufactured over 1,500 cGMP batches, completed PAI, and successfully filed and launched 8 unique product lines. MedScope is a rapid development organization, and in most instances can initiate value-based discussions within 24 hours. Please contact us at 802-236-8650 or firstname.lastname@example.org.
Commercial Operations - Platform
Commercialization starts with a solid commercial operations platform and plan. MedScope has substantial experienced in all aspect of cGMP operations, and can help structure or run your company consistent with that need. From a platform perspective, departments should be structured (Analytical, BizDev, Clinical/Med Affairs, Defense, Documentation, Equipment/Facilities, Environmental/Safety, Finance, Government Relations, Labeling, Legal(IP/Contracts/Business/Employees), Manufacturing, Materials/Purchasing, Quality Assurance, Quality Control, Regulatory) to codify key skill sets to exist within specific platform deparments as outlined above.
Commercial Operations - Cross Functional Plan
From a planning perspective, cross-functional teams from a variety of platform departments need to be continually tasked to acheive specific goals with specific timelines in order to achieve a truly cross functional integrated team empowered for success. MedScope is highly skilled at organizing cross functional teams to accomplish the myriad of complex tasks necessary to develop and launch cGMP commercial products.
Test method development and validation. Test equipment procurement, installation, development, IQ/OQ/PQ, problem solving and regulatory responses. MedScope can review and/or provide a wide range of comprehensive range of high-quality analytical assays to characterize protein therapeutics. Whether characterizing the original or subsequent reference standards, evaluating production lots to those standards or performing comparability studies of biosimilars or biobetters, we have the full-range of methodologies available to provide the detailed analysis required to pass scientific and worldwide regulatory standards. Areas of supporting expertise include Lenti (Using HEK293T Cells), and AAV Vectors, Viral Clearance/Inactivation, Assay /Bioassay Development, Protein Characterization, and Cell Line Characterization. Technical and regulatory expertise inlcude virology, molecular biology, cell biology, in-life and microbiology labs to provide high-quality and comprehensive CLC services. ICH and NMPA (previously CFDA) guidelines. The methods we work with are harmonized with global standards (e.g. ICH, EP, USP, JP, CN).
MedScope is a state of the art company in gene therapy, CAR T cell therapy, monoclonal antibody development and biosimilars, Lenti vector development, and small molecule development. MedScope can evaluate and guide your business needs to strategize, derisk, and anticipate best commercialization paths forward.
Clinical Development/Clinical Operations/Medical Affairs
MedScope has substantial experience in medicinal development, and can provide medical affairs/clinical development support, with broad experience in multiple disease states, and across multiple international filing strategies including break through products, rare disease products, and pediatric opportunities.
For more information, please contact MedScope at 802-236-8650 or email@example.com.
MedScope has broad experience in all aspects of cGMP documentation, including BPR, production protocols, production sampling protocols, production forms, product specifications, revision tracking, revision history, issuance of at-line log and tracking books, revision tracking of regulatory filings.
MedScope is knowledgeable of core cGMP environmentla and safety aspects of biopharmaceutical manufacturing, espeically in regards to the complex issues of controlling air flows, particle count, cleanliness, and water quality as applied to cGMP manufacturing and patient safety.
MedScope has substantial experience in all aspects of equipment and facility cGMP. Equipment capabilities include establishment of user requirements, vendor audits, facility requirements, evaluation of equipment performance capabilities, equipment surface and surface cleaning, establishment of log books, creation of cGMP training modules, budgetting, costing, negotiation and acquisition, equipment finance planning, budgetary controls, process/equipment trial runs and reports, facility preparation and equipment installation qualification, operational qualification, performance qualification, facility integration, log books, equipment process validation.
MedScope is experienced in financial accounting as applied to the biotechnology industry, in which COGS and CAPEX and HeadCount and Medical Labelling and Unique Market Launch Opportunities must be equally balanced and derisked against the many and substantial uncertainties of worldwide Legal and Regulatory bodies.
Political advocacy and thought leadership in rapidly evolving biologics and medicinal space.
MedScope can help coordinate production of in sourced and outsourced manufactured product labelling, cGMP compliant.
MedScope can provide consultation services, particularly in the area of patent strategic development, and business Quality Technical Agreements (QTA, which can optionally be developed in parallel with technology transfers).
Manufacturing, Operatrions, and outsourcing(and related cGMP tech transfer issues) are all core functions of MedScope. With the rapid rise in cGMP biotechnologies, PAT, and process automation, it is imperative for successful companies to quickly adapt new manufacturing capabilities. A unique aspect of this is the ability to rapidly tech transfer cGMP unit operations in order to quickly capitalize on new technologies, as well as to be able to manufacture product targeted to various regulatory bodies worldwide. Core to this is tech transfer via scale up, scale down, scale out, and scale in. To be successful companies need to be nimble and from day 1 be able to articulate and create batch records that embrace QBD right from the start. MedScope is highly evolved with this ability, and can quickly help your company acheive success in this area.
