Matish research laboratories is focusing on developing multiple dosage forms and novel drug delivery systems which are capable of greater efficacy and better patient compliance
- Matish research laboratories is provide services to Micro, Small and Medium Enterprises, as well as large Pharmaceutical Organizations who are involved in the manufacture of pharmaceutical products.
- Conventional solid dosage forms such as immediate release tablets/capsules, effervescent tablets, soft gelatin capsules and orally disintegrating tablets/flash tablets
- Modified release dosage forms such as delayed release tablets/capsules, MUPS, tablet in tablet, pulsatile drug delivery system, osmotic drug delivery system, extended/controlled release dosage forms and time release dosage forms, Gatroretentive drug delivery system.
- Development of products based on Palletisation, HME technology.
- Conventional parental preparation including sterile solutions and suspension, oncology and non-oncology products.
- Novel injectable products such nano-suspension and nano-emulsion injectable, liposomal drug delivery system and long acting (microspheres) injection.
- Oral liquids ( Syrups, Suspensions, Emulsions, Lotions, Solutions ).
- Semisolids ( Ointments, Creams & Gels).
- Ophthalmic
We have the necessary wherewithal to provide all the services that are required to maintain a pharmaceutical industry in a perpetually compliant state by providing all the services that are required such as
- Pharmaceutical Development
- Packing Development
- Regulatory Affairs
- Project Management
- DMF/ANDA Support for Documentation/Experiments/Characterization
- Risk Assessment for BA/BE Failures
- Patent evaluation.
- Training
Pharmaceutical Development
Our team is capable of conducting breakthrough research and overcoming formulation difficulties with Cost effective product development. We do the Development of the product in the existing labs up to advance stage
- Formulation Development
- Pharmaceutical packaging development
- Reverse engineering (Q1 Q2 formulation)
- Reformulation
- Technology Transfer
- Preclinical and Clinical Development
Formulation Development
- Oral Solid Dosage Forms (IR ,SR, MR, DR, Palletisation, HME etc.)
- Semisolids ( Ointments, Creams & Gels)
- Liquid Orals ( Syrups, Suspensions, Emulsions, Lotions, Solutions )
- Dry Powder Suspensions
- Injectable
- Ophthalmic
- Reverse engineering for all kind of formulations
- Q1,Q2,Q3 estimation for all kind of dosage forms
- Regulatory clearance on strategy
- Method Development (all Segments based on Critical Needs)
- Method Validations as per ICH Q2 Guidelines
- Product development report (As per QBD approach)
- Isolation/Separation/Characterization of Chemical Substances/Impurities/Ingredients
- ICH Q3D – Elemental Impurities (Risk Assessment)
Reverse engineering (Q1 Q2 formulation)
- Q1, Q2 and Q3 Studies (Generic and RLD Comparison)
- Isolation/Separation/Characterization of Chemical Substances/Impurities/Ingredients
- Studies on Complex Formation Assessment in Formulation
- Physical, Chemical Characteristics of Excipients – Assessment and Compatibility Studies
- Polymorph Quantification (as Impurity or Binary Mixture)
- Characterization of Unknown Impurities and Elucidation of Structures
- API Sameness Studies
- ICH M7 – Genotoxicity Prediction and Assessment (API Projects and Others)
Reformulation
- Failure of Dissolution profile comparison against innovator
- Failure of assay during stability studies
- Failure of impurity limit during stability studies
- Stability studies
- Self Life Extension
Technology Transfer
- Technology transfer and troubleshooting during scale up process to the client site
- Exhibit batch manufacture
- Commercial batches process validation
- Qualification and Validation of Processes and Equipments
- Guide and train the staff to conduct an effective Technology Transfer , Qualification & Validation process in order to minimise/ eliminate the loss of time and money
- Responding regulatory queries related to development
Preclinical and Clinical Development
- Formulation evaluation
- In vivo screening for various indications
- Bio-equivalence Study design
- Risk Assessment for BA/BE Failures
- Toxicological Assessments
- In vitro and In vivo assays of PK parameters,
- In vivo screening for various indications
Regulatory Affairs
It is important to understand and define the clear regulatory strategy by considering the target markets/ regions, different patent terms and its extension, various application possibilities, data requirements, deadlines for launching products to be marketed in different markets/ regions.
We provide Technical Support in the below mentioned Areas:
- Preparation of Drug Substance and Drug product registration dossier
- Dossier Preparation & Submissions Support in CTD [(Electronic Common Technical Document (drug registration)] / eCTD, ACTD [Asian Common Technical Dossier]
- NeeS [Non-eCTD electronic Submissions (NeeS)] formats to different Health Authorities of Regulated and Semi-Regulated markets like US-FDA, Health Canada, Europe, UK-MHRA, MCC-SA, ANVISA, ASEAN countries and ROW markets including Indian DCGI and CDSCO
- Site Master file as per PIC/s & Local FDA requirement.
Training
We conduct Custom Trainings depending on customer needs to employees at all levels who are engaged in the manufacture / storage / distribution of Pharmaceutical / Biotech / Medical devices / Ayurvedic & Homoeopathic / Food / Dietary Supplementary Products.
