The clinical journey of a new product is often difficult and lengthy. It involves preclinical development, clinical trials, regulatory submissions and finally regulatory approval to market the product. The most tedious and stringent of all these is regulatory affairs. Regulatory bodies have become stricter than ever before and are constantly evolving guidelines and regulations for the betterment of mankind. At Global Pharma Tek, we understand the nuances of complex regulatory requirements and offer regulatory support to Pharma and Biotech companies at every stage of their clinical development. Our Regulatory Affairs (RA) department in cooperation with our international network of regulatory affairs professionals, facilitate regulatory solutions for drug or device at every stage. We provide regulatory advice, solutions and support for every regulatory requirement.
Our Global Regulatory Services Include:
DMC is an important technical document of the registration dossier and contains CMC (chemistry, manufacturing & control) information about the active pharmaceutical ingredient.
One of the most important parts of any registration application for Marketing Authorization is Common Technical Document (Product Dossier). It needs to be compiled in CTD Format/ ACTD Format or local country format for its submission to Food & Drug Authority (FDA) or Ministry of health (MOH) or any other equivalent authority. In addition to CTD, other technical documents and legal manufacturing permissions are also required for market authorization. At Global Pharma Tek, we understand the complexity of this task and can help you prepare the entire registration file for drug product registration around the globe.
Dossier writing and compilation as per CTD Format Common technical Document (for regulated and semi regulated market like Middle Eastern countries, CIS Countries, European Union, Canada, Australia, USA, Japan, etcÐ
Dossier writing and compilation as per ACTD Format Asian Common Technical Document (for Asian Countries like Thailand, Vietnam, Malaysia, Singapore etc.)
Our interdisciplinary, expert and supportive regulatory team members are flexible to take care of your complete regulatory responsibility or offer you a program especially tailored to your needs. We can help you compile and write any specific module or the entire technical document as per your need. In addition to this, we also offer support services to companies in establishing their Document Management and technical writing system. We help them in drafting templates on BMR, COA, MOA, and other technical documents.
Our regulatory affairs team aims to ensure the preparation, submission, and approval of regulatory compliant documents for every clinical trial stage. We work in close collaboration with the client s team to ensure quality, global compliance, consistency and support at every stage.
Our full-service or customized regulatory solutions cater to the needs of every company- Good for both Start-up and scale up companies.