We Offer;
Regulatory Services :
- Regulatory Strategy : For various markets like the US, UK, EU, Canada, Australia, SA, Newzeland and ROW, etc.
- Regulatory Submissions for Drugs: Which includes dossier preparation, Module 1 to 5 (Pre-IND, IND, ANDA, MAA, ANDS etc) and DMF preparation, review and submission to various Regulatory Authorities in eCTD, customized support on particular Modules can be provided.
- Regulatory Submissions for Medical Devices: 510k submissions, CE Tech file preparation and submission as per latest MDR requirements.
- Gap Analysis : Due diligence of the dossiers, DMF, and API supplier evaluation.
- Publication : Can provide services for eCTD publication.
- Undertake management of query response to Health Authorities.
- Life Cycle Management support for renewal, Annual report, Variation submissions, CEP monitoring, GMP status monitoring.
- Labeling management : PIL, SmPC, preparation, SmPC and PIL updates, bridging study and User testing in EU and RLD identification.
- Drugs import license for testing and analysis purpose (form11) /India
- Import license and registration certificate for import of drugs (form 10 & RC in form41) /India
- New drugs Approval for import and market. (form 45)
- New drugs Approval for manufacturing & market for drugs, biological products and medical devices (form 46)
- Import license and RC for medical devices in India
- Biological-MA, CT NOC, NDA in form 45 ,46 and 28D for sale and distribution of vaccine ,blood products and sera, Test license in form 11 for CT
- New drugs-CT NOC,BE NOC for domestic purpose, new drug approval in form 45,46 test licenses
GMP Services :
- Help in arranging the API Manufacturing site audit by the UK/EU QP
- Help in arranging the FP manufacturing site audit by UK/EU QP
- Site Gap Analysis and preparedness for various GMP inspections like EU/UK/SA/NZ/AUS/PICs etc.
- Triggering of the EU/PICs GMP inspection.
Clinical Research :
- BA/BE study design strategy, protocol preparation, and Review.
- Identification of CRO
- Commercial negotiation with CRO and contractual arrangement with CRO
- CRO Audit
- Identification of Suitable Reference Product for BE study.
- Monitoring of BA/BE study
- Review of BA/BE report and preparation of Module 2.4/2.7/4 and 5
- Literature Screening
- Medical writing like Non-Clinical Overview, Clinical Overview.
- Bio-waiver strategy.
Pharmacovigilance :
- Setting-up and managing the Pharmacovigilance activities
- Can help in Handling of various EMEA Referral procedures like article 30 and 31.
- PSUA procedures
- RMP writing
- PSMF Preparation
- SDEA
- Safety Variations
Strategic Alliance and Business Development :
- Helps in finding out partners for development, manufacturing, BA/BE CROs, Clinical Trails and Pharmacovigilance service providers.
- Assist in acquisition & divestment of MAs/ANDAs,
GVP and GCP Auditing :
- Undertake GCP and GVP auditing by the qualified auditors.

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