Are You Looking For Expert Documentation Support?
Reach out to Medwisdom Lifescience for overall documentation support, whether it is for medical device, pharmaceutical, clinical trial, or audit inspection. Our experts will guide you through all the documents required for submission and approvals.
- Comprehensive Documentation Support
- Pharmaceutical, Clinical Trial Documents, Medical device and More
- Precise Documents Preparation
Regulatory Documentation Support
Our Documentation Services
Pharmaceutical Documentation Support
Our pharmaceutical documentation service includes preparation, management, submission, and review of compliant documents. Starting from research and development documents management to product development, clinical documents, dossier preparation, and post marketing surveillance (Pharmacovigilance) documents, we ensure end to end accuracy in documentation for pharmaceutical industry. We are committed for providing high quality standard documentation support, ensuring documents meets guidelines and achieve fast approvals.
GMP Documentation Services
Good manufacturing practice (GMP) documentation is a essential for upholding product integrity and regulatory compliance with global regulations. Our services for GMP documentation includes:
- Drafting of Batch Manufacturing Protocol (BMP), Batch Manufacturing Report (BMR), and Batch Packaging Report (BPR)
- Preparation of equipment maintenance report
- Preparation of Corrective and Preventive Action (CAPA)
- GMP audit related documents preparation
Pharmaceutical Documentation Management
Pharmaceutical documentation management is an important aspect of regulatory standard. Medwisdom Lifescience pharmaceutical documentation management service are designed to simplify your processes through:
- Setting up Electronic Documents Management System (EDMS)
- Digitalization of pharmaceutical documents
- Using centralized archive of pharmaceutical documents for efficient retrieval
Standard Operating Procedure Documentation
Preparation of well defined and structured SOPs are the backbone in achieving operational excellence in pharmaceutical industry. At Medwisdom Lifescience, we offers well structured SOPs development services aligned with the regulatory requirements, covering many departments like manufacturing, quality control, quality assurance, equipment operation, and many more. Our SOPs are crafted to be effective, user friendly, and aligned with the regulatory standards, to ensure regulatory compliance with industrial guidelines.
Regulatory Documentation Support
Regulatory documentation is crucial and highly required component for securing registration of products and market acceptance. At Medwisdom Lifescience, our experts team having profound experience, ensures that all the regulatory documentation must be aligned with the regulatory authority requirements. We assure you for delivering accurate and precise regulatory documentation support. Our services for regulatory documentation includes:
- Preparation of Common Technical Document (CTD) and Electronic Common Technical Documents (eCTD)
- Regulatory compliance for pharmaceutical product registration
- Post approval change documents
- Drafting of Pharmacovigilance Safety Update Report (PSUR) and Risk Management Plan (RMP)
Why Is Regulatory Compliance Documents Required?
Smooth Inspection
Accurate documentation reduces stress during audit and inspection by ensuring your product or service meets regulatory standards.
Mitigation of Risk
We ensure precise and up to date documents, mitigating the risk of failure or delays in product approval process.
Effective Operations
Complete regulatory compliance guidelines provides a roadmap for companies to improve efficiency in work.
Why Choose Us?
Global Regulatory Solutions
We provide pharmaceutical documentation service globally with country specific regulatory guidelines. Our team ensure regulatory compliance of documents meeting country specific regulatory framework like USA, EMA, ASEAN, CIS, and many more.
Flight to Foundation Support
From preparation of documents for research and development, clinical trial management, to product approval and post marketing surveillance documents, we assist our clients in each and every step of product lifecycle, saving your time and efforts.
Cost Effective Service
Connect with us to avoid costly errors and regulatory pitfalls in product development and approval process through our guidance and support. Our professionals with deep industrial knowledge of compliance documentation may result in avoiding errors and mistakes.
What Our Clients Think About Us
Frequently Asked Questions
What Are The Essential Documents Required For Drug Approval?
Essential documents required for drug approval includes:
- Common technical document (CTD and eCTD dossier)
- Drug Master File (DMF)
- Investigation New Drug (IND)
- New Drug Application (NDA) or Abbreviated New Drug Application (ANDA)
- Certificate of Analysis (COA)
- Legal Documents (Certificate of pharmaceutical product (CoPP), Product Permission (PP), Free Sale Certificate (FSC)
What Is The Difference Between CTD and eCTD?
CTD dossier is an structured format for regulatory submissions having five modules:
- Module 1: Administrative information
- Module 2: Summary of Module 3,4, & 5
- Module 3: Quality information of drug substance and drug product
- Module 4: Non clinical data
- Module 5: Clinical data
eCTD dossier is an electronic version of CTD, standardized for online submission for product registration.
What Are Regulatory Documentation In Pharmaceuticals?
Regulatory documentation is compilation of all the scientific, technical, and legal documents required for pharmaceutical product registration. It must meet the regulatory requirements for acceptance and fast product approvals.