Training:

We provide complete as well as customized trainings on:

• Standard Operating Procedures (SOPs)
• Good Clinical Practice (GCP) & Good Laboratory Practice (GLP)
• 21 CFR Part 11 training.
• Computer System Validation
• GCP auditing skills
• Regulatory Inspection Preparedness
• Quality Management System(QMS) Training
• Electronic Common Technical Document (eCTD) training

Audits:

We provide the following audit services:

• System and facility audit
• Investigator/Hospital Site audits
• GAP/Deficiency audit
• For cause -Investigation
• Site/CRO Qualification audit
• Regulatory compliance audit
• Sponsor audits
• GCP & GLP Audits
• QMS audits
• IEC/IRB Audits
• Regulatory Mock audits- Pre & Post Regulatory inspection
• Study/Trial Master Files audits
• Study documents (Protocol, Informed Consent, Clinical Study Reports) audits
• Clinical Databases audits
• Statistical Programming (Tables, Figures/Graphs and Listings) audits
• Third party vendors audits (including Clinical Pathology laboratories, CROs, CSVC, Central pharmacy/Drug depots,            Phase I Units, Bioequivalence/Bioavailability Units (including Bio-analytical labs), Translators and Archives.

Project Management:

We provide the following services to our Clients

• CRO/Site identification, selection and qualification
• Project Contract, Budgeting and timeline tracking
• Time management from protocol design to report submission
• Study design support and protocol review.
• Regulatory approvals – T License/BE NOC and DCGI Coordination.
• Study documents and Final report review
• Follow up visits and timely updation to Clients
• Responding to Regulatory deficiencies/queries
• Overall Study management
• Project initiation and in-study monitoring

Product Development Support:

We offer Pharmaceutical Companies to bring Clinical candidates through their pipeline faster and with greater efficiency, we provide expert pharmaceutical drug product development solutions.

From developing a fit-for-purpose formulation for pilot studies to scaling up for pivotal studies and ultimately commercialization, our pharmaceutical drug product development solutions are customized to meet your needs.

The experienced development team provides confidence that products will be developed to meet our customers' objectives. Our scientific expertise will ensure success by adding efficiency and manageability to your development program.

The following are the services we can offer:

• Biowaiver Justification
• Particle size selection
• Excipients selection
• Opinion on Qualitative and Quantitative composition
• Selection of Biorelevant media
• In Vitro Dissolution profiles evaluation
• Permeability studies support

API and Intermediates supply:

We expertise in offering molecules for both API and intermediates through our associated partners.

Medical Writing:

JSR Pharma Solutions offer Medical writing services to National and International pharma clients.

Pharmacovigilance:

JSR Pharma Solutions offer Pharmacovigilance services to National and International pharma clients.