Wave Pharma Limited is involved in Importation and Batch Release, and Storage of medicinal product followed by distribution.

We have a team of highly skilled and experienced Quality Assurance Specialists and Qualified Persons.
• We also provide services to Pharmaceutical company to apply MIA, WDA and post approval changes on their behalf.
• Ensure compliance to QMS as per ICH Q10, Directive 2001/83/EC, Directive 2003/94/EC, 2013/C 343/01, EudraLex Volume 4 & MHRA Rules and Guidance for Pharmaceutical Manufacturers and Distributors.
• Help in establishing QA structure like writing SOPs, maintenance change control, deviations, CAPA, Quality metrics etc.

• End to End Regulatory Services covering development of Regulatory Strategy.
• Support for Scientific advice for complex or innovative dosage form.
• Managing various dosage forms – Oral Solid (IR & MR), Oral Liquids, Injectable including OTC product.
• Expertise in Generic or hybrid MAA, Branded Generics application, FDC submission, and bibliographic application.
• Advice for the selection of Reference product to b used in development and Bio-equivalance study.
• We work in conjunction with contract manufacturing site to support during tech-transfer activities inline with Registered information and to meet current Regulatory expectation.

• Consulting and preparation of all five CTD modules (M1, M2, M3, M4 & M5) for registration purpose as pe EU or FDA requirement.
• Review of Dossier and Preparation of GAP Analysis Report
• Work with development companies to upgrade old dossier to bring them inline with current requirement
• Specializes in commercialising very old marketing authorisation to the market.
• Regulatory submission in eCTD format.

• Regulatory submission through CP, MRP, DCP or National routes across EU member states/UK.
• Handling of Administrative, Quality and Safety variation through Grouping & Work-sharing procedure.
• Management of National phase after closure of MRP/DCP and CPs.
• MHRA portal and CESP submission.

• Support for the preparation, review and submission of Pre-IND meeting package
• Regulatory submission for both ANDA or NDA 505(b)2 application or post approval changes.
• Electronic Submission Gateway (ESG) services for securely transmitting submissions to the Agency using authorized submission portal
• Submission in eCTD format
• FDA Local agent services

We at Wave Pharma Limited understand the regulatory compliance and its impact on the quality and safety of the medicinal product and meets the expectation by:
• Development of system for Regulatory compliance like SOP and Guidance documents.
• Ensure to keep updating Registered information as per current ICH and regulatory requirement.
• Expertise in evaluation of change control proposed from the API supplier for DMF/CEP updation, Manufacturing site change, Analytical or R&D proposed changes including Complex Site transfer or Formulation changes.

Our services in this area include:
• Author/review of Non-clinical and clinical expert report (Module 2.5, 2., 2.6 & 2.7) for initial and post approval marketing authorization dossier.
• Informative texts (SmPC, PIL, labelling) of the marketing authorisation dossier.
• Design of leaflet text and mockup as per QRD template to meet user testing requirement
• Author/review of risk management plans
• Response phases/queries during marketing authorisation procedure.
• Rationales for safe use of drugs/excipients (other impurities).
• Review of bioequivalence study protocols and study reports
• Recommendation for the requirement of Bioequivalence study or well-established procedure.
• Recommendation for the selection of write reference product and respective strength
• Advice on the qualification of impurities and any further toxicological study requirement
• Our UK based Clinical and Non-clinical expert ensure that documents has been prepared that meets Regulatory expectation.

All publishing services are supported by our experienced regulatory team, whose deep knowledge ensure end-to-end submission management process, through:
• Document level publishing by hyperlinking, bookmarking and formatting.
• Document and Submission levels check as per eCTD requirement.
• eCTD publishing.
• eCTD lifecycle management for continued support to all future sequences.

• Our auditing team offers Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP) audit services helping our clients to ensure that all relevant regulatory requirements (ICH Q7, EudraLex Volume 4) are met. We provide auditing solutions for all types of pharmaceutical products such as active pharmaceutical ingredients (APIs), intermediate and drug products.
• GLP Audit:We have rich experience in conducting GLP Audits which are essential to ascertain suitability & capability of testing laboratories for its Qualify Control Infrastructure, Practices and the enforcement of Data Integrity guidelines.
• GCP Audits:We have network of associated organization and person who offer this service exclusively under our banner. With the tough regulatory guidelines for all CROs across the globe, it is crucial for all dossier developers to conduct an audit prior to initiation of a BE / Clinical Study
• Feasibility audit:A feasibility audit of a facility is conducted prior to entering into a toll manufacturing and for tech transfer of a new product at a CMO site. This is a very important aspect often overlooked, which can adversely impact project timelines, costs and resultant revenues.
• GAP Analysis Audits:GAP Analysis Audits are conducted by us specifically to support the clients in Facility Compliance. The guidance provided by us also includes extensive training to the staff in maintaining Compliance and ready preparedness for Regulatory inspections.