FAQ's

How PPC is valued for Rapid Regulatory compliance?

Many of the Pharmaceutical Companies may not have enough staff, expertise or time to meet all the regulatory requirements on fast track PPC services help them to

• Meet the timelines for registration of their products.
• Economize on separate staff for regulatory compliance
• Simplify and systemize regulatory submissions
• Decreases the risk of rejection of submissions
• address post submission queries

What are PPC commitments for regulatory compliance services?

• PPC provide personal attention to your submissions
• PPC maintain the highest standards of regulatory compliance, integrity and honesty.
• PPC Work tirelessly to complete your assignment in time and monitor registrations
• PPC provide practical, intelligent and strategic solutions to regulatory queries.
• PPC Maintain flexibility in adapting to changing needs of MOH
• PPC also provide emergency services to meet your critical requirements
• PPC Maintain clarity in all billable services and payment advises

Why customers stay with PPC over a long time?

• PPC provide quality service at a reasonable cost
• PPC meet their time frames
• PPC is courteous and helpful
• PPC maintain all the information strictly confidential
• Many of Pharma Companies are with PPC since 1987

What is typical about PPC setup?

PPC has three independent teams for handling RA activities :
Inspection Team : It performs cGMP Audit and Collects Documents required for Regulatory submissions
Documentation Team : It compiles the entire document systematically into CTD format
Solution Team : This team handles post submission queries from the regulators.

What is the basic strength of PPC for regulatory compliance?

• Unique team of Pharmaceutical Chemists, Pharmacologists, Pharmacists, Physicians, Microbiologists, Production and QC & QA experts
• Extensive experience in registering API, Pharmaceutical Dosage Forms, Excipients, Packaging materials
• Expertise in development issues, including Preclinical Pharmacology, Toxicology, Clinical Trials , Manufacturing, QC & QA , Product Development ,Stability studies, HPLC/GC Analysis, Chiral Chemistry, Polymorphism, X Ra Diffraction,
• Extensive experience in preparation and/or review of regulatory submissions including ANDA, EDMF, COS, 510(k), Drug Master Files, Orphan Drug Applications, etc
• Ability to provide expert advice on a broad range of pharmacology-toxicology issues associated with U.S. and international approval of biopharmaceutical products
• In depth knowledge and understanding of FDA expectations and regulations

What is specific product experience of PPC?

PPC holds unique experience in regulatory submissions for

• Antibiotics
• Anticancer Products
• Steroidal Products
• Cardiovascular Drug
• Monoclonal Antibodies
• Oral immediate and sustained release products
• Lyophilized and Spray Dried Products
• OTC Drugs and Nutritional Products
• Effervescent and Soluble Oral products
• Allergenic Products
• Peptides and Small Molecules
• Enzymes

Why you shall select PPC for outsourcing regulatory services?

PPC has compiled thousands of Regulatory documents for a wide range of bulk drugs, pharmaceutical dosage forms, biological, Excipients and packaging materials over a span of 30 years. The company is very much experienced in preparing :
ACTD ,CTD ,eCTD ,US DMF Type II to Type V and Canadian DMF ,cGMP Audits, Vendor Audits
If you need to know more about us and our services, please callus or mail us your query with followings details :
Full Name and Designation, Company Name and address Email ID and Phone

What are the ancillary services provided by PPC?

• Assistance for Product Development Plan (PDP)
• Development of overall regulatory strategy
• Review of preclinical pharmacology/toxicology studies/Clinical Studies
• Review of Chemistry, Manufacturing, & Control
• Regulatory submission (e-subs capability)
• GLP,GDP,GTP,GCP ,GMP , APR, Documentation, SS audits
• U.S. Agent services

What is the background of PPC?

PPC is a team of Regulatory Professionals who provide regulatory services especially on local and export registration of drug products, Excipients and packaging products with regulatory authorities such as.

PPC staff consists of experts in regulatory affairs, product manufacturing and testing, pharmacology/toxicology, facility inspections.

Many of our experts are former QA /QC Experts, Pharmacologists, Clinicians and CMC experts, certified FDA inspectors, and senior scientists from the Pharmaceutical industry.

PPC was founded on the realization that the regulatory process for drug products is very complex and varies from one country to the other and requires high degree of expertise based on the unique nature of the products.

