We can develop and deliver a complete auditing solution for you by implementing our Outsource QA program. Outsource QA allows you to maintain quality at your site, leveraging our QA team and systems, reducing total cost

We work with a variety of clients in bringing in expertise on a “need-basis”. We have worked with early stage CRO’s in building up their systems and teams. We have also worked with large established CRO’s in reviewing and assisting in documentation development.

 

GAP ANALYSIS

 

Vaatsalya Clinical has a team of highly experienced and knowledgeable consultants who can independently and objectively assess existing quality systems to identify gaps or deficiencies.  The Consultants provide valuable input into optimizing systems to ensure a high quality output. 

QUALITY MANAGEMENT CONSULTANCY

Companies performing clinical development internally are becoming increasingly concerned about whether their systems are working efficiently and are compliant with current regulatory requirements.  There have been many changes in clinical trials legislation over recent years which have increased the complexity of clinical development and commanded more resources.  One of the challenges companies face is being able to meet regulatory expectations with limited resources, whilst remaining competitive. The success of a clinical trial, or a positive outcome from a regulatory inspection, is dependent on the effectiveness of the quality system in place.

Vaatsalya Clinical has a team of highly experienced and knowledgeable consultants who can independently and objectively assess existing quality systems to identify gaps or deficiencies.  The Consultants provide valuable input into optimizing systems to ensure a high quality output. 

SOP WRITING

The first step in ensuring that studies are conducted appropriately is to have a well-written procedure which specifically outlines how each task should be performed.  Vaatsalya Clinical has the capability of writing customized Standard Operating Procedures (SOPs) for:

Study sites

Sponsors/CRO’s

IRB’s

Vaatsalya Clinical can also assist you in the review of your existing SOPs to determine if these comply with FDA regulations and FDA guidelines

SPONSOR/ MONITOR SOP’S

Preparation, Issue, and Revision of Standard Operating Procedures

Clinical Monitor Training

Selecting Investigators and Study Sites

Developing Informed Consent

Conducting Site Evaluation Visits

Conducting Study Initiation Visits

Conducting Periodic Site Visits

Reviewing Case Report Forms at the Study Site

Reviewing Regulatory Documents

Adverse Experiences, Serious Adverse Experiences, and IND Safety Reports

Managing Study-Specific Clinical Supplies

Close-Out Visits

Telephone Contact Reports

 

IRB/IEC SOP’S

IRB Responsibilities

IRB Membership and Training

IRB Meetings IRB Record Keeping

IRB Review of Research

IRB Review of the Informed Consent Document

IRB Review of Advertisements

IRB Review of Unscheduled Mandatory Reports

Criteria for Exempt and Expedited Review

 

INVESTIGATIONAL SITE SOP’S

Preparation, Issue, and Revision of Standard Operating Procedures

Training Study Site Clinical Research Staff

Assessing Protocol Feasibility

Investigator Agreements with Sponsors or Organizational Chart for the Study

Site Interaction with the IRB

Recruiting Study Subjects

Study Initiation and Implementation

Reviewing and Obtaining Informed Consent Adverse Experiences, Serious Adverse Experiences, and IND Safety Reports

Drug Storage and Accountability

Managing Biological Samples

Interactions with Sponsor/CRO

Study Files and Record Retention  

 

DUE DILIGENCE

We have the experience; the skills and the competencies to conduct independent due diligence of clinical research organizations (CRO) to help Venture Capital firms and Investors understand and manage the associated risks.

 

 

REGULATORY AFFAIRS

We engage with the Regulatory Affairs functions of healthcare companies worldwide from development to market and beyond, compliance work.

Clinical Trials - We have extensive experience of the preparation, submission and approval process for clinical trial applications in the INDIA, US, EU markets, and major international clinical trial conducting countries. Our team can provide guidance and support on all aspects of the application.

We can provide guidance on INDIA, US, EU, and international clinical trial regulatory requirements.

Pharmaceutical - The team is comprised of consultants with experience of all aspects of regulatory affairs of pharmaceutical products in markets worldwide

Medical Devices- VAATSALYA CLINICAL provides a full range of consulting and contract services for the development and registration of medical devices. Our consultants have vast experience of all aspects of this field and we specialize in providing the right consultant to work on your project. 

 

Regulatory Compliance

 

As a company, we have been involved with some of the wide-ranging regulatory compliance projects in the pharmaceutical industry. This is a simple concept to ensure that each commercially-supplied medicine meets the terms laid out in the marketing authorization for each country. Our expertise has ensured the supply of regulatory professionals to establish what’s registered where, how it should be made and how it is being supplied. We specialize in rapid assessment of the situation, providing a clear plan of action, agency and inspectorate liaison and robust implementation to deliver a fully compliant situation.

 

Clinical Trials Phases I – III (Regulatory Affairs)

CTA preparation and submission.

EC preparation and submission.

International CTA preparation and submission

Expert advice ( therapeutic areas, markets to undertake trial, filing strategies.

Scientific Advice or Protocol Advice (clinical or quality, advice application procedure, – US,India and EU agencies.

GCP Audits

Reports required for submission dossier

Respond to any questions and incorporate any amendments during CT process.

 

Pre-Submission Activity (Regulatory Affairs)

Scientific Advice or Protocol

Filing strategy INDIA

Filing strategy US ( NDA,  ANDA )

Pre-submission agency meetings

GMP Audits; Validation requirements; TPM sites identified

Dossier preparation

Intelligence gathering

 

Filing & Submission (Regulatory Affairs)

Pre-agency meetings

Dossier submission

 

Approval (Regulatory Affairs)

Obtain license (product license, wholesale dealer’s license, import license.)

 

VALIDATION (IQ/OQ PQ)

Our IQ, OQ, PQ qualification and validation programs help your company assess, develop and implement regulatory compliance at the level you need, including the FDA’s Rule 21 CFR Part 11.

As your partner, we can determine the level of compliance and validation appropriate for your company. We then customize our services to compliment your in-house compliance and qualification / validation programs, allowing you to optimize resources. 

Our three-phase program allows you to pick the compliance level suitable to your needs.

Phase I Regulatory Compliance Assessment: We examine and inspect laboratory guidelines; perform system and equipment reviews, and assist you through QA audits (pre-FDA inspections). We also provide compliance reviews and services for QC operations.  

Phase II Regulatory Compliance Development: We assist you in creating, modifying or enhancing the effectiveness of your Quality Programs.

Phase III Regulatory Compliance Implementation: We assist you in executing the specifics of your compliance programs.

Our qualification / validation offers:

Complete maintenance history, system history and inventory of components and documentation.

Universal IQ, OQ, PQ template format.

Performance verification of laboratory equipment for routine R&D, QA/QC, EPA, FDA, and client-compliance operation.

Pre-scheduled and annual instrument qualification / validation programs matched to your company’s needs and budget.

Cost effective and fast turnaround for your laboratory equipment IQ, OQ, PQ verification.