Formulation Development Service

Listing ID #3754934

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Business Type Service Provider
Preferred Buyer Location All over the world

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Service Details

During stages of early product development, medwisdom can offer useful advice on issues of importance for future expedient approval.
In our specialised field of pharmaceuticals, biologics, biotech, cosmetics, herbal, medical device. We inform clients of requirements for manufacturing and control, emphasising the importance of the documenting process as well as product consistency. We have expertise in the design of assays, and can develop statistical models for their evaluation according to pharmacopoeial requirements.
Review of production processes and facilities and design of validation protocols are also within our capabilities.
In addition, we can produce qualified input for the planning of appropriate stability studies, non-clinical studies and clinical trials.

Company Details

MEDWISDOM is a pharmaceutical consultant. We offer a wide range of services in the areas of pharmaceutical development, Regulatory affairs, Patent, Clinical, Non clinical, Manufacturing, Facility audit.
REGULATORY AFFAIRS:
 Dossiers (eCTD /CTD /NeeS /EAC /ASEAN/Country specific format)
 Conversion of Non-CTD to CTD or CTD to eCTD or NTA to eCTD
 Product lifecycle Management (Renewal and variation)
 Drug master file (DMF) and CEP
 MEDICAL DEVICES
 EXPERT REPORT (Quality/nonclinical/clinical)
 Company registration
INTELLECTUAL PROPERTY
 Evaluation of Product / process patents
 Development strategies as per non infringing technologies
 Patent drafting and submission
PACKAGING DEVELOPMENT
 Development of packaging components
 Proposing the packaging material specifications
 Development of packaging change parts
ANALYTICAL DEVELOPMENT
 Development of new analytical methods for Assay, RS, Dissolution etc.
 Validation of analytical methods
 Transfer of analytical methods from lab to QC
FORMULATION DEVELOPMENT
 Development of New pharmaceutical products – tablets / capsules / powders /
injections / eye drops / Injections / Creams / Ointments
 Resolving any bio‐equivalence challenges
 Reformulation of existing products
 Simplification of complex manufacturing processes of existing products
 Stability improvement in existing products
 Cost reduction of existing products
 Technology Transfer from lab scale to exhibit batch / commercial scale
 Suggestion of new equipment
 Designing of R&D Laboratories etc.
TECHNOLOGY TRANSFER
 Ready technology (Formulation as well as API) for execution
TRAINING
 GMP/ISO Training
 Technical training
 Regulatory training
AUDIT:
 Quality Management system audit
 GxP Audit
PHARMACOVIGILANCE:
 Pharmacovigilance System Establishment
 Development of Risk Management Plan (RMP), Periodic Safety Update Reports (PSUR)/PBRER/PADER
 Safety Data Exchange Agreements
 Safety Database
 Technical team trainings
 ICSRs: Processing & Reporting
 QPPV Services
 Audit & Inspection support
 Signal detection & management
 Global & local literature surveillance
 xEVMPD/IDMP Support
 other Pharmacovigilance Consulting Support
OTHER SERVICE:
 Clinical and non-clinical support
 Export and import
 Local Agent (India)