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Regulatory Affairs

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Founded in 2008 by Dr. Vivek Jadhav, VAB pharma provides technical and regulatory expertise to manufacturers of Drug Products and Active Pharmaceutical Ingredients. We provide cost effective project proposals. Time is money when hiring consultants. Thereby we can reduce costs based on our intimate knowledge of subject matter. Our specialists are professionals having progressive and diversified experience of over 15 years in the recognized pharmaceutical organizations. We are highly motivated, dedicated and result oriented on management style. + Read More

Nature of Business

Service Provider

Year of Establishment

2008

Annual Turnover

Upto Rs. 50 Lakh

Regulatory Affairs

Regulatory Affairs

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Analytical Services
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Analytical Services

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We offer wide variety of pharmaceutical testing services with the help of various analytical testing laboratories monitored by dedicated professionals. Our services include chemical analysis, Instrumental Analysis and analytical method development with validations as per ICH requirements. We pride ourselves in providing fast, accurate and cost effective results to our customers. We maintain direct line of communication between our clients and analytical facilities to ensure that all testing is performed to the fullest of customer satisfaction.

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cGMP Compliance Service

cGMP Compliance Service

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BE & Clinical Monitoring

BE & Clinical Monitoring

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Training

Training

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Medical Writing Services

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Protocol writing Designing of Case report form. Writing subject information sheet / informed consent form. Designing study logs - Screening log, enrollment log, subject identification log, drug accountability log etc. Designing patient dairy if required. Report writing.

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Selection of investigators and sites - Selecting potential investigators from our data base as per the need of the protocol. Monitoring of clinical trials - The monitors will visit regularly to the site to assure smooth conduct of the study. Audit of clinical trials - Independent audit of any clinical trial including sponsor, investigator site and path lab is undertaken. Investigator Site management is done by trained clinical research coordinators to ensure trial documentation as per the ICH - GCP guidelines and schedule Y. Pharmacovigilance - AE / SAE documentation, reporting and follow-up as per the regulatory norms to ensure safety of the trial subjects. Data management - All the clinical trial data is collected and compiled for statistical analysis.

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Training Services

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On-going training in the theory and practice of GMP & Good Quality Control Practices is essential to up grade the skills & knowledge of an Quality Personnel. We can design custom training courses to meet your needs. This can be done through presentations, individual & group work, discussions, practical training & demonstration at the clients site. Such training can be on general testing procedures, ICH guidelines or experts in the respective fields who have hands on experience up their sleeve. In addition, we can also provide annual training programmes as per pre designed calendar to maintain continuity to the training process.

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