Worked with More than 200 Pharmaceutical companies
Our Profile
PPC is a professionally managed company with roots back to 1987. It was founded by a visionary Mr. Rajkumar Gupta who is masters from Haffkine Institute in Mumbai. Currently, his son Mr. Sumit Gupta Masters in Business Administration from Australia has joined the business
Presently the company is located in Pune. The working team consist of numerous well qualified and experienced regulatory professionals having proven capability for authoring chemistry, manufacturing, control, clinical and nonclinical aspects regulatory submissions and market authorizations. The company serves clientele all over the globe.
Our Mission Statements, Standards, and Objectives
Our mission is to provide intelligent regulatory solutions to our esteemed clients.
Our Products and Services
Our services includes the followings
To author, edit, refine and release regulatory submissions such as CTD, CEP, DMF, ANDA, and NDA to the customers or to FDA as necessary.
To resolve queries on regulatory filings most intelligently
To guide the local/foreign pharmaceutical business for export registration /marketing authorizations all over the globe
To guide and implement certification under COPP scheme run by world Health organization
To audit and certify the pharmaceutical, raw material, excipients, container closure companies for GMP compliance.
To guide on FDA 483 Notifications
Our Accomplishments
We have provided services to some of India’s well known companies in Pharmaceutical and allied industry.
We have successfully audited , documented and submitted US DMF , CEP,CTD,ACTD Certification/Registration campaign for may Pharmaceutical companies and Pharmaceutical Exporters/Importers .We have successfully helped several companies for COPP and CGMP Certifications by Local, WHO and International Regulatory Agencies
We've assisted clients in resolving FDA queries, site amendment, method development, process development, SOP optimization, registration renewal, online dossier submission, inspection & certification management and we create great technical documents and reports.
Recently we added electronic customization and submission of Common Technical Documents for marketing Authorization in US, Europe and Australia.
“Let us help you with your next regulatory submission.”
Our Professional Affiliations
Our company is affiliated with many Industry Associations including Indian Drug Manufacturerers Association, Indian Pharmaceutical Association, Pharmexcil Enumerate your affiliations. We regularly contribute review articles in Pharma express and Linked in Professional groups like TOPRA, RAPS etc.
Our Social Contributions:
We are socially motivated. We have contributed to the social programs for tree plantation, medical treatment, medical checkup, health counseling etc.
Testimonials and References
We have received large number of testimonial from our clients of international repute. However, respecting the confidentiality we are unable to disclose their name.
Success Stories
We have enormous success stories. We are unable to disclose the name of the clients but following are the projects where our services have helped them to resolve their problems.
Contact Information
Our contact information is below.
Email – gupta2dmf@gmail.com Alternatively please click to send us the enquiry.
