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RESEARCH CENTER Innovates PHARMA Solution
Medicotrials is a leading Indian Contract research organisation providing a wide range of outsourcing clinical trials, BA/BE Studies and regulatory consultancy to the international pharmaceutical industries. Promoter directors of Medicotrials are Mohammad Shahbaz Alam and Mohammad Ayaz Alam. Ayaz has completed his education from United Kingdom in Pharmacology and he has diverse experience working with global CRO. He is expertise in clinical studies and pharmacovigilance. Shahbaz is having core competency in international regulatory affairs and medical writing. He has got his pharmacy and business management education in India. Medicotrials was founded in 2007 as Outsourcing Clinical Development and Regulatory Support Services. By 2010, the company had significantly expanded both its clinical development services and its Regulatory Support Services. Taking a strategic decision to divide the business and allow both units to pursue their core activities with their own distinct identities. We are now well established enterprise for full range of outsourcing CRO coupled with independent regulatory consultancy company. Meher Pharma International (www.meherpharma.com) takes care of regulatory consultancy and Medicotrials is an established CRO. We have list of more than 100 satisfied clients from the global sphere. Medicotrials is the first CRO in the world who runs independent regulatory consultancy company. We use proven procedures for swift project completion and reduced project cost. We are proud of our work and committed to quality for each project we undertake. Please take some time to examine our web site to learn about our capabilities and services, and contact us, if we can be of assistance to your company. USP GLIMPS o Fastest Clearance/NOC From DCGI o Lowest Rate For Bulk Order o Six Sigma Quality Approach o Independent Regulatory Unit OUR SERVICES Clinical trial (Phase 1-1V) BA-BE/ PK-PD studies Regulatory affairs Medical Writing
CLINICAL TRIAL Feasibility Studies: Medicotrials Research Centre helps in identification and selection of qualified investigators in accordance to the therapeutic area of the clinical trial from the investigators database. A robust feasibility is carried out at various sites and the data is analyzed to provide you the best of the sites.
Investigator Selection: With variety of therapeutic segments and different rare diseases prevalent in human beings, India offers advantage to research related endeavours .Due to our strong reach and cordial relations through rich network of investigators, real estimation is made with the protocol specific questionnaire. Depending upon the protocol specific site requirements investigators are shortlisted. Preference is given to the investigators with the following credentials: Past experience of similar type of studies Site readiness Patient pool for the study Geographical reach for visits and sample collection Willingness for the participation in study Accessibility
Project Management: Once the protocol is approved by the investigator and dossiers for the study are submitted to the Regulatory and Ethics committee project is handed over to Project Manager. Site Management: We offer A well trained site coordinator decicated to the trial,assisting CRF completion/EDC,Tracking source documents,Patient follow-up & tracking,supporting informrd consent process,Drug inventory and accountability,sponsor communication, AE reporting & follow up and Query resolution Monitoring and auditing: Experienced team of physicians and medical monitors for safety management of the investigator sites. BA-BE/ PK-PD STUDY We outsource Bioavailability study in GCP/GLP compliant centre. We offer various studies on bioavailability, bioequivalence and pharmacokinetics on variety dosage forms as per the CDSCO and international regulatory guideline. All the critical steps of BA/BE studies undergo vigorous quality control checks to ensure data integrity and authenticity. Also all the studies are monitored by an independent quality assurance department. We have constituted a dedicated team to develop and validate new methods for BA/BE studies. Our expertise in Bio Studies includes BA/BE Studies, Phase I Studies (conducted in healthy volunteers) and PK/PD Studies.
B.E WAVE OFF: Our regulatory team can guide you about bioequivalence wave off as per the Biopharmaceutics Classification System (BCS). We are competent enough to arrange dossier of B.E wave for domestic and international market under the preview of USFDA. Apart from the above mentioned services we can also assist you in getting approval of new drug, bulk drug, vaccine, medical device from CDSCO. We can undoubtedly help you for import registration of new drug, bulk drug, vaccine, medical device etc from CDSCO. REGULATORY SERVICE: We have extensive working knowledge of a wide range of drug molecules. All activities are carried out in strict compliance with regulatory and ICH GCP requirements. We have successfully cleared regulatory audits from CDSCO (India), USFDA, AFSSAPS (France) and ANVISA (Brazil),EMEA,UKMHRA etc. Now a days getting NOC or license is not an easy task from CDSCO as applications have increased multifold over the time and simultaneously documentation guideline has become very stringent. Earlier approval time was fixed for all the services on the CDSCO website and now approval time is not fixed for any services. Every month changes are going on in Drug & Cosmetic Act (Regulatory Guideline) and due to lack of awareness you get query letter rather than getting approval. No doubt, you can lose your business if you won’t get approval as per your planning and commitment with the clients. Sometime you start giving huge consultancy services for urgent approval because you have to retain your customer but you remain shaky whether you will get it or not. We are here to solve your problem related to CDSCO. We are having core competency in documentation and be aware with the changes in guideline. Chance of approval remains approximately 100% with us because our team pre-screened all the applications and guide to the clients for appropriate changes. Most importantly we are very strong in follow up. Therefore, you can save time, money and commitment working with us. We honour your trust for augmentation of profitability of your organisation. We are giving you Time line of approval for the following services: Approval of Clinical trial NOC: 30 working days Approval of B.E NOC: 30 working days Approval of Import Test license: 20 working days Approval of Import Test License on urgent basis: 1-5 working days
MEDICAL WRITING We caters full range of scientific and regulatory medical writing documents that includes drafting, designing, and reviewing of the following documents on Phase I-IV trials: Clinical Trial protocols (ICH E6) Clinical study reports (ICH E3) Investigational New Drug Application(INDA) New drug applications (NDA) Abbreviated New drug applications (ANDA) Clinical sections of common technical document (CTD and eCTD) Periodic safety update reports(PSUR) Investigator Brochures Patient Informed Consent forms Case Report Form and Diary Card design (paper format) Patient Questionnaires and Survey Reply forms Drafting, review and submission of Scientific Letters and Research Papers Drafting of Regulatory Progress Reports Product Monograph, News Letter Rational Justification of New Drug for CDSCO Submission. Clinical Trial Wave of for CDSCO Submission.
You can reach us Dr.Shahbaz Skype-meherpharma Mob+0091-9818131498
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