Services Nya

NEW PRODUCT DEVELOPMENT

1. New Product concept identification – Need Gap Area Identification –Competitor product evaluation & category mapping – Scientific literature search – Ingredient selection with rationale – Articulating technical USPs.
2. Prototype designing – RM finalization & procurement – Design trials.
3. Formulation Development – Development trials – Process optimization trials – Scale-up batches – Stability batches.
4. Analytical Development - Method designing -Method validation -Stability sample analysis
5. Documentation - RM Specification – Finished Product Specification & Method of analysis - ingredients reference - Claims as per literature – Protocols for validation – stability – Tech transfer.
6. Licencing – Document preparation – Liaisoning with Drug Authority
7. Product Licencing, Licence & draft label document preparation as per Rule 161 pf D&C Act, Liaison with Drugs Control Authority.

REGULATORY SERVICES

1. Regulatory way-outs to resolve drug development issues – Impurities – Analytical – Stability – container closure related issues.
2. Regulatory strategy and planning of huge work volumes triggered due to acquisitions / business integrations
3. Strategic planning for global clinical trial during drug development.
4. Strategic planning of Regulatory submissions with minimum available data by the time of submission or with anticipatory regulatory risks.
5. Reference medicinal product-related challenges when dealing with more than one market.
6. Regulatory strategies to submit a response to CRL from Health Authorities or response to HA queries.
7. Strategic planning to take the products approved in one region to other regulated markets.
8. Assess the potential risks in the scope of the project/phase and have risk management plans firmed up.
9. Break up the activities into major and minor activities and interlink them so that each individual milestone is met without any slippage.
10. Review of development documentation.
11. Ensure the readiness of the facility for undertaking exhibit batches by conducting facility audit and documentation review.
12. Monitor the tech transfer activities on behalf of the customer, including the process validation.
13. Support during regulatory inspections.
14. Support for redressing queries, warning letters and in audit compliances.
15. Develop strategies with forecasting, fundamental processes cross pharmaceuticals commercial business, their interaction, and the impact of external/internal influences on effectively develop and deliver forecasts as well as on decision making.

OTHER SUPPORT WORKS

1. Manufacturing Formula and Process documentation – Master Formula Record and Batch Manufacturing Records – Percentage formula – Batch formula – critical control points – Rejection Recovery – Reconciliations.
2. Stability study – Stability study protocol and Report – Study design and execution for accelerated conditions and Real Time Conditions – Stability indication Parameters and Specifications – Sample analysis with shelf-life determination.
3. Bills of Materials with costing and competitor details – Paper formula ready for commercial manufacturing.
4. FG specification and Test Procedures.
5. Licence and draft label designing as per Drugs & Cosmetics Act – Designated formats as per Rule 161, D&C Act ready to submit document.
6. Manufacturing Process design – Scale up report, Batch Manufacturing Record.
7. Technology transfer - Protocol and Report – Assistance for commercialization.
8. Trouble shooting of existing product – change control with impact analysis.
9. Process validation – Protocol and reports.
10. New Analytical Method Development & validation – Protocols & Reports.
11. Manufacturing line set-up – Capex - Machine selection – equipment validation.
12. Analytical / Microbiology laboratory set-up – Capex – Machine selection – equipment validation.
13. Consultation and facilitation for GMP certification – SOP and SMF
14. Safety and efficacy documentation as per Rule 158B – Claim docket – PMS by Doctors – by Literature support.