Analytical Development Services

VivaTest offers instant resource deployment for stand-alone analytical services. We have a team of chemists and senior scientists, product experts, quality testing personneland a robust project management and communication system to ensure highest Quality Analytical Services.

Analysis offered with utmost precision in the field of :

• Pharmaceuticals
• Cosmetics
• Chemicals
• Agricultural products
• Herbs and Ayurvedic products
• Food products
• Petrochemicals and oils
• Pesticides
• Animal Health
• Metallurgy

Formulation Development Services

VivaTest offers Formulation Development Services across diverse Dosage forms such as Oral Solids, Oral Liquids, Disperse Systems, Semi- Solid preparations, Ophthalmic Drug Products and Nasal Systems.

VivaTest has a state of the art facility meeting International Standards and Regulations. The Analytical Laboratory is GLP compliant and the Formulation Development Laboratory is GMP compliant with perfect in-built systems.

Quality Assurance

At VivaTest we strictly follow Standard Operating Procedures for establishing Quality Assurance Practices, such as Preparation, Maintenance, Definition, Classification, Change Control of Quality and Master File documentation; Recording and Reporting Procedure for Deviations Management; Quality Concern Investigation Process; Customer Complaint Handling Procedures; Quality Audit Procedures; Vendor Assessment, Evaluation and Certification Procedures; Procedures on Training and many others.

Regulatory Affairs

VivaTest’sin-house team of regulatory experts facilitates meeting challenging timelines and our processes are designed to provide cost effective study management solutions towards regulatory authorizations.

Key Services

• Pre-Formulation studies
• Development of the core formulations with different Dosage forms like Tablets / Capsules / Ointment / Cream / Gel / Syrup / Suspension / MDI / DPI / Nebulizers / etc.
• Analytical Method Development and Validation
• API and Impurity Characterization
• Stability Studies
• Manufacturing Process Validation
• Validation Batches/ Batches for Clinical Trials
• Technology Transfer
• QbD and DOE application as per client requirements
• Documentation for all our Formulations for CTD/ ACTD/ eCTD/ CEP
• Dossier Preparation/ Submission
• Drug Master File for API, Excipients and Primary Packaging material in India and Overseas

Stability Studies

We support stability studies for early R & D, Complete ICH studies, Phase III / NDA supporting studies, commercial / Post approval studies, Stability studies for drug registration, follow up Stability studies, Container / Compatibility studies

Stability testing services include,

Long-term Stability

Accelerated Stability

Stress Testing (forced degradation)

Drug (API) – Excipient Compatibility