IQ/OQ SOP

8195 Run of the Knolls CT San Diego, CA 92127 Phone: +1-858-335-1300 Fax: +1-858-769-0288 Contact: richard@pacificlinkconsulting.com 162-0828 8-903 Contact: sarina@pacificlinkconsulting.com

CRF DSMB/DMB SOP

CRF CD

CMC 2 eCTD PSUR

www.pacificlinkconsulting.com

Strategic Drug Development

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.

Conceptual design of Core Data Sheets and Target Labeling designed to maximize market potential Design of development programs to gain approval in target indications and meet key company milestones Strategies to meet Global Regulatory requirements, while accelerating drug development programs 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

Pharmaceutical Development

Formulation and process evaluation Manufacturing contractor evaluations and pre-qualification audits Small molecule synthesis to macromolecule bio-processing Experienced with solid oral dosage forms, solutions, injectables, suspensions, aerosols, and transdermal products Analytical and Bioanalytical method development and review Validation plans IQ/OQ of equipment Standard Operating Procedures (SOPs)

Medical Writing

Clinical Development

Clinical protocol development, preparation (ICH format) and review Statistical Analysis Plan preparation and review Case Report Form (CRF) development Study Procedure Guidelines Formation and management of Data Safety Monitoring Boards (DSMB/DMB) Investigational Brochure preparation and review Standard Operating Procedures (SOPs)

Preparation of Clinical Protocols Writing of Clinical Study Reports Investigational Brochures Informed Consents CRFs and Site Specific Procedures IND documents and CTD Scientific Publications Slide Presentations

Pacific Link Consulting

US Office 8195 Run of the Knolls CT San Diego, CA 92127 Phone: +1-858-335-1300 Fax: +1-858-769-0288 Contact: richard@pacificlinkconsulting.com Tokyo Office 8-903 Fukuromachi, Shinjuku-ku Tokyo 162-0828 Contact: sarina@pacificlinkconsulting.com

Regulatory Submissions

Regulatory 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 Health Authority representation and direct negotiation services (US and EU Legal Representation Services) Annual Report preparation and filing Safety monitoring and reporting (e.g. SAE reporting, PSURs)

www.pacificlinkconsulting.com

8195 Run of the Knolls CT San Diego, CA 92127 Phone: +1-858-335-1300 Fax: +1-858-769-0288 Contact: richard@pacificlinkconsulting.com 162-0828 8-903 Contact: sarina@pacificlinkconsulting.com

IQ/OQ SOP

CRF DSMB/DMB SOP

CRF CD

CMC 2 eCTD PSUR

www.pacificlinkconsulting.com

Regulatory Submissions

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.

Regulatory 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 Health Authority representation and direct negotiation services (US and EU Legal Representation Services) Annual Report preparation and filing Safety monitoring and reporting (e.g. SAE reporting, PSURs)

Pharmaceutical Development Strategic Drug Development

Conceptual design of Core Data Sheets and Target Labeling designed to maximize market potential Design of development programs to gain approval in target indications and meet key company milestones Strategies to meet Global Regulatory requirements, while accelerating drug development programs 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

Formulation and process evaluation Manufacturing contractor evaluations and pre-qualification audits Small molecule synthesis to macromolecule bio-processing Experienced with solid oral dosage forms, solutions, injectables, suspensions, aerosols, and transdermal products Analytical and Bioanalytical method development and review Validation plans IQ/OQ of equipment Standard Operating Procedures (SOPs)

Pacific Link Consulting

US Office 8195 Run of the Knolls CT San Diego, CA 92127 Phone: +1-858-335-1300 Fax: +1-858-769-0288 Contact: richard@pacificlinkconsulting.com Tokyo Office 8-903 Fukuromachi, Shinjuku-ku Tokyo 162-0828 Contact: sarina@pacificlinkconsulting.com

Medical Writing

Clinical Development

Clinical protocol development, preparation (ICH format) and review Statistical Analysis Plan preparation and review Case Report Form (CRF) development Study Procedure Guidelines Formation and management of Data Safety Monitoring Boards (DSMB/DMB) Investigational Brochure preparation and review Standard Operating Procedures (SOPs)

Preparation of Clinical Protocols Writing of Clinical Study Reports Investigational Brochures Informed Consents CRFs and Site Specific Procedures IND documents and CTD Scientific Publications Slide Presentations

www.pacificlinkconsulting.com