While Regulatory Guidance Documents provide a necessary framework for product development strategies, practical regulatory and operations experience is a vital part of successful Market Authorization and post-market support.

PPCL is specialized in the preparation and review of ANDA, CTD and ACTD)

Click here to view biodata of our experts
Click here to view publication of PPC to support Regulatory compliance
Click here to view social support activities of PPC

Who initiated PPC and what is his background?

After qualifying for Post Graduate in Pharmaceutical Sciences and after serving as an FDA Approved Staff for Manufacturing Pharmaceutical/QC/QA for more than 10 years, Mr Rajkumar Gupta formally began his career at PPC. Today PPC has strong track record of 25 years for supporting thousands of Pharmaceutical Companies for Regulatory Compliance. Mr Rajkumar Gupta is committed to broaden and refine the regulatory activities in large interest of public health.

PPC will continue to support Indian Industry for marketing authorizations abroad. All of our offices are staffed with consultants with varying levels and areas of expertise to carry out your Regulatory Affairs projects.Our Project Team Leader will work with you to ensure that your requirements are met and that your completed work is delivered on time and, crucially, within budget

What is the position of PPC in Product Registrations?

PPC is a leader in providing Product Registration Documents/Files such as CTD, eCTD, ACTD, DMF, DOSSIERS, US DMF Type II to Type V to the healthcare industry worldwide. We have extensive expertise in registering wide range of API, Pharmaceutical Dosage Forms, Excipients and Packaging materials with US FDA, EDQM, Health Canada, TGA and national Drug Authorities in south East Asia, Gulf and CIS Countries.

What is the staffing policy of PPC?

We employ only top quality unsurpassed Full time Regulatory Professionals Consultants with deep regulatory knowledge to provide the most updated submissions. We provide regular training to update their knowledge and aptitude. The staff includes a number of former regulatory heads who have deep knowledge in FDA compliance issues. Our staff is frequently in touch with regulatory authorities such as US FDA, EDQM for the latest Guidelines and views on your submissions.

Do PPC have adequate facilities?

We have spacious office and sophisticated Computer systems and Peripherals for effective documentation, communication with regulatory authorities, video conferencing and consumer meetings.

What is the scope of services provided by PPC?

We can secure marketing Authorization in any of the following countries for your products

No.	Country	Regulatory Agency
1	USA	United States Food and Drug Administration (USFDA)
2	UK	Medicines and Healthcare products Regulatory Agency (MHRA)
3	European Union	European Medicines Agency (EMA) European Directorate for the Quality of Medicines (EDQM)
5	Australia	Therapeutic Goods Administration (TGA)
6	Canada	Health Canada (HC)
7	Japan	Pharmaceutical and Medical Devices Agency (PMDA)
8	France	Agence Francaise de Securite Sanitaire des Produits de Sante (AFSSAPS)  French Agency for the Safety of Health Products
9	Germany	Bundesinstitut für Arzneimittel und  Medizinprodukte, (BfArM) Federal Institute for Drugs and Medical Devices
10	Brazil	Agência Nacional de Vigilância Sanitária (ANVISA) - The National Health Surveillance Agency
11	India	Drugs Controller General of India (DCGI) who heads Central Drugs Standard Control Organization (CDSCO)
12	Switzerland	Swiss Agency for Therapeutic Products (SWISSMEDIC)
14	Singapore	Health Sciences Authority (HSA)
15	New Zealand	New Zealand Medicines and Medical Devices Safety Authority (MEDSAFE)
16	China	SFDA, China
18	Thailand	FDA Thailand
20	Russia	ROSZDRAVNADZOR
21	Nepal	Department of Drug Administration, Nepal
22	Israel	Ministry of Health,
23	Kazakhstan	Ministry of Health
24	Saudi Arabia	SFDA,
25	Romania	NMA,
26	Morocco	Ministry of health,
27	Zimbabwe	MCAZ,
28	Tanzania	TFDA,
29	Uganda	NDA,
30	Algeria	ANDS, Algeria
31	Brazil	ANVISA,
32	Guatemala	MSPAS,
33	Peru	DIGEMID
34	Trinidad and Tobago	Ministry of Health, o
35	Paraguay	MSPBS,
36	Jamaica	Ministry of Health, Jamaica
37	Cuba	CECMED, Cuba
38	Costa Rica	MINISTERIO DE SALUD,
39	Columbia	INVIMA,
40	Bahamas	PHABAHAMAS,
41	Mexico	COFEPRIS,
42	Argentina	ANMAT,
43	Chile	ISPCH,
44	Ethiopia	DACA,
45	Ghana	FDB,
46	Korea	KFDA,
47	Malaysia	Pharmaceutical Services, Ministry of Health,
48	Jordan	JFDA,
49	Namibia	NMRC,
50	Kenya	Pharmacy and Poisons Board,

Why people select PPC as their regulatory compliance partner?

