We are one of the leading and reliable REGULATORY SERVICE PROVIDER of INDIA offering services to you.
We are an integrated Institute as well as cater to the pharma companies with specialized services.
You can relax while we work and deliver the perfect job for you. We possess a great team with relevant experience, capable of multi- tasking & full of confidence for taking up the huge task to complete Regulatory Project responsibility and making you avail high speed services. Our team sticks to the core values of Integrity, Discipline, Teamwork, Commitment and Ethics with an aim to work out an alliance between you and us that could enable you to break new grounds in sales and marketing. Our Regulatory Services and Pharmacovigilance Training are finely tailor-made to meet our client’s requirements and add value to their organization by ensuring cost effective way of Time and Money spent.
We hereby extend our invitation with the following aspects of Pharma Regulatory Affairs:
DMF (Preparation, Filling and Registration of Drug Master Files for API. Type II, III and IV for API, Primary Packaging Materials and Excipients respectively).
Scale up and Tech. Transfer Projects for Finished Formulations; various Dosage Forms.
Dossiers services (Documentation of CTD’s, ACTD’s, eCTD’s etc… of Finished Formulations eg., Tablets, Capsules, Injections, MDI’s, DPI’s, Nebulizers, Gels, Ointments and many more).
Guidance for GMP, GCP, GLP and updating of same.
Post submission query reply, Query solving & Experts opinion on same.
Phase II, III, IV Clinical trials & Toxicity studies
Preparation of SPC’s, Package information leaflets (PIL), Periodic Safety Update Reports (PSUR’s).
COS/CEP Preparation / Submissions & Audits.
The Experienced panels of experts can advise you on strategic, cost effective and innovative product development planning’s, system setups for cGMP according to WHO / USFDA / MHRA / MCC / ICH guidelines as well as GMP Compliance, starting right from Plant Design to GMP Approval by any Regulatory Agency worldwide.