Drug Development & Medical Device
Regulatory Consulting
IND / NDA
CTD / Modules
CTA / MAA
Industrial Standards
FDA Design Controls
FDA 510k / PMA
Drug Development Regulatory Consulting Overview
We understand meeting Drug Development Regulatory compliance is a daunting and tedious process. The pharmaceutical industry in the US is regulated by FDA 21 CFR 312/314 IND/NDA. From R&D basic research, discovery, pre-clinical studies, IND submission clinical trials, NDA to commercial launch, post market surveillance, auditing, and remediation. Alectena provides industry’s finest Drug Development Regulatory Consulting service and ensure our client meets the most up to date compliance.
For European regulation is governed by EMA for CTA/MAA. The process is similar to FDA drug regulatory and we adopt the most up-to-date regulatory process.
Alectena offers extensive service to the diverse scenes of drug development business. We cover not only US and EU but also global market.
Common Drug Development Regulatory Consulting Services
- IND – Investigational New Drug
- NDA – New Drug Application
- CTA – Clinical Trial Application
- MAA -Marketing Authorization Application
- CTD – Common Technical documents
Our Approach
- Pre-Research Assessment: Analyze the characteristics of drug to determine the FDA drug development path. This prevents further workload later in the development phase.
- CTD / Modules: The creation of regulatory document that covers module 1 to 5. This is essential for IND and NDA submission
- IND submission: Once discovery and sufficient non-clinical data is gathered
- NDA Submission & Approval: After successful completion of clinical trials, the regulatory document is sent to the FDA for review
- Project Audit: After the initial commercial launch and closure of project, we provide internal audit for the documentation.
- Pharmacovigilance : The clinical trial phase 4 for safety, observation of effectiveness, and side effects of drug.
Medical Device Regulatory Consulting Overview
We understand meeting Medical Device Regulatory compliance is a daunting and tedious process. The medical device industry in the US is regulated by FDA 21 CFR 820.30 Design Control. From R&D to commercial launch, post market surveillance, auditing, and remediation. Alectena provides industry’s finest Medical Device Regulatory Consulting service and ensure our client meets the most up to date compliance.
Particularly, the European regulation is shifting from MDD to MDR. This change may require many organizations to review their existing products and documents to be able to compliant with new regulation.
Alectena offers extensive service to the diverse scenes of medical device business. We cover not only US and EU but also global market.
Common Medical Device Regulatory Consulting Services
- Regulatory Strategy & Assessment
- Pre-Market Notification 510(K)
- Pre-Market Approval (PMA)
- FDA Audit Preparation
- IEC, ISO Standards
- Foreign Regulatory Compliance
- MDD / MDR
Alectena offers an optimal regulatory consulting service for your business. Whether it’s new product development, remediation on the existing product or documentation. Our experts are experienced in dealing with the FDA and regulatory bodies around the world. We minimize your business’s regulatory workload and provide effective documentation.
Our Approach
- Pre-Research Assessment: Analyze the characteristics of device to determine the FDA Medical Device Classification. This prevents further workload later in the development phase.
- Pre-Market Notification: Process to determine types of 510(k) or PMA.
- Project Audit: After the initial commercial launch and closure of DHF, we provide internal audit for the documentation.
- Post Market Surveillance: The adherence to the most up-to-date compliance and remediation activity in order to meet the latest revision of standard.
Let Our Experience Be Your Guide
Drug Development & Medical Device Regulatory Consulting
Document Control
The Pharmaceutical and Medical Device companies often overburden the amount of documentation. A common mistake is that creating more documents is better than less. This is not necessarily true. Creating more documents does not only take more time but also it creates potentials of having a conflict with other documents. Alectena offers a review of your current regulatory documentation process and identify areas of improvement to establish reliable document control systems.
In addition, Alectena’s Business Intelligence services substantially improve the Document Control systems and assists the regulatory process.
Medical Device Regulatory Consulting
Meet The Best Medical Device Regulatory Consultant Today
At Glance
A Case Study
17%
Reduction in unnecessary documentation
10%
Reduction in change request processing time
FDA Pre-Market notification clearance and improved turn around