Global Healthcare Solutions Provider Fleek Pharma

Fleek Pharma Pvt Ltd
“Commitment, Integrity & Quality”

“Commitment, Integrity and Quality”
“Fleek Pharma is a one stop global
organization that provides solutions for
you to move healthcare ahead making your
journey our mission.”

We strive to become your committed business partner in the
field of healthcare providing you with:
 Proprietary data and information analysis on customized clinical trials
 Developing Safety & Healthcare Databases
 Market Research
 Benchmark Reports
 Information Services

 Pharmacovigilance
 Expedited Reporting
 Aggregate Reporting
 Clinical Reporting
 Clinical Trials
 BA/BE
 Biosimilars
 Medical Writing and Review
 Medical Informatics
 Regulatory affairs
Services provided by Fleek Pharma:

Pharmacovigilance:
 Our Pharmacovigilance services helps discover, streamline, manage, and
reuse drug safety data across your safety and PV information lifecycle.
 Our partners may use the service to reduce operational cost and for
strategic risk management in areas such as:
 Monitoring social media, patient forums, and other web content to
discover and aggregate potential adverse events

Pharmacovigilance: Cont.
 Streamline case management processes by automating the coding of
adverse events, treatments, and medical history information from
patient case reports
 Link safety and PV data to other sources of pre-clinical, clinical, and
commercial data to support drug development, marketing, and sales
activities

Expedited Reporting: Trained and on Time
 Drug safety services: emphasis on the timely reporting of post-
authorisation case reports
 A fully validated E2B compliant safety database (Argus, ARISg)
 Highly effective SOPs and operating guidelines
 A constant quality management system with ‘on time’ reporting
 Registration and running electronic reporting systems such as
EudraVigilance
 EMEA trained employees ensure compliance

Aggregate Reporting: Compliant and Thorough
 A broader view of the safety profile of a drug
 Periodic Safety Update Report (PSUR) and Development safety
updated report (DSUR) apart from periodic adverse drug experience
report (PADER)
 Cost-effective way of reporting

Our post-marketing capabilities include:
 Global infrastructure and site relationships to scale up to deliver large
studies quickly and efficiently
 Integrated expertise in health outcomes, biostatistics, epidemiology
and post-marketing regulations
 Streamlined operations that reduce time and cost

Clinical Trials:
The range of services offered are:
 Early Patient Studies (Phase I, II, III & IV) across all therapeutic areas
 Clinical Trial Project Management and Monitoring
 Adaptive Trial Design
 Patient Recruitment Assistance
“We believe in providing on-time, on-budget, quality
deliverables!”

BA/BE Studies:
 Our clinical sites are registered with the national regulatory and
certification authorities of India like the CDSCO and DCGI
 Trials are run by qualified professionals
 High-quality results across all phases of drug development and
commercialization

Bioanalytical services:
The labs have expertise with many validated methods to quantitate all
types of compounds using LC/MS/MS, HPLC and immunochemistry.
Services include
 Comprehensive, state-of-the-art assay development
 Transfer, validation and sample analysis in multiple biological species
and matrices
 Metabolite identification

Biosimilars:
 A robust clinical and analytical data management system
 Biosimilar Assay Development & Testing
 Assistance with diverse set of methods to evaluate comparability of
both the biosimilar drug and its clinical performance
“We carry your project from Discovery phase through Phase III
studies and beyond.”

Medical Writing and Review:
Regulatory and Clinical Writing:
 ICH GCP compliant Clinical Study Reports (CSRs); Phases I to IV,
including CSR Synopses for public disclosure
 Study Protocols
 Clinical and non clinical sections of the Common Technical Document
(CTD) including summaries and overviews for EU and US Regulatory
Authorities
 Investigator Brochures
 Patient Safety Narratives

Medical Writing and Review: Cont.
Regulatory and Clinical Writing: Cont.
 Patient information including Informed Consent and Patient Brochures
 Pharmacovigilance documents such as Periodic Safety Update Reports
 Standard Operating Procedures (SOPs) covering all aspects of drug
development including the design, conduct and reporting of clinical
trials and the outsourcing of Sponsor responsibilities to a Clinical
Research Organization (CRO)

Scientific Communications:
 Conference materials (abstracts, poster presentations and slide sets)
 Manuscripts
 Editorial support
 Journal/conference submission
 Product website content (for both scientific and patient audiences)

Scientific Communications: Cont.
 Educational material for patients, healthcare professionals and
pharmaceutical industry personnel
 Medical marketing reviews and reports
 Literature reviews
 Publication planning
“Our writers take pride in presenting your scientific
results and content in accordance to your individual
publication plan and strategy.”

Regulatory Affairs:
Pharmaceutical Regulatory Affairs Services:
 Dossier/submission preparation or review and filing
 Pre-meeting packages, INDs/CTAs/IDEs and post-filing
submissions, BLA/NDA/NDS/MAA/510(k)/PMA filings (US, Canada,
EU)
 Submission preparation to other worldwide agencies in European
countries, South America, Australia, and Asia

Regulatory Affairs: Cont.
Development of regulatory strategy for the product’s life
cycle:
 Consideration of international regulatory requirements
 Meeting international filings
 Revision of plans as guidelines change

Regulatory Affairs: Cont.
Additional Services in Regulatory submissions:
 Liaison with regulatory agencies on regulatory, Chemistry,
Manufacturing and Controls (CMC), clinical and toxicology matters
 Respond to regulatory agency questions

Our Specialities:
Clinical Data Management:
 Protocol design & review
 Randomization schedules
 Case report form (CRF) design & review
 Database design
 Data entry
 Data validation / verification

Our Specialities:
Clinical Data Management: Cont.
 Data transfer
 Medical coding
 Quality management procedures
 Data manipulation
 EDC
“End-to-end clinical data management, analysis and
integration”

Our Specialities:
Statistical Consulting:
We help you define correct study components for optimal efficiency,
then follow through to ensure clinical results meet your goals.
 SPSS, Graph Pad In stat, SAS
 Data safety monitoring boards (DSMBs) reviews
 Set-up, charter, analysis plan development and maintenance of big
Clinical Data

Our Specialities:
Bioanalytical Services:
 Expanded state of the art assay development, transfer, validation and
sample analysis in multiple biological species and matrices, as well as
metabolite identification
 The labs have expertise with many validated methods to quantitate
all types of compounds using LC/MS/MS, HPLC and immunochemistry

“Our qualified experts can provide
consulting end-to-end regulatory solutions
ensuring compliance throughout the
product life cycle while helping to advance
global drug development.”

Contact Us
At Our Office:
Kolkata Office: 1/A, R.B.C. Road, Kolkata - 700 124, India
Ahmedabad Office: 6, K.B. Royal Alteza, Chandkheda,
Ahmedabad - 382 424, India
Email us: support@fleekpharma.com
Call us: +91- 98703 28552 / 96509 22724
Website: www.fleekpharma.com

Global Healthcare Solutions Provider Fleek Pharma

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