Services

• Complex generics development
• Oral solid dosage forms (IR, SR, MR, DR, Palletisation, HME)
• Liquid orals, Semi-solids, Onco products, Injectables
• Reverse engineering, Q1/Q2/Q3 estimation
• Formulation development using QbD & DOE
• Competitive Generic Therapy (CGT)

• API characterization & forced degradation studies
• Method development & validation (ICH Q2)
• Impurity profiling, elemental impurities (ICH Q3D)
• Pharmaceutical equivalence & compatibility testing

• Process scale-up and validation
• cGMP pilot batch execution
• Training staff for efficient tech transfer
• Support for regulatory query responses

• Alternate API sourcing
• Yield improvement and cost reduction
• Product shelf-life extension
• Excipient replacement strategies

• CTD/eCTD/ACTD dossier preparation
• Health authority query response
• Lifecycle management & labeling updates
• Import licenses and regulatory certificates (India)

• Site audit support (UK/EU QP)
• Inspection readiness & gap analysis
• EU/PICs GMP inspection support

• BA/BE study design and CRO coordination
• Protocol review, report analysis, Module 2.4/2.7/4/5
• Medical writing & risk assessments

• Setup and manage PV activities
• RMP & PSMF preparation
• SDEA and safety variation handling
• Referral procedure support (Article 30 & 31)

We conduct custom trainings depending on customer needs for employees at all levels who are engaged in the manufacture, storage, or distribution of Pharmaceutical, Nutraceutical, Biotech, Medical Devices, Ayurvedic & Homoeopathic, Food, and Dietary Supplementary Products.

Our aim is to provide equal opportunities without any discrimination on the grounds of caste, creed, race, color, disability, marital status, religion, or gender. Reyanvi Healthcare strives to maintain a work environment that is inclusive, respectful, and growth-oriented for all employees.