top of page

Pharmaceutical

GCP Services

As we aim to grow and expand, so does the variety of services provided via our Preferred Partnership.  We work in partnership with CROs and third-party vendors to offer various GCP services which can help clients across the globe, ranging from audits to monitoring services. We provide comprehensive GCP Quality Compliance services to the pharmaceutical industry.

Our GCP consulting services are characterized by:

  • Knowledge: We keep abreast of changing regulatory landscape and various regulatory requirements across the globe.

  • Experience: Qualified and experienced GCP auditors.

  • Experienced team with strong Project Management

  • Value: Our auditors/monitors are competent and efficient, producing results as quickly as possible.

  • Speed: Time is crucial when study execution/quality issues arise. We mobilize quickly to assist our GCP clients across the globe.

  • Solution-oriented approach: We can provide cost-effective solutions such as audit partnerships to support clients in meeting their regulatory requirements.

Our GCP services include:

AUDITS

  • The success of any clinical trial project depends on assuring that the data collected are of good quality. A well-organized system audit will point out potential problem areas early so that the solutions can be found before it is too late. This can be ensured by various types of audits.

  • Due to the increasing complexity of clinical trials and regulatory scrutiny, the components of a site audit program and the approaches taken towards designing and managing audits are constantly evolving. Our team of Auditors have extensive experience to accomplish the objective of the audit.

 

  • Clinical Research Organization Audits

  • System & Facility Audit

  • GAP Audit

  • For-cause Investigation

  • Site Qualification Audit

  • Regulatory Compliance Audit

  • Pre-clinical facility

  • Hospital site and/or Phase I facility

  • Computer system validation

  • Central Pharmacy and/or Supply Chain Warehouse

  • Center Pathology Lab

  • Archival Facility

BIOANALYTICAL PHASE

In-process Bioanalytical Monitoring (IPBA)

We ensure compliance in the following key areas during the sample analysis.

 

  • Accuracy during the analysis

  • Error-free stock weighing, CC/QC and Solution Preparation

  • Spiking, storage and accountability of CC/QC

  • Sample Processing as per Method SOP

  • Study Samples Accountability during receipt and storage

  • Calibration status of instruments before use

 

·Retrospective Bioanalytical Monitoring (RTBA)We review the following for compliance once sample analysis is over.
  • All the Raw data checks, samples review

  • Instrumentation Review

  • All study data review including draft Bioanalytical Report review.

  • Draft BA report verification against all the raw data

 

Method Development and Validation (MD/MV)

We ensure the following key areas during Method Development / Validation.

 

  • MD is done with enough trials to come to a conclusion.

  • Right interference and inference are drawn from the developed method.

  • The method is validated as per regulatory requirements without missing any critical experiments.

  • The method is robust enough to avoid any issues in study sample analysis.

MONITORING-CLINICAL PHASE

We offer high-quality monitoring services to manage a trial on time and on budget.

  • We work with our partners in many countries for clinical monitoring services. Our teams have local knowledge, so they understand the nuances involved in each market, from regulatory differences to cultural sensitivities.

  • We initiate projects quickly, with teams primed and ready to push the process through.

  • In Addition, our partners have several medical monitors who are highly experienced in the industry for subject-related matters eg. Cardiology, Oncology, Gastroenterology, Psychology etc.

  • Our expert team ensures the integrity of the study, adherence to protocol, quality of measurements, the safety of Subjects, the collection of valid data, and applicable regulatory requirements.

Types of Monitoring Services and Scope

  • With partners in many countries, our local teams have monitoring experience. They understand the nuances involved in each market, from regulatory differences to cultural sensitivities.

  • We initiate projects quickly, with teams primed and ready to push the process through.

  • In Addition, our teams comprise of several medical monitors who are key opinion leaders eg. Cardiology, Oncology, Gastroenterology, Psychology etc.

  • Site Initiation Visit (SIV)

  • Site Monitoring Visit (SMV)

  • Site Close-Out Visit (SCOV)

  • Retrospective monitoring visit (RMV)

PK-STATS MONITORING

Pharmacokinetics and Statistical monitoring is a new concept in clinical research. We offer online and retrospective PK-Stat monitoring. Our experts can add value to reporting quality and accuracy.

