Medwisdom Lifesciences Private Limited
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| MEDWISDOM LIFESCIENCES PRIVATE LIMITED | |
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| Type | Private |
| Industry | Pharmaceuticals |
| Founded | 2017 |
| Slogan | Quality services/customer satisfaction |
| Headquarters | New Delhi |
| Number of employees | 21 |
History
Medwisdom Lifesciences is a private limited company. Medwisdom was established in 2017, and is the one of the provider of Pharmaceutical/Medical Device/Cosmetics/Neutraceuticals resource for the Regulatory Purposes including regulatory/Patent/Pharmacovigilance/Technology transfer etc. Medwisdom dedicated team is comprised of consultants with great experience of over Fifteen years in all aspects and at all levels of regulatory affairs in the worldwide markets. The services are designed to meet all of the latest regulations, helping clients to meet all of the stringent requirements of the Regulatory Agencies.
ABOUT US
MEDWISDOM is a Life sciences consultant.
We offer a wide range of services in the areas of DEVELOPMENT, TECHNOLOGY TRANSFER, REGULATORY AFFAIRS, PATENT, CLINICAL and NON-CLINICAL, MANUFACTURING, FACILITY AUDIT. We consist of team of expertise person having more than 15 years of experiences in the consulting. We are dedicated mainly to the QUALITY, TECHNICAL, REGULATORY AND TRAINING CONSULTANCY to PHARMACEUTICAL/DEVICE/FOOD INDUSTRY. We aim at helping small to medium size pharmaceutical companies in complying with the regulatory norms by providing and assisting them in their technical Matters.
We are providing services like compilation of regulatory files, DMF, Internal Audits, Pre-audits, Preparation for Regulatory or any other Audits, Professional training programs for skill development and Personality development for pharmaceutical staff and technical Professionals. On site cGMP and Technical Training is also our expertise and we believes in concept clearance for smooth and Quality Functioning of Pharmaceutical Industry.
MEDWISDOM is achieved a level of Excellence in REGULATORY SUBMISSIONS and compilation/review of Dossier, DMF for Pharmaceutical Products registration and well aware about CTD, eCTD, ACTD and other national submission requirements. We are capable of handling and answering all TECHNICAL QUERIES of registration authorities.
We are also providing the Quality assessment and monitoring services to international pharmaceuticals companies who are buying medicines from Indian manufacturers.
We have expert auditors team with us who are having more than 20 years individual experiences for auditing pharmaceutical companies.
SERVICES
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 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 - EVMPD/IDMP Support = other Pharmacovigilance Consulting Support
OTHER SERVICE:
- Clinical and non-clinical support - Export and import - Local Agent (India) [3]
JOIN OUR TEAM
If you have an exceptional track record including at least 10 years of industry or consulting experience and would like to be considered for life science consulting assignments, please send us an email so we can learn more about your capabilities.
We are also actively seeking individuals with outstanding expertise in fields within our core strategic interests to join our growing team of Partners.
Associates work exclusively through Medwisdom and enjoy a number of benefits, including the support of Medwisdom’s Partners, access to our global network of consultants and the opportunity to leverage our administrative functions. [4]
PRIVACY POLICY
We ensure privacy and confidentiality of the client’s data. A non-disclosure agreement (NDA)/ confidentiality agreement (CA)/Confidential disclosure agreement (CDA)/proprietary information agreement (PIA)/Secrecy agreement (SA) will be signed by us before starting or signing of any projects. As per company policy/norms, Privacy and confidentiality of data is our main objective.
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