JVAG PHARMA CONSULTANTS
Our Services
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.