Additionally, MedScope has access to over 150,000 ft2 of fully enclosed enterprise manufacturing open space, and can quickly scale out closes system modules sith SU support to suit your manufacturing needs. This capability is supported by an entire cGMP suite of SOP's, BPR's, Protocols, Training Modules, Equipment Qualification Protocols, and Quality Event Tracking. MedScope also partners with several partners in order to provide a wide range of cGMP test services including Immunoassays(ELISA: high throughput to determine antibody specificity/sensitivity to target antigens), Western Blotting, Multiplexed Bead-based Assays), Stability Indicating Assays(SE-HPLC, IEX-HPLC or cIEF, CE-SDS, and Potency Assays), Chromatography(Protein G, Size Exclusion), etc.
MedScope can help with your materials and purchasing needs. Whether you are seeking a professional site audit, tech transfer to in source or outsource a manufacturing step(s), development a more complex quality technical agreement, possibly across different regulatory bodies, MedScope can help.
MedScope is well connected politically, and can assist developing strategies to influence and inform key decision makers in public policies.
Process Development & Clinical/Commercial Operations
MedScope is a leader in developing state-of-the-art manufacturing tecchnologies, and we have successfully lead development and launch of numerous QbD products, including continuously manufactured products with integreated PAT feedback and feedforward controls, using both single use and stainless components. Additionally, MedScope has substantial commercialization expertise, and over the years has lead manufacturing development of over 1,000 cGMP batches (inlcuding QbD documentation protocols, BPR, specs, test methods, equipment qualification, reulatory control strategies, technology transfers, equipment acquisition and qualification, PPQ), and completed successful PAI and launch of 9 commercial product lines. MedScope has strong competency in Quality and Regulatory Sciences, and can rapidly aid in development, filing, and interaction with various regulatory bodies worldwide. Additionally, MedScope has over 150,000 ft2 in open manufacturing space that can quickly be converted to ISO7 space for closed cGMP manufacture in partnership with the customer. Last, MedScope has core worldwide capabilities in Medical Affairs and Clinical Development (including Rare Disease, Pediatric Exclusions, Breakthrough Therapies), throughout all stages of development and commercialization. MedScope is also recoginized for core strengths in Medicine, with substantial clinical development experience in rare disease, pediatrics, and breakthrough therapy.
MedScope has successfully cGMP manufactured over 1,500 batches of complex medical products across multiple technologies and product lines, from initial development, Phase I to Phase III, scale, and launch, and as such has successfully developed succesful robust quality strategies to ensure safe manufacture and sale of robust medical product. MedScope is highly evolved in quality event management, risk assessment and risk management, quality line sign offs, CAPA, and event closure. With this knowledge MedScope is able to provide high quality operations to all cGMP manufactured product.
MedScope is highly also experienced in developing cGMP documentation, including BPR's, Protocols, Forms, SOP's, Qualification Documents, Tech Transfer Reports, etc. More importantly, MedScope has tremendous experience integrating Quality Operations plant-wide with Regulatory, Development, Manufacturing, QC & Analytical, and Sales and Marketing. MedScope can also provide site regulatory/quality audits, facilities inspections, audit pre-approval inspections (PAI), as well as new cGMP equipment (both test and manufacturing) acquisition and qualification.
MedScope is a sophisticated leader in managment of existing testing technologies, as well as development of novel state-of-the-art test technologies, from ddPCR to a wide variety of cell sorting technologies to use of a variety of mass spec test technologies, MedScope can help identify test sites as well as develop a wide variety of test and release methods. From a cGMP documentation perspective,
MedScope excels at providing rapid, intuitive Regulatory expertise, particulary in the process sciences and in particular in the Lenti/AAV, and Monoclonal Antibody Space (including Biosmilars). Whether you are seeking pre-IND support, Phase II/III Support, Biosimilar Support, MedScope can quickly help develop core cGMP control strategies, Development Reports, etc., as well as strategize regulatory planing in order to balance development and regulatory risk with clinical risk.
cGMP CDMO Operations
MedScope operates by development phase(pre clinical, IND enabling, clinical development, commercial), by service(process development, analytical, manufacturing CMC, facilities and site audits, regulatory scienes, quality, medcial affairs, sales and marketing, political advocacy, computational biology), and by disease(oncology, immunology, immuno-oncology, infectious disease). MedScope is a fully functional cGMP operation, and can quickly can review and/or implement custom CDMO closed system DOE/Clinical/Manufacturing trials. Please call for further details.
Sales & Marketing
MedScope is an active political advocate integrating the many new medical technologies with political advocacy groups.
Computational Nucleotide/Polypeptide Modelling
Contact MedScope to learn how we can assist your with a wide variety of software technologies.
How To Reach Us
MedScope is a rapid development organization, and in most instances can initiate and address a wide range of value-based discussions within 24 hours. Our teams and wide technological network in the biopharmaceutical industry enables us to quickly bring substantial knowledge and problem solving skills to help you quickly solve problems. For rapid response, please contact us at 802-236-8650 or firstname.lastname@example.org.