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Packaging Material
We make available premium quality Packaging Material for all kinds of packaging. The offered lot is prepared using the best is class raw material and modern work methods. In addition to this, we make sure that the material is procured after complete quality satisfaction. Well documented, secure, and practical, our payment procedures are client friendly. We offer our clients with different online and traditional options to make payments and ensure they are convenient.
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Pharmaceutical Dossier
Sarims provides consulting and dossier solution for product registration. We write and review dossier as per European CTD / ASEAN CTD / non-CTD (country specific guideline).Administrative Documentation (writing and review): Registration Application & Covering Letter Letter of Authorisation Legal & Administrative (GMP,CoPP, FSC etc) Documents Summary of product (SmPC) and Pack Information Leaflet (PIL) or Pack insert Label and carton contents Technical Documentation (writing and review): Summaries – Quality & Non-clinical Drug master file (S Part of Dossier) Non-clinical Overview (Module 2) PDR, Process validation, AMV & Stability Studies Specification, Method of analysis & Certificate of Analysis of Raw materials & Packing Materials Specification, Method of analysis & Certificate of Analysis of Formulation product Module 4 (Non-clinical) Module 5 (Non-clinical) Common Technical Document (CTD) -The Common Technical Document (CTD) is a set of specifications for a dossier for the registration of medicines. The CTD was developed as per the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)We prepare all modules of Common Technical Document: Module 1. Administrative information and prescribing information Module 2. Common Technical Document summaries (Overview and summary of modules 3 to 5) Module 3. Quality Module 4. Nonclinical Study Reports (toxicology studies) Module 5. Clinical Study Reports
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new product development
Every new product development project begins with the customer’s desire to create a product that will succeed in the market. With our experts the customer finds a partner who will assist in meeting that goal. Our expertise lies in the processing of Active Pharmaceutical Ingredients into secondary pharmaceuticals using technologies such as blending, granulation, drying, pelletizing, crystallization, tableting, coating, drug loading etc.,Granulation for controlled release, extrusion, spheronization, ï¬uidization techniques, spray drying, melt extrusion, oral dispersion technology and roller compaction are all technologies that are increasingly being used in modern pharmaceutical production and oï¬ers many advantages in terms of product quality, costs and time savings.Our Process Development team ofers expertise and advice on new product trials, feasibility trials, scale-up studies, process support at customer sites and training programmes; these services greatly beneï¬ts both R&D and manufacturing of the Industries : Effervescent tablets Sugar coating Modified release technology Enteric coating Timed release technology MUPS Wurster coating
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Process Optimization & Process Standardization
We assist and standardize your existing solid dosage form's process in granulation, Compression, Tablet coating, Wurster coating to increase the productivity and decrease cost, material and time.We convert the coating process from non-aqueous to aqueous in order to reduce the cost. Validating film coating, enteric and sugar coating process, pellet coating/ drug loading etc. To serve in solving formulation related issues like DT, Dissolution, Coating related issues.Area's of Expertise : Granulation Compression Film Coating Enteric Coating Sugar Coating Wurster Coating Drug Loading Functional Coating
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