We hold the hands of the clients to design, implement & strengthen cGMP & quality management systems in the organizations.

With a team of highly qualified & experienced professionals, we help our clients to find out the GAPS within their organizations based on four criteria viz-infrastructure, systems, documentations and manpower capacity & capabilities. This supports them to upgrade their standards so as to meet current regulatory norms.

Our auditing services provide powerful and effective recommendation for numerous major pharmaceutical manufacturers as well as for smaller companies and facilities. With our "mock" FDA pre-approval audits we can help to ensure that problem areas are identified and addressed before the real inspection. We conduct audits to evaluate and advice on adequacy of current Good Manufacturing Practices (cGMP) & Good Quality Control Practices, compliance programmes for intermediates, active pharmaceutical ingredients (APIs) & finished drug products. Necessary corrective and preventive actions shall also be mentioned in our audit reports. Because of our experience, we are able to provide simple & pragmatic advice for all the major International Regulatory and GMP standards including EU, USA, Canada, Australia, WHO and more.

Our expertise are in the following types of audits:

Our regulatory team has experience of working within the big pharma and generic industry as well as with various regulatory authorities. Our team will work with you to meet your needs for pre authorization, post authorization or organizational support as well as good regulatory and Pharmacovigilance experience.

We can provide the following services to our customers:

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.

Quality By Design In Analytical Research Considering Critical Attributes

Through our experience and by working closely with the client we are able to streamline the development process to reduce cost. Methods are developed and validated according to either a specific client protocol or our own Standard Operating Procedure.

We undertake method development and validation for:

Additionally we also routinely deliver scientific assistance to clients helping them in

Our associated laboratories are well equipped with vast array of analytical instruments and capabilities. Few sophisticated instruments to list here are:

Having state-of-the-art, Compliant analytical facility is a dream of every pharmaceutical testing unit. We are pleased to provide you with one.

The scope of our services in lab setting up includes :

Clinical Research Services offered for Phase II-IV clinical trials in all therapeutic areas conducted in India.

Project Management.

Data management - All the clinical trial data is collected and compiled for statistical analysis.

Medical writing

On-going training in the theory and practice of cGMP & Good Quality Control Practices is essential to up grade the skills & knowledge of a 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.

The scope of our training programmes covers the following:

VAB pharma has associates in US as Regulatory agent and in Europe as EU GMP consultant. In US, We have associations, with two leading companies one of them is the leading Analytical Testing and Formulation Development Company and other is renowned Regulatory Firm who act as a Regulatory Agent. In Europe, we have associations with EU GMP Consultants for triggering the inspections and working as a Regulatory Agent.