Specific Regulatory Capabilities:
* Oversee, and ensure, on-time and high quality submissions for IND's, IMPD's, CTA's, NDA's, and BLA's.
* Provide strategic regulatory input to CMC teams to help ensure CMC activities align with anticipated regulatory expectations.
* Lead/Support preparation for Health Authority CMC meetings, and development of information packages.
* Lead communication between CMC and Regulatory affairs as working teams.
* Ensure alignment of company regulatory strategies with relevant Health Authority requirements.
* Proactively develop and lead internal cross-functional relationships between Regulatory Affairs, Regulatory Strategy, CMC Development, and Quality.
* Develop and implement best practices company-wide, combining relevant current and emerging trends in Regulatory, as well as tracking and communicating current Health Authority guidance and regulations.
* Coordinate regulatory activities across multiple sites as needed.
MedScope Process Development & Clinical/Commercial Operations
MedScope.com is highly focused on strategic regulatory strategy and sciences, and can quickly incorporate these skills to provide effective leadership in rapidly developing state-of-the-art QbD manufacturing technologies, with core experties in continuously manufactured products with integreated PAT feedback and feedforward controls. Additionally MedScope can lead process development utilizing both single use and stainless use components. Additionally, MedScope has substantial commercialization expertise, and can help quickly scale QbD documentation (protocols, BPR, specs, test methods, equipment qualification, reulatory control strategies, technology transfers, equipment acquisition and qualification, PPQ, etc.), and complete successful PAI and launch. Additionally, 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 can oversee both small and large scale remote outsourcing at favored contract manufacturing facilities. 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 cGMP CDMO Operations
MedScope.com 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 oversee and/or implement custom CDMO closed system DOE/Clinical/Manufacturing trials.
Analytical Development/Process Analytics
MedScope.com 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).
Manufacturing and ComOps
MedScope.com can oversee outsourced enterprise manufacturing operations, 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.
Facilities
MedScope.com can help your company rapidly scaling -up,-out, state of the art (Continuous, SU, PAT, Closed) cGMP manufacturing facilities for the production of biologics (Lenti, AAV, Monoclonal and Bispecific Antibodies, Fusion Proteins, Monoclonal Antibodies (via either Myeloma-Mouse B Cell, or Lenti-CHO Transfection)). MedScope has a strong biologics facilities expertise, as well as deep experience in hosting FDA Site Inspections.
Quality and Documentation
MedScope.com is highly 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.
Sales & Marketing
Please contact MedScope for further information.
Political Advocacy
MedScope.com is an active political advocate enterprise integrating the many new medical technologies with political advocacy groups.
Computational Nucleotide/Polypeptide Modelling
Please contact MedScope for further information.
How To Reach Us
MedScope.com 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 info@medscope.com.
