JVAG PHARMA CONSULTANTS
Navigating Pharma Regulations with Expertise & Precision
ABOUT US
JVAG Phrama Consultants
J.V.A.G. Pharma Consultancy, founded in 2011, is a leading provider of regulatory and technical consultancy services for the pharmaceutical industry. Our team of experienced professionals specializes in helping pharmaceutical companies navigate the complex regulatory landscape, ensuring that their products meet the necessary standards for approval in global markets.
With a dedicated approach to high-quality services, J.V.A.G. Pharma Consultancy offers personalized and innovative solutions for product registration, compliance, and regulatory strategy development. Our global footprint allows us to serve clients across various continents, supporting their efforts in achieving regulatory approval and market success.
Our organization’s values of integrity, discipline, collaboration, commitment, and ethics drive us to provide the best service possible while building long-term, trust-based partnerships with our clients.
OUR
MILESTONES
2011
Founded to provide regulatory consultancy services for pharmaceutical manufacturers.
2014
Expanded our services internationally, helping clients from various countries achieve regulatory success.
2017
Built a strong team of 24 skilled regulatory professionals.
2020
Successfully helped more than 500 products obtain global regulatory approval.
Recognitions
- Recognized as one of the top global regulatory consultancy firms.
- Acknowledged for providing consistent, high-quality, and reliable services to our clients.
- Established a reputation for customer satisfaction and industry leadership in regulatory affairs.
Quality
- Commitment to Excellence: Quality is at the core of everything we do. We ensure our regulatory services are delivered with precision and reliability, meeting all international standards and client expectations.
- Quality Control System: Our robust quality management system ensures that we consistently provide services that are compliant with global regulatory standards, focusing on minimizing risk and maintaining consistency in every project.
JVAG PHARMA CONSULTANTS
Our Services
J.V.A.G. Pharma Consultancy offers a comprehensive range of services across various pharmaceutical categories to ensure regulatory compliance for your products:
Drug Master Files (DMF)
We specialize in the preparation, filing, and registration of Drug Master Files (DMFs) for Active Pharmaceutical Ingredients (APIs), excipients, primary packaging materials, and more. Our services ensure that your components meet the regulatory standards required for approval in various countries. We handle US DMFs, Chinese DMFs, Japanese DMFs, and Type II, III, IV, and V DMFs. This includes preparing and filing DMFs for APIs (Type II), primary packaging materials (Type III), and excipients (Type IV). Our goal is to simplify the regulatory process, helping you achieve compliance and approvals efficiently and effectively.
CEP / Certificate of Suitability (COS)
We specialize in the preparation, filing, and registration of CEPs / COS, We are expert in handling post submission queries by EDQM. We have filled more than 100 CEPs /COS till date
Primary Packaging Materials
Our team provides regulatory guidance for the registration and approval of primary packaging materials, ensuring that your packaging solutions meet safety standards and are in compliance with global regulations.
Finished Dosage Forms Dossiers and Technology Transfer
Our services cover a wide range of finished dosage forms, including tablets, capsules, injections, MDIs (Metered Dose Inhalers), DPIs (Dry Powder Inhalers), nebulizers, gels, and ointments. We help prepare CTD, ACTD, eCTD dossiers for regulatory submission to ensure successful product approval in international markets.
GMP Services
Our Panel of Experts is having reach experience in setting up systems like GMP as per WHO / USFDA / MHRA / EMA/ ICH / EDQM guidelines as well GCP / GLP compliance as per ICH Guidelines. We also undertake total turnkey basis project for GMP Compliance, starting from Plant Design to GMP Approval by any regulatory agency worldwide.
Scale up and Technology Transfer (TT)
various Dosage Forms. Dossiers services (Documentation of CTD’s, ACTD’s, eCTD’s etc… of Finished Formulations e.g. Tablets, Capsules, Injections, MDI’s, DPI’s, Nebulisers, Gels, Ointments and many more).
BA/BE Studies
J.V.A.G. provides Best Approved and EU/US agency audited CRO’s for performing all the mentioned studies, Phase II, III, IV Clinical trials & Toxicity studies.
Medical Devices
We offer regulatory consulting for medical devices, guiding our clients through the submission process for CE Marking, FDA approvals, and other international certifications. From product development to post-market surveillance, we support medical device companies throughout the regulatory process.
Cosmetics
For the cosmetics industry, we assist in preparing and submitting regulatory documents to meet FDA, EU, and other country-specific regulations for skincare, hair care, personal care, and other cosmetic products.
Dietary Supplements
Our consultancy extends to dietary supplements, where we help with product registration, claims substantiation, and compliance with regulations from global authorities such as the FDA, EFSA, and others.
Herbal Drugs
We specialize in regulatory consulting for herbal drugs, guiding our clients through the approval process with a focus on safety, efficacy, and compliance with global standards.
