cmcpluspharma.com
Ensuring Solid Submission for Small Pharma | CMCplusgeneva, support, consulting, CMC
http://www.cmcpluspharma.com/
geneva, support, consulting, CMC
http://www.cmcpluspharma.com/
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WHOIS PRIVACY PROTECTION SERVICE, INC.
WHOIS AGENT
PO ●●●639
C/O CMC●●●●●●●RMA.COM
KIR●●●AND , WA, 98083
US
View this contact
WHOIS PRIVACY PROTECTION SERVICE, INC.
WHOIS AGENT
PO ●●●639
C/O CMC●●●●●●●RMA.COM
KIR●●●AND , WA, 98083
US
View this contact
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Ensuring Solid Submission for Small Pharma | CMCplus | cmcpluspharma.com Reviews
https://cmcpluspharma.com
geneva, support, consulting, CMC
cmcpluspharma.com
Compliance and Quality Assurance | CMCplus
http://www.cmcpluspharma.com/compliance-and-quality.html
Small Pharma……Got Approval? Compliance and Quality Assurance. Development of policies, work instructions and specifications to meet GMP requirements, including the latest FDA, Pharmacopeia and EMA guidelines. Change control, deviations, CAPAs and OOS. GMP documentation, including master production records, batch records, testing records, stability protocols and reports, and SOPs. Response and support for supplier compliance issues. Method validation protocols and reports. GMP, IPEC, and ISO audits.
Drug Development and Strategy | CMCplus
http://www.cmcpluspharma.com/drug-development-and-strate.html
Small Pharma……Got Approval? Drug Development and Strategy. For chemical synthesis and analytical development. From chemical development to manufacturing scale and supervision to ensure GMP compliance. Of appropriate analytical methods for purity, assay, genotoxic impurities. Of regulatory strategy and controls, generation of correct, accurate documentation following this strategy to be used for regulatory submission.
Outsourcing Management | CMCplus
http://www.cmcpluspharma.com/outsourcing-management.html
Small Pharma……Got Approval? Working with your CMO. Coordinating the various processes from one phase to another, meeting timelines and dealing with complex regulations are challenges faced during the drug discovery and development process. These challenges are even greater when working through an external partner for supply of API and medicinal products. We provide support for the following. Draft request for proposals, develop technical transfer packages, and lead or participate in preliminary meetings.
Analytical | CMCplus
http://www.cmcpluspharma.com/analytical.html
Small Pharma……Got Approval? Do You Know…. Phase I requirements and Regulatory Agencies expectations may actually differ? We can help you understand these differences and provide you with an analytical control strategy which provides accurate data, without compromising on time and costs. We can answer the. Do analytical methods need to be validated for Phase I clinical trial material (CTM)? What is a phase suitable validation strategy? When can limit tests be used? How to validate a limit test method?
CMC-Regulatory Affairs | CMCplus
http://www.cmcpluspharma.com/cmc-regulatory-affairs.html
Small Pharma……Got Approval? We perform due diligence for in and out licensing opportunities. We evaluate reports and documentation for regulatory compliance in the area of chemistry, manufacturing and controls and provide an expert review including but not limited to: key questions, gaps in the dossier, assessment of regulatory risk and strategy. Guiding you through the maze. Module 3 Quality and module 2.3 Quality Overall Summary. Type II DMFs, reactivations, amendments and annual reports.
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Ensuring Solid Submission for Small Pharma | CMCplus
Small Pharma……Got Approval? According to industry surveys, 1 out of 10 candidates that enter Clinical Phase I will obtain marketing authorization. The timeframe for this is between 7-11 years. Ensuring Solid Submission for Small Pharma. We relieve time and resource pressures, and above all we build compliance and quality into our client's programs. Compliance and Quality Assurance. Drug Development and Strategy.
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