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Leading Service Provider of Analytical Services, Medical Writing Services, Clinical Research Services, Training Services, Regulatory Services and Cep Application Services from Mumbai.

Analytical Services
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Analytical Services

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We offer wide variety of pharmaceutical testing services with the help of various analytical testing laboratories monitored by dedicated professionals. Our services include chemical analysis, Instrumental Analysis and analytical method development with validations as per ICH requirements. We pride ourselves in providing fast, accurate and cost effective results to our customers. We maintain direct line of communication between our clients and analytical facilities to ensure that all testing is performed to the fullest of customer satisfaction.

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Medical Writing Services

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Protocol writing Designing of Case report form. Writing subject information sheet / informed consent form. Designing study logs - Screening log, enrollment log, subject identification log, drug accountability log etc. Designing patient dairy if required. Report writing.

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Selection of investigators and sites - Selecting potential investigators from our data base as per the need of the protocol. Monitoring of clinical trials - The monitors will visit regularly to the site to assure smooth conduct of the study. Audit of clinical trials - Independent audit of any clinical trial including sponsor, investigator site and path lab is undertaken. Investigator Site management is done by trained clinical research coordinators to ensure trial documentation as per the ICH - GCP guidelines and schedule Y. Pharmacovigilance - AE / SAE documentation, reporting and follow-up as per the regulatory norms to ensure safety of the trial subjects. Data management - All the clinical trial data is collected and compiled for statistical analysis.

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Training Services

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On-going training in the theory and practice of GMP & Good Quality Control Practices is essential to up grade the skills & knowledge of an Quality Personnel. We can design custom training courses to meet your needs. This can be done through presentations, individual & group work, discussions, practical training & demonstration at the clients site. Such training can be on general testing procedures, ICH guidelines or experts in the respective fields who have hands on experience up their sleeve. In addition, we can also provide annual training programmes as per pre designed calendar to maintain continuity to the training process.

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Regulatory Services

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Our regulatory team has experience of working within the big pharma and generic industry as well as with various regulatory authorities. Our team will work with you to meet your needs for pre authorization, post authorization or organizational support as well as good regulatory and Pharma covigilance experience.

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Cep Application Services

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Advice on Dossier completion Preparation and management of CEP application (certificate of suitability) in both hard copy & e-CTD format e-CTD Dossier preparation including expert overview Preparation of applicants and restricted parts of Drug Master Files including expert overviews. Preparation of summary of product characteristic, labeling & patient information leaflets. Variation management. Regulatory support during the assessment of abridged National, DCP & MRP application. Post authorization regulatory & pharmacovigilance support. We can assist you once you have your marketing authorization for ensuring your post authorization requirements and responsibilities are met. Our services include preparation of annual product reviews. Preparation of Dossier for submission to Indian Regulatory Authorities.

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Auditing Services

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Our auditing services provide powerful and effective recommendation for numerous major pharmaceutical manufacturers as well as for smaller companies and facilities.
With our "mock" FDA pre-approval audits we can help to ensure that problem areas are identified and addressed before the real inspection.

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Regulatory Affairs

Regulatory Affairs

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cGMP Compliance Service

cGMP Compliance Service

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BE & Clinical Monitoring

BE & Clinical Monitoring

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Training

Training

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