People specifically tie up with us because PPC has extremely deep experience and knowledge in RA

• PPC have worked with over 1000 clients worldwide
• PPC have been in business for the last 25 years (established in 1987)
• PPC staff of consultants has over 100 years of cumulative industry and consulting experience.
• PPC staff is comprised of former QC/QA/R A/Production of API and Dosage Form Department
• Managers who understand your issues.
• PPC has Long-term relationships with regulators and Pharma Industry : We have over 100) clients out of which many are e with the company for the last 15 years.
• PPC has unique staff : The average service span of full-time employees at PPC is more than 10 years. This provides continuity and confidence to our clients;
• PPC has unique Fixed Price Business Model : PPC provides fixed priced services for what we will deliver to you. If it takes longer than planned, we accept the risk. We provide you a guarantee that you will get US DMF certification in the first first-time, as long as you follow our recommendations and process

Define the services provided by PPC?

Documentation /Product Registration/Marketing Authorization Services PPC provides following services on routine basis :

• US /Canadian DMF of all types
• Certificate of suitability for Products covered in European Pharmacopoeia (CEP)
• ANDA submission to US FDA
• 5 Module CTD/eCTD for submission with regulatory agencies such as MHRA, EDQM, US FDA TGA
• 5 Module CTD submissions with CIS Countries /African Content
• Drug registration in ROW
• 4 Module ACTD submissions in ASEAN countries
• PSUR Design and Submission
• New Drug Registration in India

Audit Services

Audit and Inspection for GMP Certification and COPP

Consultation Services

• Guidance on Design of BE /Dissolution Studies and Clinical Trials
• Guidance on Impurity Profiling
• Guidance on Facility design and automation
• Active Guidance on Indian Drug and Cosmetic rules and procedures
• International Drug Rules

Training Services

• CGMP Compliance as per national Guidelines
• Drug Regulatory Affairs (Product Registrations in International market)

Project Services

• Renovation and Updating of existing of existing facility as per current FDA Guidelines,
• Complete services for project designing, construction, and approval from Regulatory authorities

What is the overall achievement of PPC?

• Implemented more than 1000 Regulatory Submissions.
• Drugs Master File in CTD format
• Site Master files as per PIC/s & Local FDA requirement.
• Liaison with FDA for drug License
• WHO-GMP Product Certification.
• Schedule ‘M’ Requirements & documentation for compliance to Indian FDA’s norms
• Near to 100% first time certification record
• Training of large number of healthcare employees worldwide
• More than 200 plant audits
• Publication of more than 25 technical articles on GMP /Regulatory Compliance for Pharma Community

Our India Related Regulatory Achievements :

• cGMP audit of Manufacturing Sites as per WHO GMP,UK MHRA and US FDA
• Designing, Planning and FDA Licensing of New Pharmaceutical project
• Free sale Certificates, No conviction Certificate from FDA
• Site master File, Quality Manual, Training manual
• Liaison and licensing issues with DCGI
• Registration of foreign companies and Import Registration of products with DCGI
• UV Spectroscopy, Elemental Analysis ,NMR,IR, X Ray Diffraction, HPLC and GC Analysis, Impurity Profiling, Polymorphism Studies, calorimeter, Chiral Chemistry , structure elucidation, Forced Degradation Studies, stability studies, solubility profile for drug molecules
• Dissolution studies for Immediate, delayed and sustained release dosage forms
• Formulation development for new dosage forms.
• Assistance for Clinical Trail and Non Clinical Studies on lab animals

Which are the critical documents required for drafting DMF and Dossiers?

