IRA R. BERRY is President and Founder of International Regulatory Business Consultants, L.L.C., Freehold, New Jersey, USA. Ira Berry received his M.A. in Biology from Hofstra University, Hempstead, New York, USA and his M.B.A. in Management from Adelphi University, Garden City, New York, USA. He has created a consulting business with his extensive experience in the global areas of pharmaceutical manufacturing operations, quality systems, compliance, regulatory affairs and business development―for APIs and dosage forms. He provides instructions and conducts plant audits for CGMP compliance, quality systems evaluation, SOPs, preparing and filing Drug Master Files and dosage form product registrations and personnel training. His professional affiliations include his membership in the Generic Pharmaceutical Association and International Generic Pharmaceutical Association. Berry has worked extensively with Development and Task Force committees with the FDA and is a recognized health care manufacturing industry expert. He was Co-editor of Informa Healthcare’s first edition of The Pharmaceutical Regulatory Process, as well as the titles Pharmaceutical Process Validation and Validation of Active Pharmaceutical Ingredients. Berry also contributed to several chapters in the Encyclopedia of Pharmaceutical Technology.

ROBERT P. MARTIN is a consultant at RPMartin Consulting, Lebanon, Pennsylvania, USA. Dr. Martin received both his M.S. and Ph.D degrees from the University of California, Riverside, California, USA. Throughout his career, he has held positions at many pharmaceutical companies, including Forest Laboratories (as Associate Director of Quality Assurance), Duramed Pharmaceuticals (as Director of Quality Services), Merck & Co. (as Senior Scientist), and Johnson & Johnson (in several positions, including Manager of Quality Services). In these positions, he led efforts to improve performance in Research and Development by developing and implementing compliance and quality systems. At his consulting firm, he currently provides an array of pharmaceutical consulting services, including, such as vendor risk analysis and management, bioanalytical and analytical laboratory qualification/validation, manufacturing qualification/validation, auditing, documentation, CMC preparation, DMF preparation, and training.

"About the title" may belong to another edition of this title.

moluna

Greven, Germany

5-star seller

AbeBooks seller since July 9, 2020

Shipping rates from Germany to U.S.A.

Item	26 to 60 business days	26 to 60 business days
First item	US$ 54.67	US$ 54.67

Delivery times are set by sellers and vary by carrier and location. Orders passing through Customs may face delays and buyers are responsible for any associated duties or fees. Sellers may contact you regarding additional charges to cover any increased costs to ship your items.

Payment methods

Bank Wire Transfer
Check
Paypal

Store description

Online Handel nur mit Neubüchern

Seller's business information

Moluna GmbH

Engberdingdamm 27
Greven, Germany 48268

Contact sellerView this seller's itemsView seller's storefront

Terms of sale

Instructions for revocation/
Standard Business Terms and customer information/ data protection declaration

Revocation right for consumers
(A ‘consumer’ is any natural person who concludes a legal transaction which, to an overwhelming extent, cannot be attributed to either his commercial or independent professional activities.)

Instructions for revocation

Revocation right
You have the right to revoke this contract within one month without specifying any reasons.
The revocation period is one month with effect from the day,

on which you or a third party nominated by you, which is not the carrier, had taken possession of the products, provided you had ordered one or more products within the scope of a standard order and this/these product/products is/are delivered uniformly;
on which you or a third party nominated by you, which is not the carrier, had taken possession of the last product, provided you had ordered several products within the scope of a standard order and these products are delivered separately;
on which you or a third party nominated by you, which is not the carrier, had taken possession of the last part delivery or the last unit, provided you had ordered a product, which is delivered in several part deliveries or units;

In order to exercise your revocation right, you must inform us (Moluna GmbH, Engberdingdamm 27, 48268 Greven, Telephone number: 02571/5 69 89 33, Fax number: 02571/5 69 89 30, E-Mail address: abe@moluna.de) of your decision to revoke this contract by means of a clear declaration (e.g. a letter sent via post, fax or email). You can use the enclosed specimen revocation form for this, which however is not mandatory.

In order to safeguard the revocation period, it is sufficient that you send the notification about the exercise of the revocation right before the expiry of the revocation period.

