LNH Pharma A Trusted Partner

ABOUT US LNH Pharma is a Global pharma services company , provide a broad range of clinical research services for clinical and generic product development for Pharma/Biotech industries for introducing generic and new drug products. LNH Pharma Mission: To deliver value added , reliable and cost effective services for the clients. Vision: To be an integrated services company with global distinction , aiming for long term partnership with clients Values: Quality, Integrity, commitment and accountability.

Organization Structure CEO COO HR Executives BD

System & Procedures The LNH Pharma has quality procedures in place for services being performed . All the procedures are established as per different regulatory and study specific requirements. All the procedures are being updated as when required or on regular basis as per the changes in regulatory norms and guidelines. The procedures are being prepared and updated as per the Client specific requirements for meeting study requirements within the quality management system.

OUR PEOPLE Dr. Vasu.Kandati, M.Pharm(Pharmacology) , Ph.D COO Mr.Tiruvendra.S BD-Director Advisors: Prasad.CH, Clinical Trial Specialist Srinivasa Rao Pathuri, Formulation Specialist Dr.Varaprasda, Bioanalytical Specialist

LNH Pharma Services

PROJECT MANAGEMENT BA/BE TRIALS: Checking CRO feasibility for slots and study requirements. Identification, selection and Qualification of CROs. Protocol review and Finalization as per Regulatory requirements. Coordinating with CROs for BENOC &T-License , Protocol approval By Ethics committee and DCG(I) Coordinating with sponsor & CROs for IP management as per the Regulatory requirements.

Monitoring of CLINICAL STUDY EXECUTION PROJECT MANAGEMENT Monitoring of CLINICAL STUDY EXECUTION Check-in process Dispensing Dosing Phlebotomy activities Check out process Ensuring storage and retention quantity of IPs for regulatory inspections with CROs.

PROJECT MANAGEMENT Monitoring of BIOANALYTICAL STUDY EXECUTION METHOD VALIDATION includes monitoring of processing for P&A batches, Extended P&A batch, Stabilities and Matrix effect. PROJECT SAMPLE ANALYSIS includes monitoring of processing or regular analysis, Repeat analysis, Individual repeats and Incurred sample reanalysis.

PROJECT MANAGEMENT AUDIT AND COMPLIANCE Perform retrospective audit of Clinical data includes review of Medical screening records, Case Report Forms, Logbooks and essential documents in trial master file. Perform review of Clinical study report and SDTM data as per CDISCO requirements. Perform retrospective audit of Method validation data includes Method validation trial documents, MV Chromatograms, Audit trials, Logbooks and Method Validation report.

PROJECT MANAGEMENT AUDIT AND COMPLIANCE Perform retrospective audit of project sample analysis data includes Sample analysis trial documents, Chromatograms, Repeat Analysis documents, Incurred sample analysis, Audit trails, Logbooks and BA report. Review of e-CTD report with STDM format as per CDISCO requirements.

PROJECT MANAGEMENT CLINICAL TRIALS Site identification and Qualification Site initiation Budget and contract negotiation Regulatory document preparation and collection Investigator meeting planning and presentation Site personnel training Interim site monitoring visits

PROJECT MANAGEMENT CLINICAL TRIALS Site closure Clinical study material retention, storage and accountability as per regulatory requirements. Monitoring of Bioanalytical study execution includes method validation and project sample analysis Handling of regulatory queries and coordinating for regulatory inspections.

PROJECT MANAGEMENT CLINICAL TRIALS: Audit and Compliance Review of patient records, source data, Paper CRFs, e-CRFs, essential documents in SMF&TMF. Review of Clinical study report including Annexures as per CDISCO requirements. Review of Bioanalytical data ,Validation data and BA report as per the protocol and study requirements.

MONITORING BA/BE TRIALS: Food effect studies and Fasting studies Multiple dose studies Dose escalation studies Drug-Drug interaction studies Special population studies like post -menopausal and psychiatric studies

MONITORING BA/BE TRIALS : BE studies with special requirements like cardiac monitoring. BE trials for all major therapeutic areas

MONITORING CLINICAL TRIALS: Patient population PK studies (Patient BE studies) Patient population PD studies (Clinical end point studies) Clinical trials including Phase1, Phase 11-A,11-B and Phase111 for all major therapeutic areas.

REGULATORY QUERIES Response for Product and Facility based inspections for different health regulatory authorities (But not limited) including USFDA, EMEA, UK-MHRA, MCC, ANVISA, Health Canada, DCG (I), MoH-Malaysia, MoH-Turkey, Rest of the world and other regulatories. Dossiers for BE-NOC/CT-NOC,T-License and Facility approvals like DCG (I), MoH-Turkey, MoH-Malaysia, GCC and ANVISA. Regulatory consultancy for clinical trial and BA/BE trials.

CRO AND INVESTIGATIONAL SITE ESTABLISHMENT Support and Guide the sponsors /Hospitals/Investigators for establishing CRO and Investigator site as per regulatory requirements. Design the systems, process, procedures and facility as per the different regulatory requirements and Client need. Review and support for Qualification and validation of instruments/equipments.

CRO AND INVESTIGATIONAL SITE QUALIFICATION Qualify CRO and Investigator sites in India and Abroad for the national and international clients as per the regulatory and study requirements. Prepare the CRO and investigational site before hand for the product and facility based inspections as per different regulatory and study requirements.

AUDIT AND COMPLIANCE Perform the retrospective audit of clinical data including Medical screening records, Case Report Forms and Trial Master file essential documents. Review of Clinical study report as per CDISCO requirements. Perform retrospective audit of method validation data including Method validation trial documents, MV Chromatograms, Audit trials, Logbooks and Method Validation report.

AUDIT AND COMPLIANCE Perform retrospective audit of project sample analysis data including Sample analysis trial documents, Chromatograms, Repeat Analysis documents, Incurred sample analysis, Audit trials, Logbooks and BA report. Review of e-CTD report as per CDISCO requirements.

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