RIVANOVA

WHO-GMP · ISO 9001:2015 certified manufacturing · Serving 25+ countries

Research & Development

Curiosity, run under
controlled conditions

A 12,000 sq. ft. research centre where 42 scientists translate molecules into stable, manufacturable, patient-ready dosage forms.

Research capability

Development that stays
inside the building

Most mid-size formulators license their dossiers. We do not — and it is the single most expensive decision we have made. It is also what allows us to answer a regulator's question about excipient compatibility in an afternoon rather than a fiscal quarter.

Our 12,000 sq. ft. research centre houses formulation development, analytical method development, packaging science and a pilot plant under one roof. A stability signal observed on Monday reaches the formulator who can act on it by Tuesday.

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Scientists across formulation, analytical and packaging development.

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Sq. ft. dedicated research and pilot-plant floor area.

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Formulations developed and commercialised in the last three years.

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Stability chambers covering ICH Zones II and IVb plus photostability.

Illustration of molecular research and formulation development

Formulation Development Centre

Pilot plant · analytical development · packaging science

Focus areas

Where our science is concentrated

Solubility & bioavailability

Solid dispersions, particle-size engineering, self-emulsifying systems and surfactant screening for BCS Class II and IV molecules.

Modified release

Matrix and reservoir systems, pellet-in-capsule multi-unit particulates, and enteric protection for acid-labile actives.

Stability science

Forced degradation, excipient compatibility and photostability studies that select the pack from evidence rather than convention.

Analytical development

Stability-indicating methods developed and validated to ICH Q2(R2) — specificity, linearity, accuracy, precision and robustness.

Paediatric palatability

Taste-masking through coating, complexation and flavour systems — because an unfinished course is a failed treatment.

Scale-up & tech transfer

Documented transfer from 1× laboratory batch through pilot to full commercial scale, with process validation on three consecutive batches.

Development pathway

Bench to commercial batch

Typically 14 to 22 months from concept to first commercial batch, depending on the complexity of the dosage form and the regulatory pathway in the destination market.

Pre-formulation

Physicochemical characterisation of the active: solubility profile across pH, polymorphic form, hygroscopicity, particle size distribution and flow properties.

Excipient compatibility

Binary and multi-component mixtures held under accelerated conditions to identify interactions before they appear in a stability study six months later.

Prototype formulation

Multiple trial formulations screened against dissolution, content uniformity and physical attributes, narrowing to two or three candidates.

Analytical method development

A stability-indicating method is developed and validated in parallel — you cannot trust a stability result produced by an unvalidated method.

Pilot batch & stability

Pilot-scale manufacture followed by accelerated (6 months) and real-time stability under the destination market's climatic zone.

Technology transfer

Formal handover to production with a transfer protocol, critical process parameters defined and operator training completed before the first exhibit batch.

Process validation

Three consecutive commercial-scale batches manufactured and tested against predetermined acceptance criteria before routine production begins.

Lifecycle management

Ongoing stability commitment, annual product quality review and continued process verification for as long as the product remains commercial.

Bring us a development brief

Custom formulation development, reformulation for a new climatic zone or a taste-masking challenge — our R&D team scopes projects under NDA.