Consequences of the revocation

If you revoke this contract, we shall repay all the payments, which we received from you, including the delivery costs (with the exception of additional costs, which arise from that fact that you selected a form of delivery other than the most reasonable standard delivery offered by us), immediately and at the latest within 14 days from the day on which we received the notification about the revocation of this contract from you. We use the same means of payment, which you had originally used during the original transaction, for this repayment unless expressly agreed otherwise with you; you will not be charged any fees owing to this repayment.

We can refuse the repayment until the products are returned to us or until you have furnished evidence that you have sent the products back to us, depending on whichever is earlier.

You must return or transfer the products to us immediately and, in any case, at the latest within 14 days with effect from the day on which you inform us of the revocation of this contract. The deadline is maintained if you send the products before the expiry of the 14 day deadline.

You bear the direct costs for returning the products.

You must pay for any depreciation of the products only if this depreciation can be attributed to any handling with you that was not necessary for checking the condition, features and functionality of the products.

Criteria for exclusion or expiry

The revocation right is not available for contracts

for delivery of products, which are not prefabricated and for whose manufacturing an individual selection or stipulation by the consumer is important or which are clearly tailored to the personal requirements of the consumer;
for delivery of products, which can spoil quickly or whose use-by date would be exceeded quickly;
for delivery of alcoholic drinks, whose price was agreed at the time of concluding the contract, which however can be delivered 30 days after the conclusion of the contract at the earliest and whose current value depends on the fluctuations in the market, on which the entrepreneur has no influence;
for delivery of newspapers, periodicals or magazines with the exception of subscription contracts.

The revocation right expires prematurely in case of contracts

for delivery of sealed products, which are not suitable for return for reasons of health protection or hygiene if their seal has been removed after the delivery;
for delivery of products if they have been mixed inseparably with other goods after the delivery, owing to their condition;
for delivery of sound or video recording or computer software in a sealed package if the seal has been removed after the delivery.

Specimen - revocation form

(If you wish to revoke the contract, please fill up this form and send it back to us.)

To Moluna GmbH, Münsterstr. 105, 48268 Greven, Fax number: 02571/5 69 89 30, Email address: abe@moluna.de :
I/we () herewith revoke the contract concluded by me/ us () regarding the purchase of the following products ()/
the provision of the following service ()
Ordered on ()/ received on ()
Name of the consumer(s)
Address of the consumer(s)
Signature of the consumer(s) (only in case of a notification on paper)
Date

(*) Cross out the incorrect option.

Standard Business Terms and customer information / data protection declaration

I. Standard business terms

§ 1 Basic provisions

(1) The following terms and conditions of business apply for all contracts concluded with us as the supplier (Moluna GmbH) via the websites AbeBooks and/or ZVAB. Unless otherwise agreed, the inclusion of your own terms and conditions is explicitly rejected.

(2) A ‘consumer’ in the sense of the following regulations is every natural person who concludes a legal transaction which, to an overwhelming extent, cannot be attributed to either his commercial or independent professional activities. The term ‘businessman’ refers to every natural person, legal person or legally responsible partnership that concludes a legal transaction in pursuance of his/its independent professional or commercial activity.

§ 2 Conclusion of the contract

(1) The subject-matter of the contract is the selling of products .

(2) If an article is placed by us with AbeBooks or ZVAB, the activation of the page on AbeBooks or ZVAB shall involve the binding offer to conclude a contract under the terms and conditions contained in the article page.

(3) The contract shall become effective via the online shopping cart system as follows:
The products intended for purchase are moved to the "shopping cart". You can select the "Shopping Cart" using the appropriate buttons on the navigation bar and make changes there at any time.
After calling up the “Checkout” page and entering the required personal data and payment and shipping conditions, all order information is then displayed again on the order summary page.
Before submitting the order, you have the ability once more to review or change any information here (you may also use the "back" button on the Internet browser), or to cancel the purchase.
By clicking the “Buy now” button to submit the order, you declare your legally binding acceptance of the order which makes the contract effective.

(4) The execution of the order and the sending of all the details necessitated by the conclusion of the contract take place via e-mail, in a partially-automated manner. Consequently, you have to ensure that the e-mail address that you have deposited with us is the correct one, and that the receipt of the respective e-mails is guaranteed. In particular, you have to ensure that the respective e-mails are not blocked by a SPAM filter.

