Download - Drug Consulting
-
5/28/2018 Drug Consulting
1/2
WHAT
PACIFIC-LINK
PROVIDES
Pacific-Link offers comprehensive consulting
for development of medicinal products to
clients in the United States, Japan and Europe.Our company structure and consortium
approach allows us to place senior level
consultants on your project with low
overhead and costs to the clients.
CRF
DSMB/DMB
SOP
CMC 2
eCTD
PSUR
Strategic Drug DevelopmentConceptual design of Core Data Sheets and Target Labeling designed to maximize market potential
Designofdevelopmentprogramstogain approvalin targetindicationsand meet key company milestones
Strategiestomeet GlobalRegulatoryrequirements,whileacceleratingdrug developmentprograms
Critical Path Assessment
Orphan Drug strategies and applications
Fast-Track Approval strategies
Health Authority meeting packages and preparationDesign of Regulatory department systems, resources and structure
Clinical DevelopmentClinical protocol development, preparation (ICH format) and review
Statistical Analysis Plan preparation and review
Case Report Form (CRF) development
Study Procedure GuidelinesFormationandmanagementofDataSafetyMonitoringBoards(DSMB/DMB)
Investigational Brochure preparation and reviewStandard Operating Procedures (SOPs)
Regulatory SubmissionsRegulatory Strategy Development and Consultation
Medical and Technical writing for reg. submissions
(e.g. CSRs, CMC Sections, Module 2 Summaries)Preparation of eCTD applications for submission to Health Authorities
Health Authority Meeting packages, preparation and conduct
HealthAuthorityrepresentationanddirectnegotiationservices (US and EU Legal Representation Services)
Annual Report preparation and filing
Safety monitoring and reporting (e.g. SAE reporting, PSURs)
Pharmaceutical DevelopmentFormulation and process evaluation
Manufacturingcontractor evaluations andpre-quali fication audits
Small molecule synthesis to macromolecule bio-processing
Experiencedwith solidoral dosageforms,solutions,injectables, suspensions, aerosols,andtransdermalproducts
Analytical and Bioanalytical method development and review
Validation plansIQ/OQ of equipment
Standard Operating Procedures (SOPs)
Medical WritingPreparation of Clinical ProtocolsWriting of Clinical Study Reports
Investigational BrochuresInformed Consents
CRFsandSiteSpecificProcedures
IND documents and CTD
Scientific Publications
Slide Presentations
IQ/OQ
SOP
CRF
CD
8195 Run of the Knolls CTSan Diego, CA 92127Phone: +1-858-335-1300Fax: +1-858-769-0288Contact: [email protected]
162-0828
8-903Contact: [email protected]
www.pacificlinkconsulting.com
Pacific Link Consulting
US Office8195 Run of the Knolls CTSan Diego, CA 92127Phone: +1-858-335-1300Fax: +1-858-769-0288Contact: [email protected]
Tokyo Office8-903 Fukuromachi, Shinjuku-ku
Tokyo 162-0828Contact: [email protected]
www.pacificlinkconsulting.com
-
5/28/2018 Drug Consulting
2/2
WHAT
PACIFIC-LINK
PROVIDES
Pacific-Link offers comprehensive consulting
for development of medicinal products to
clients in the United States, Japan and Europe.Our company structure and consortium
approach allows us to place senior level
consultants on your project with low
overhead and costs to the clients.
CRF
DSMB/DMB
SOP
CMC 2
eCTD
PSUR
Strategic Drug DevelopmentConceptual design of Core Data Sheets and Target Labeling designed to maximize market potential
Designofdevelopmentprogramstogain approvalin targetindicationsand meet key company milestones
Strategiestomeet GlobalRegulatoryrequirements,whileacceleratingdrug developmentprograms
Critical Path Assessment
Orphan Drug strategies and applications
Fast-Track Approval strategies
Health Authority meeting packages and preparation
Design of Regulatory department systems, resources and structure
Clinical DevelopmentClinical protocol development, preparation (ICH format) and review
Statistical Analysis Plan preparation and review
Case Report Form (CRF) development
Study Procedure Guidelines
FormationandmanagementofDataSafetyMonitoringBoards(DSMB/DMB)Investigational Brochure preparation and review
Standard Operating Procedures (SOPs)
Regulatory SubmissionsRegulatory Strategy Development and Consultation
Medical and Technical writing for reg. submissions (e.g. CSRs, CMC Sections, Module 2 Summaries)
Preparation of eCTD applications for submission to Health Authorities
Health Authority Meeting packages, preparation and conductHealthAuthorityrepresentationanddirectnegotiationservices (US and EU Legal Representation Services)
Annual Report preparation and filing
Safety monitoring and reporting (e.g. SAE reporting, PSURs)
Pharmaceutical DevelopmentFormulation and process evaluation
Manufacturingcontractor evaluations andpre -qualification audits
Small molecule synthesis to macromolecule bio-processing
Experiencedwith solidoraldosage forms,solutions,injectables, suspensions, aerosols,and transdermalproducts
Analytical and Bioanalytical method development and reviewValidation plans
IQ/OQ of equipmentStandard Operating Procedures (SOPs)
Medical WritingPreparation of Clinical Protocols
Writing of Clinical Study Reports
Investigational BrochuresInformed ConsentsCRFsandSiteSpecificProcedures
IND documents and CTD
Scientific Publications
Slide Presentations
IQ/OQ
SOP
CRF
CD
8195 Run of the Knolls CTSan Diego, CA 92127Phone: +1-858-335-1300Fax: +1-858-769-0288Contact: [email protected]
162-0828
8-903Contact: [email protected]
www.pacificlinkconsulting.com
Pacific Link Consulting
US Office8195 Run of the Knolls CTSan Diego, CA 92127Phone: +1-858-335-1300Fax: +1-858-769-0288Contact: [email protected]
Tokyo Office8-903 Fukuromachi, Shinjuku-ku
Tokyo 162-0828Contact: [email protected]
www.pacificlinkconsulting.com