PROJECT MANAGEMENT

Our Project Managers provide leadership and oversight to our study teams and serve as a single point of contact for our sponsors. They have extensive experience in clinical research, leveraging their therapeutic focus and experience to coordinate complex clinical trials. We believe that timelines and critical milestones are met through focus, priority, and relevant experience. Our services include

  • CRO / Site Identification

  • Budget and Timeline Tracking

  • Study Design Support

  • Study Documents Review

  • Control Correspondence

  • Feasibility Studies

  • Audit Queries

  • Overall Global Clinical Trial Management

  • Study-Specific Management Plans

  • Vendor Management

  • Risk Mitigation & Ongoing Assessment

GMP SERVICES

We have a team of experienced professionals who have hands-on experience offering various GMP services which can help clients across the globe, ranging from audits to various consulting services.

We provide the following comprehensive GMP Quality Compliance services to the pharmaceutical industry.

  • Audits

  • Audit Reports

  • Compliance and Upgradation

  • GMP Consulting

GMP AUDITS

We cover a wide range of audits starting from Vendor Qualification to For-Cause investigation.

Types of Audit services include:
  • QMS Audit: Review in view of compliance and efficiency

  • Root Cause Audit: to investigate a process/Lab failure and CAPA

  • GAP Audit: Checking of all GMP systems, QMS, Infrastructure, Resources

  • Vendor Audit: Vendor Qualification or Re-qualification Audit

  • Pre-inspection GAP/Mock Audit: Just before Inspections are scheduled.

  • Sponsored Audits: Audit done on behalf of Sponsor.

 

Audit reports:

Independent GMP Audit Program (IGAP): We frequently perform GMP audits at various supplier sites across the globe to ensure GMP compliance.

We carry out various audits including full Site audits which focus on the facility’s quality management systems and cover a large number of products (API and Intermediates).

  • The GMP audits are conducted by our qualified and experienced auditors.  With the permission of the supplier, we add the IGAP report to our report library.

  • By purchasing our IGAP reports from the library, our clients only spend a small fraction of the costs usually associated with conducting a supplier audit.

  • With this huge experience, you can rely on us to draw complex compliance issues to a conclusion.

  • Our commissioned audits and audit partnership services can minimize the cost of the audit and ensure that our clients receive personalized reports with areas most relevant to their operations.

COMPLIANCE AND UPGRADATION

We provide GMP Upgradation services in compliance with the guidelines USFDA, EMA, WHO, and PICS.

We provide an integrated solution for GMP Compliance & Upgradation tailored to your needs at low costs in a time-efficient manner by:

 

  • Establishing GMP Management Systems

  • Performing the Gap Analysis

  • Planning Activity as per Guidelines

  • Guidance in Implementation & Documentation

  • Training Activities for Executives

  • Conducting Internal Audits

GLPServices

We partner with the GLP labs who offer a comprehensive range of preclinical services to the various leading Generics, Pharmaceuticals and Biotech companies in line with domestic/ global regulatory requirements. Our partners’ teams are professional, highly trained and devoted individuals committed to the success of every client.

Our expert partners support preclinical phase of the drug development in following areas:

  • Toxicity Studies

  • Acute Toxicity

  •  Developmental and Reproductive Toxicity

  •  Repeated Dose Toxicity

  • Mutagenicity Studies of Bacterial Reverse Mutation (AMES) Test

  • Chromosomal Aberration Test (in vitro)

  •  Micronucleus Test (in vitro) o Micronucleus Test (in vivo) 

  •  Analytical and Clinical Chemistry Testing

  •  Other Analytical and Bioanalytical Method Validation Studies

  • Bioanalysis o Dose Formulation Analysis

  • Drug Metabolism & Pharmacokinetic (DMPK)

  •  Safety Pharmacology

  •  Tissue Distribution o

  •  Toxicokinetic Studies.

Our expert partners have conducted numerous preclinical toxicology and efficacy studies on potential therapeutic agents and other chemicals in line with the requirements of GLP as per OECD, ICH and FDA guidelines.

bottom of page