Services
SERVICES
Technical Services
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- Innovative Generic Drug Development
- Process Simplification
- Productivity Improvement
- Technology Transfer
- Exhibit batches and Process validation
Quality Assurance
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- Investigation and Root Cause Analysis
- Pre-Post Regulatory Audit and support in resolution for 483 and WL
- QMS Audit and Remediation
- Vendor Audit for Third Party and API
- Quality Culture Transformation
- Training
- System Simplification
Quality control
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- Gap Assessment Audit
- Facility remediation
- Computer system Validation (CSV)
- Data Integrity Assurance
- Investigation GAP identification
Bridging of consultation for Regulatory Affairs
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- Dossier Gap Analysis & Remediation
- DMF / ASMF / CEP Dossier Preparation
- CMC writing & Regulatory documentation review
- Regulatory dossier preparation and compilation for New product registration (CTD, ACTD)
- Support for Regulatory Submission and query resolution
Bridging of Pharmaceutical Development
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- Formulation Development of complex dosage forms
- Peptides and Hormones
- Extended Release Tablet/ Suspension
- General Injectable
- Ophthalmic
- Inhalation solutions
- Preservative free Multidose
Analytical Development Services
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- Analytical Method development support
- Analytical Method Validation
- Equipment Qualification (IQ/OQ/PQ)
- Training
- SOP preparation support
Contract Development Organisation (CDO)
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- CDO Bridging and Quality oversite
Contract Manufacturing Organisation (CMO)
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- Support on Identification of CMOs, necessary due diligence as per regulatory requirements, Bridge document and tech transfer between CMO and Client
Contract Testing Organisation (CTO)
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- CTL Bridging and Quality oversite
IT - Software Development
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Instant compliance with regulatory requirements,
including USFDA (Food and Drug Administration), 21 CFR Part 11, MHRA, EU Annex 11, GMP, GAMP - Customized GxP Software solution with its robust regulatory compliance
- ERP, LIMS, MES, and many more
Engineering Services & Equipments
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- Water Filter Plant
- Water Treatment Equipment
- Storage Tanks
- Reactor Vessels
- Shell & Tube-type Condenser
- Multi-effect Evaporators
Other Industries
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- Cosmetic and Nutraceutical Product Development through bridging
- New product development
- CMO service for both
- Marketing for both
Backpacking Trips
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Family Hiking Trips
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Water Sports
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Winter Sports
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Why Outdoor Adventure
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- Experience: Locavit liberioris possedit
- Reputation: Diremit mundi mare undae
- Guide Experience: Spectent tonitrua mutastis
What You Get
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- Private Hike: Locavit liberioris possedit
- Transportation: Diremit mundi mare undae
- Great Facilities: Spectent tonitrua mutastis