§ 3 Right of retention, reservation of proprietary rights

(1) You can only exercise a right of retention if the situation in question involves claims arising from the same contractual relationship.

(2) The goods remain our property until the purchase price is paid in full.

(3) If you are a businessman, the following conditions also apply:

a) We retain ownership of the goods until all the claims arising from the ongoing business relationship have been settled in full. The goods subject to retention of title may not be pledged or transferred by way of security before ownership of the said goods changes hands.

b) You can re-sell the goods within the framework of an orderly transaction. In this regard, you hereby cede all the claims amounting to the magnitude of the billing amount that accrue to you as a result of the re-selling operation to us, and we accept the cession. Furthermore, you are authorised to collect the claim in question. However, insofar as you do not discharge your payment obligations in an orderly fashion, we reserve the right to collect the claim ourselves.

c) In a situation involving the combination and amalgamation of the goods subject to retention of title, we acquire co-ownership of the newly-formed item. This co-ownership corresponds to the ratio that exists between the invoice value of the goods subject to retention of title and the other processed items at the time of processing.

d) If you make a request of this nature, we shall be obligated to release the securities that are due to us, to the extent that the realisable value of our securities exceeds the claim to be secured by more than 10%. We are responsible for selecting the securities to be released.

§ 4 Warranty

(1) The statutory warranty rights are applicable.

(2) As a consumer, you are requested to promptly check the product for completeness, visible defects and transport damage as soon as it is delivered, and promptly disclose your complaints to us and the shipping company in writing. Even if you do not comply with this request, it shall have no effect on your legal warranty claims.

(3) If a characteristic of the goods deviates from the objective requirements, the deviation shall only be deemed to be agreed if you were informed of the same by us before submitting the contractual declaration and the deviation was expressly and separately agreed between the contracting parties.

(4)
Insofar as you are an entrepreneur, the following shall apply in deviation from the above warranty provisions:

a) Only our own specifications and the manufacturer's product description shall be deemed agreed as the quality of the goods, but not other advertising, public promotions and statements by the manufacturer.

b) In the event of defects, we shall, at our discretion, provide warranty by rectification of the defect or subsequent delivery. If the rectification of defects fails, you may, at your option, demand a reduction in price or withdraw from the contract. The rectification of defects shall be deemed to have failed after a second unsuccessful attempt, unless the nature of the goods or the defect or other circumstances indicate otherwise. In the event of rectification of defects, we shall not be obliged to bear the increased costs arising from the transport of the goods to a place other than the place of performance, unless such transport is in accordance with the intended use of the goods.

c) The warranty period shall be one year from delivery of the goods. The shortening of the period shall not apply

for culpable damage attributable to us arising from injury to life, limb or health and for other damage caused intentionally or by gross negligence;
insofar as we have fraudulently concealed the defect or have assumed a guarantee for the quality of the item;
in the case of items which have been used for a building in accordance with their customary use and have caused its defectiveness;
in the case of statutory rights of recourse that you may assert against us in connection with rights arising from defects.

§ 5 Choice of law, place of fulfilment, jurisdiction

(1) German law shall apply. This choice of law only applies to customers if it does not result in the revocation of the protection guaranteed by the mandatory provisions of the law of the country in which the respective customer’s usual place of residence is located (benefit-of-the-doubt principle).

(2) If you are not a consumer, but a businessman, a legal entity under public law or an institutional fund governed by public law, our place of business is the place of jurisdiction as well as the place of fulfilment for all services that follow from the business relationships that exist with us. The same condition applies to situations in which you are not associated with a general place of jurisdiction in Germany or the EU, as well as situations in which the place of residence or the usual place of residence is not known at the time of commencement of proceedings. This has no bearing on the capacity to call upon the court associated with another place of jurisdiction.

(3) The provisions of the UN Convention on Contracts for the International Sale of Goods are explicitly inapplicable.

II. Customer information

Identity of the seller

Moluna GmbH
Engberdingdamm 27
48268 Greven
Germany
Telephone: 02571/5698933
E-Mail: abe@moluna.de

Information regarding the conclusion of the contract

The technical steps associated with the conclusion of the contract, the contract conclusion itself and the correction options are executed in accordance to the regulations "conclusion of the contract" in our standard business terms (part I.).

