Patents

We have 25 years of experience with National and Multi-National companies. Many patents already awarded which are commercialized and available for multi-faceted services. Many patents are readily available which can be utilized as it is.We can help you with registration of your patents in limited time. We have solution for various disorders.

Publication

QualPharma is the monthly magazine providing a wide range of knowledge and upcoming news and events on pharma regulatory, pharmacovigilance, quality assurance, quality control of food and pharma Industries, We track the trends and issues that affect the industry here in India and across the world. We deliver independent, authoritative and trustworthy content through impartial, balanced and informed opinion and analysis.

The Learning and development Journal QualPharma-The first and most cherished pharma digital magazine having a wide number of readership all over the world, has been capturing the essence of Pharma Quality. QualPharma has its corporate office at New Delhi and Operating office at Ahmedabad. QualPharma has made its special place among pharma readers and is an informative and unbiased voice on industry trends, regulatory movements, technological and scientific advances. The publication highlights key movements in Quality Assurance, Control, Regulatory, Manufacturing, Formulation development, Pharma engineering, Patents, Sales/Marketing, drug delivery, bioprocessing, instrumentation, microbiology and Hot news bites. Quality and efficacy is bolder in thought for QualPharma team. It raises pharma issues, engages the community, gives a strong point of view on issues that matter and shapes opinions in pharma world. In the process it has become a "compulsory read" for those who value the quality drug product.. Naturally, it has built up a loyal, intelligent and conscious Pharma readership.

Projects & Workshops

QualPharma organizes workshops and offer projects to Pharma Students. The workshop includes case studies as well. Common topics are as follows:

  • Quality Assurance and Quality Control
  • Out of specification
  • Non Confirming Products
  • Deviations
  • ISO 22000
  • Hazard analysis critical control point

Regulatory Affairs

We have the best of the people who have worked in the industry at very senior level in Quality and Regulatory departments. Our team works with the clients to develop simple and workable solutions for the regulatory problems. We believe in making the high quality documents that makes our clients more aggressive in filing the dossiers in various markets. We work on cost saving and efficient timelines for submissions. We can help you by assisting you in the following areas:

  • Preparation and submission of DMFs and ANDAs ( CTD & eCTD formats)
  • Facilitation for the timely approval of DMFs and ANDAs
  • We evaluate and facilitate the resolution of complex exclusivity issues involving generic and branded products
  • Domestic & International Expertise
  • We undertake the regulatory work of Pharmaceuticals , Biologics , Medical Devices and Food Industry
  • We perform due diligence audits of applications in association with the sale of pharmaceuticals
  • Preparation of Dossiers for various markets
  • Review of the existing dossiers for improvements
  • Documentation complying to FSSC 22000, ISO 22000, ISO 9001 and GMPs.

Technical Education (Our Initiative for Students )

At QualPharma’ we do not work only for the industry but also feel that we owe to the society and hence deliver various seminars to the college students irrespective of pharmacy or science streams. The Founder & Director is associated with various colleges as Technical Faculty. All other team members also follow the foot steps of him.

We have also designed special training programs for Pharm.D., B.Pharm. and M.Pharm. students. This is our small initiative in bridging the gap between academics and industry. We may not offer a full proof solution to this problem faced by the industry in India but we are very sure that this will deliver very good results in near future.

We run various courses according to the needs of the students and colleges. This varies from 3 days small compact course to 90 days full theory + Practical course for all the streams. Providing the education at an affordable cost by which more and more students can be benefitted is our goal. This will release the pressure on industry getting good and reasonably trained manpower.

We have also designed technical courses for people working in the industry but would like to grow further by learning more and more in this competitive world. You can contact us for more details…

Consultancy

Staying at the leading edge of pharmaceutical training means that we keep abreast of every major industry issue. You can put that knowledge to good use by taking our advice on a broad range of regulatory and technical matters, including:

  • Preparation for Regulatory Inspections
  • Implementation of cost-effective and compliant Quality Management Systems
  • Troubleshooting on a wide range of technical problems
  • Advice on facility design, validation and operation
  • Preparation & review of Validation Master Plan & Site Master file as per current guidelines
  • Preparation of responses to regulatory inspection reports, warning letters and remedial work
  • Advice on Quality Control laboratory design and execution along with set up
  • Advice on design of Pilot Plants and its qualification
  • Advice on system evaluation
  • Guidance on Risk Management
  • Guidance on design and set up of R&D

GMP Training

We are very much committed to help our clients in ensuring a long-term success and effectiveness with compliance which is becoming more and more difficult in today’s regulatory world. To ensure this happens , we offer a full range of training programs for all the levels of an organization, from senior executives to chemists/officers and manufacturing operators. Our training programs can be customized to meet each organization's requirements. In addition to classroom training, we are also able to deliver on-the-job training and "train the trainer" services. We have a special expertise in Training the Internal Auditors for the organization which works as a watch dog for them. Our training programs are designed in English and various local languages like Hindi especially for the manufacturing operators.

Group training on your site (or a selected offsite location) is a great solution to kick start a new initiative or to offer customized GMP training that is aligned with company objectives while staying within financial constraints. It's the ideal solution if you have ten or more people to be trained at a time. Few are the examples of some of the training programs that we offer are as follows :

  • GMP Training for all the employees in Pharma and Food Industry
  • Evolution of GMP
  • Quality Risk Management as per ICH guidelines
  • Internal Auditor’s Training Program
  • Stability Guidelines as per ICH- Q1 guidelines
  • Good Documentation Practices
  • Deviation Management
  • Change Control Management
  • CAPA
  • Introduction to Qualification/Validation
  • Calibration Management and OOC concept
  • GMP for warehouses and Distribution centers
  • 5 S techniques
  • Regulatory Approaches to Product Development, Quality Evaluation and Clinical Assessment
  • Introduction to Generic Drug Development
  • Regulatory requirements of DMF & ANDA submissions
  • Understanding Schedule M
  • Pharmaceutical Quality Risk Management- ICH Q9 & ASTM

Creating Brand Image

We believe in creating a visual brand identity by providing our promotional inputs. We can develop market strategy for you to develop a successful business. We can also provide promotional support for International Marketing.