Regulatory Services for Complete Clinical Continuum
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 co-operation 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:
- Drug Substance Services: DMF, IND, Manufacturing, Import & Exports
- Drug Product Services: NDA, ANDA
- Pre-IND and Pre-NDA meeting with FDA
- Writing and compilation of INDs, NDAs, ANDAs, 505(b) (2) and supplements
- eCTD submission
- Providing the clearances
- Orphan Drug Submissions
- Regulatory support for clinical trials, Facility Inspections
- CMC (Chemistry, Manufacturing, Control) and Pre-Clinical toxicology
- Regulatory agency interaction
- Case Report Forms (CRFs)
- Product information (SPC, PILs)
- RLD Sample Procurement
- Pricing and Market Authorization Approval
- Product Life Cycle Management
Drug Master File – DMF
DMC is an important technical document of the registration dossier and contains CMC (chemistry, manufacturing & control) information about the active pharmaceutical ingredient.
Global Pharma Tek Offers following Drug Master File services:
- DMF compilation in CTD Format / Country Specific format
- Open & close part DMF writing
- Review of DMF For Submission
- Type II (Active Ingredient) DMF Preparation and submission to US FDA
- European Certificate of Suitability (CEP) submission and Preparation
- Canada Submission & Preparation
- Analytical Testing – Elemental Analysis, Validations, Stability, etc.
CTD – Dossiers
One of the most important part 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. We, at Global Pharma Tek understand the complexity of this task and can help you in preparing the entire registration file for drug product registration around the globe.
Global Pharma Tek offers following Dossier Compilation services:
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, etc.)
- Module 1 – Administrative Information
- Module 2 – CTD Overview
- Module 3 – Drug & Product Part /CMC
- Module 4 – Non-Clinical
- Module 5 – Clinical
Dossier writing and compilation as per ACTD Format – Asian Common Technical Document (for Asian Countries like Thailand, Vietnam, Malaysia, Singapore etc.)
- Part I – Administrative Documents
- Part II – Quality Documents
- Part III – Non-Clinical Documents
- Part IV – Clinical Documents
Highly Skilled & Flexible Regulatory Affairs Team
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 in compiling and writing 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.
The aim of our regulatory affairs team is to ensure preparation, submission and approval of regulatory compliant documents for every stage clinical trial. We work in 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.