• Raw Material Specifications
• Finished Product specifications
• Packaging Material specifications
• Process Validation Records
• Manufacturing batch records
• In process Test specifications
• Stability Protocols and results
• Reference standard Details
• Method validation Details
• Development History
• COA
• Spectral data on API
• Dissolution and BE data
• Site master File
• Quality Manual

Describe pre submission/post submission services provided by PPC?

Our pre submission Services include :

• Review of technical documents provided by the client for completeness.
• Identification of missing studies and data
• Organization of missing information as required
• Customer review of entire submission
• Submission to FDA for marketing Authorization

Our Post submission service includes…..

• Follow-up with FDA/MOH on behalf of our client
• Responding to MOH concerns/queries about submission
• Filing variations, updates, Annual reports as required

Why PPC encourage filing CTD/ACTD?

PPC encourage filing CTD/ACTD documentation for the reasons :
It provides you legal authorization for marketing your products

• It gives you an edge over your competitors.
• It adds good will and reputation to your company and your products covered by DMF
• It built up confidence with customers. Even any unknown customer readily accepts your products.
• It Improve sales, broadens your market and cuts down marketing expenses
• It removes regulatory/legal barriers to enter into advanced market places
• It creates confidence in your workforce
• It tones up your knowledge end ensure higher quality for your products. It saves on reprocessing, reworking and on rejections.

How PPC solicits feedback about their services from customers?

PPPCL has a very wide customer network. The company has been participating in international Trade Show as per below to meet and thank their valuable support

What are the training solutions provided by PPC?

GIRA is the training arm of PPC. We provide both on-site and customized personnel regulatory training for regulatory compliance in following areas. Contact GIRA for a non-obligatory offer for your training needs.

For which products are covered by PPC for CEP?

PPLPL provides CEP services for the all the excipients and active drug substances listed in European Pharmacopoeia

What is the regulatory status of CEPs?

CEPs are recognized by all the member countries of the European Union and developing countries in the world. It is recognized all over the Europe plus many other countries such as Canada, Australia, New Zealand, Tunisia and Morocco in the world.

What are the Advantages of CEPs-

It is valid for 5 Years.
It is centralized approval of quality by EDQM. It eliminates the need of filing ASMF/EDMF in individual member countries involved in DCP/MRP Procedures

What is a DMF and what kind of services is provided by PPC for the same?

Drug Master File (DMF) is a submission to the Food and Drug Administration (FDA) that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs.

PPC provides registration and renewal services for the following types of DMF Type II :
Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation, or Drug Product
Type III : Packaging Material
Type IV : Excipients, Colorant, Flavor, Essence, or Material Used in Their Preparation

What is an ASMF? What type of service are provided by PPC

Active substance master file is a submission which is made to EMA, MHRA or any other Drug Regulatory Authority in Europe to provide confidential intellectual property or 'know-how' of the manufacturer of the active substance.

In simple words, “It is a submission made to European Drug regulatory agencies on the confidential information of Active Substance or Active pharmaceutical Ingredient (API)”.

Does PPC provide services for all the modules of CTD?

Yes. We provide services for total CTD or for any specific modules such as :

• Module 1: Administrative information and prescribing information
• Module 2: Overview and summary of modules 3 to 5)
• Module 3: Quality
• Module 4: Nonclinical Study Reports (toxicology studies)
• Module 5: Clinical Study Reports (clinical studies)

Does PPC provide customized information from Orange Book?

Orange book is a database on “Approved Drug Products with Therapeutic Equivalence Evaluations”, which is published by USFDA. It contains the list of drug products, approved on the basis of safety and effectiveness by the Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act. We can provide any customized information from the same.

Does PPC assists in MA from the following routes for Marketing Authorization in EU?

• Centralized Procedure (CP)
• Decentralized Procedure (DCP)
• Mutual Recognition Procedure (MRP)
• National Procedure (NP)

Yes. We do so.

SOCIAL ACTIVITIES OF PPC

No	Activities
1	Organization of Health Camps jointly with Social Bodies
2	Tree Plantation at Public Places
3	Counseling for Graduate  Post Graduate Studies for higher education in Pharmacy
4	Counseling for Regulatory Compliance
5	Organization of  Seminars and Workshops for the benefit of  Pharmacy Students
6	Continuous Education to Pharmacy Professional through Articles on LinkedIn
7	Guidance of Pharmacy Postgraduate  Studies and Projects
8	Assistance for Industrial Training to Pharmacy Students