Veterinary Products
Our services cover veterinary drug products, including those for pets, livestock, and poultry. We ensure these products meet the specific regulatory requirements set by authorities such as the FDA, EMA, and local regulatory bodies.
Excipients
We offer services for the regulatory registration of excipients used in pharmaceutical formulations, ensuring compliance with the latest standards and guidelines for excipient approval.
Core Values
Why Choose Us?
Practical and Effective Regulatory Solutions
We offer actionable solutions to complex regulatory challenges related to CTD, DMF, ANDA, GMP Audit and Validation, helping you navigate the regulatory landscape with ease.
Commitment to High-Quality Service
Our dedicated team provides top-tier, reliable services that ensure compliance and support the successful approval of your products in global markets.
Continuous Support and Training
We offer proactive system support and provide on-site training for key personnel to ensure that your team is equipped with the knowledge and skills to manage regulatory tasks effectively.
On-Time Delivery
We understand the importance of deadlines. We ensure timely submissions to regulatory bodies, keeping your projects on track without delays.
Expert Network Access
With our well-established network of industry experts and consultants, we offer your organization access to specialized knowledge across areas like APIs, Excipients, Formulations, Clinical, and more.
Customer-Centric Approach
Customer satisfaction is our top priority. Our reputation is built on reliability, responsiveness, and timeliness, ensuring long-term partnerships and successful outcomes for your business.
testimonials
What Our Clients Say About Us?
J.V.A.G. Pharma Consultants has been an invaluable partner in our regulatory journey. Their deep expertise and strategic guidance helped us successfully register our products in multiple international markets. Their team is professional, knowledgeable, and always ready to assist with tailored solutions.
Dr. Rajesh Mehta
Navigating complex pharmaceutical regulations can be overwhelming, but J.V.A.G. Pharma Consultants made the process seamless for us. Their team provided step-by-step support, ensuring compliance and timely approvals. Their commitment to quality and precision is truly commendable.
Anita Sharma
We have worked with J.V.A.G. Pharma Consultants for years, and their expertise in regulatory compliance has been instrumental in our growth. Their global reach and in-depth knowledge have enabled us to expand our business across various markets with confidence.
Vikram Patel
The team at J.V.A.G. Pharma Consultants is highly professional and detail-oriented. They provided us with comprehensive regulatory strategies that streamlined our product approval process. Their support has been crucial in helping us meet international pharmaceutical standards.
Dr. Sneha Iyer
testimonials
Frequently Asked Questions
We specialize in regulatory and technical consultancy services for the pharmaceutical industry, including product registration, compliance management, regulatory strategy development, and technical support to help companies meet global approval standards.
Our expert team provides end-to-end regulatory support, ensuring that pharmaceutical products comply with international guidelines. We assist with dossier preparation, submission, compliance checks, and liaising with regulatory authorities to streamline approval processes.
Yes, we have a global footprint and provide consultancy services for multiple international markets, ensuring that pharmaceutical companies meet the regulatory requirements of different countries, including the US, Europe, Asia, and more.
Our team consists of highly skilled professionals with years of experience in the pharmaceutical regulatory sector. Since our founding in 2011, we have successfully guided numerous clients through the complex regulatory landscape.
Absolutely! We provide customized solutions tailored to the needs of startups, SMEs, and established pharmaceutical companies, helping them achieve regulatory compliance and expand into global markets.
While our primary focus is on pharmaceuticals, we also provide consultancy for biotech, medical devices, nutraceuticals, and healthcare-related industries that require regulatory guidance.
Simply contact us via email or phone, and our team will schedule a consultation to understand your requirements and provide tailored regulatory solutions.
Yes, we offer ongoing regulatory support to ensure compliance even after product approval, including pharmacovigilance, renewals, and periodic updates as per global regulatory changes.
Our dedicated approach, deep industry expertise, and personalized solutions set us apart. We provide end-to-end regulatory assistance with a focus on efficiency, accuracy, and market success.
JVAG PHRAMA CONSULTANTS
Why Choose Us?
- We work in harmony with our clients and regulatory agencies like the FDA to ensure smooth processes.
- Our focus is always on meeting regulatory requirements effectively and efficiently.
- We add value to your existing systems, enhancing their performance and compliance.
- We provide honest and reliable support whenever you need it.
- We assist clients in addressing and resolving all regulatory queries.
- We act as active partners, working closely with you every step of the way.
- We keep a close eye on regulations and regulators, staying updated to keep you ahead.
- We help design tailored regulatory strategies that fit your organization’s needs.
- We dive into the details, interpret events, and guide you toward the best course of action.
- We build relationships based on mutual trust and satisfaction, ensuring a partnership that works for you.
Our approach is simple: we’re here to make regulatory challenges easier, so you can focus on what you do best. Let’s work together to achieve your goals.