Contractual language, saving the text of the contract

3.1 Contract language shall be English.

3.2 The complete text of the contract is not saved with us. Before the order is sent, the contract data can be printed out or electronically saved using the browser’s print function. After the order is received by us, the order data, the legally-mandated details related to distance selling contracts and the standard business terms are re-sent to you via e-mail.

Main features of the product or service

The key features of the goods and/or services can be found in the respective quote.

Prices and payment arrangements

5.1 The prices mentioned in the respective offers represent total prices, as do the shipping costs. They include all the price components, including all the incidental taxes.

5.2 The dispatch costs that are incurred are not included in the purchase price. They can be viewed by clicking the appropriate button on our website or in the respective quote, are shown separately over the course of the order transaction and must additionally be borne by you, insofar as free delivery is not confirmed.

5.3 The payment methods that are available to you are shown by clicking the appropriate button on our website or are disclosed in the respective quote.

5.4 Unless otherwise specified for the respective payment methods, the payment claims arising from the contract that has been concluded become payable immediately.

Delivery conditions

6.1 The delivery conditions, delivery date and existing supply restrictions, if applicable, can be found by clicking the appropriate button on our website or in the respective quote.

Unless a different period is specified in the item description or our delivery conditions, the goods are delivered within 3-5 days after the conclusion of the contract (in case an advance payment has been agreed upon, after the payment authorisation).

6.2 If you are a consumer, the following is statutorily regulated: The risk of the sold item accidentally being destroyed or degraded during shipping only passes over to you when the item in question is delivered, regardless of whether or not the shipping operation is insured. This condition does not apply if you have independently commissioned a transport company that has not been specified by us or a person who has otherwise been appointed to execute the shipping operation.

If you are a businessman, the delivery and shipping operations take place at your own risk.

Statutory warranty right

Liability for defects is governed by the “Warranty” provisions in our General Terms and Conditions of Business (Part I).

last update: 01.01.2022

Data protection declaration

Unless stated otherwise below, the provision of your personal data is neither legally nor contractually obligatory, nor required for conclusion of a contract. You are not obliged to provide your data. Not providing it will have no consequences. This only applies as long as the processing procedures below do not state otherwise.
“Personal data” is any information relating to an identified or identifiable natural person.

Responsible person
Contact us at any time. The contact details of the person responsible for data processing can be found in our legal notice.

Collection, processing, and transfer of personal data in orders
When you submit an order we only collect and use your personal data insofar as this is necessary for the fulfilment and handling of your order as well as processing of your queries. The provision of data is necessary for conclusion of a contract. Failure to provide it will prevent the conclusion of any contract. The processing will occur on the basis of Article 6(1) b) GDPR and is required for the fulfilment of a contract with you.
Your data is transferred here for example to the shipping companies and dropshipping providers, payment service providers, service providers for handling the order and IT service providers that you have selected. We will comply strictly with legal requirements in every case. The scope of data transmission is restricted to a minimum.

Duration of storage
After contractual processing has been completed, the data is initially stored for the duration of the warranty period, then in accordance with the retention periods prescribed by law, especially tax and commercial law, and then deleted after the period has elapsed, unless you have agreed to further processing and use.

Rights of the affected person
If the legal requirements are fulfilled, you have the following rights according to art. 15 to 20 GDPR: Right to information, correction, deletion, restriction of processing, data portability. You also have a right of objection against processing based on art. 6 (1) GDPR, and to processing for the purposes of direct marketing, according to art. 21 (1) GDPR.

Right to complain to the regulatory authority
You have the right to complain to the regulatory authority according to art. 77 GDPR if you believe that your data is not being processed legally.

Right to object
If the data processing outlined here is based on our legitimate interests in accordance with Article 6(1)f) GDPR, you have the right for reasons arising from your particular situation to object at any time to the processing of your data with future effect.
If the objection is successful, we will no longer process the personal data, unless we can demonstrate compelling legitimate grounds for the processing that outweigh your interests or rights and freedoms, or the processing is intended for the assertion, exercise or defence of legal claims.

last update: 10.01.2022

The Pharmaceutical Regulatory Process

Item description from seller

Bibliographic details

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About the title

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